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a A Canon Communications LLC Publication

July 2010

Validation for PREM


Devices E
Global Requirements
Are Intensifying for
Molded Components
p. 12

Complex Molding
Gaining Design Freedom
and Process Efficiency
p. 20

Simulation Trends
Can Finite Volume Models
Increase Accuracy?
p. 24

From the publisher of

MD100702 001 1 7/2/10 8:31:34 AM
JULY 2010 | Vol. 32, Number 7

12 Need A Little Validation?
Validating the injection molding process is no longer limited to
medical device components.
Ed Stockdale

17 When Molders Need to Be Choosy

Medical devices often have to be molded in a cleanroom
environment. But which cleanroom option is best? 17
Stephen Moore

20 Using Complexity as a Competitive Advantage

Complex injection molding can reduce costs and improve function
and aesthetics.
Dave Robinson

24 How Finite Volume Models Improve Accuracy

Some commercially available tools have eschewed the finite element
method for the finite volume method.
John Cogger
28 So Fresh, So Clean
A few analytical methods can help manufacturers keep residual
material product contamination away from their devices.
Tina May and Brent Shelley

31 Getting Up to Speed with Hot Runners

Hot runner systems are boosting their importance to the medical
device industry thanks to speed and precision.
Craig Kovacic

Departments 24

4 Editor’s Page
6 Contributors
8 Molding News
36 Molding Directory
37 Advertisers Index
Cover images courtesy of Eastman Chemical Co., Fraunhofer IZM, Innova
Engineering Inc., Mack Molding, Kaysun Corp., and Nelson Laboratories.

MD+DI would like to extend a special thank you to its sister publications Modern Plastics
Worldwide and Injection Molding Magazine for their contributions to this issue. 28

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Molding: Just One Piece of the

Manufacturing Puzzle
hen putting together a team for prod- ing or crazing. He said the material also exceeded
uct development, everything from the durability requirements, which he said was par-
material to the manufacturing must be ticularly valuable in mobile devices that are used
considered, and molding is just one of those pieces frequently or could be dropped or damaged should
of the puzzle. Recently, DD Studio put together a a patient fall.
team that included Eastman Chemical, Phillips Plas- To protect the device from water and fluids found
tics, and PolyOne to design and develop a mobile, in the hospital environment, it had to meet IPX7 re-
wireless, continuous vital signs monitoring system. quirements of withstanding water
The ViSi Mobile by Sotera Wireless Inc. is composed submersion for 60 minutes at a
of a wireless device that straps to a patient’s arm depth of 1 m. DD Studio worked
to monitor vital signs, such as blood pressure and with compatibility samples and
heart rate; a monitoring device to keep clinicians testing results from PolyOne to
connected to patients’ information; and a charging select the thermoplastic elasto-
station. mer GLS Versaflex OM 3060. Ac-
But according to Michael Swartz, growth strate- cording to PolyOne, the material
gist, DD Studio, the result would not have been pos- adheres to the Eastman Tritan
sible without a team pulled together from these four copolyester substrate to seal the
companies. Swartz spoke at a press conference at device housing, including the
MD&M East in June. speaker port and microphone,
from water seepage and protects
internal electronics.
Having the right Having the right material only
works if it can be manufactured successfully. To en-
material only works if sure the manufacturability of the design, DD Studio
it can be manufactured and the product development team worked with
successfully. Phillips Plastics Corp., which took the designs DD
Studio created and conducted a detailed design
“When Sotera Wireless approached us with this for manufacturability exercise and created market-
medical device design concept, it wanted the look entry prototype tooling.
and feel of a small, user-friendly consumer product, “Contemporary plastic materials, such as East-
but had a number of specific demands. The device man Tritan copolyester, are well-positioned to re-
had to be chemical resistant, durable, easy to clean, spond to the trend in the healthcare industry toward
and submersible under water. We weren’t sure the durable, reliable wireless devices that enhance pa-
design was possible,” said Swartz. “But, by working tient safety and comfort,” said Scott Hanson, global
with Eastman’s technical experts, we were able to industry leader, medical market segment, Specialty
specify Eastman Tritan copolyester as a material Plastics Business, Eastman. “Development of the
solution to make the innovative design a reality and Sotera Wireless device is an example of how early
meet the device’s performance requirements.” and ongoing interaction between material suppli-
The device’s lens, housing, printed circuit board ers and designers is truly effective to bring next-
assembly, and connectors are made with Eastman generation devices to the marketplace.”
Tritan copolyester MX711. The cold-swaging ability
of Tritan allows for fit and press assembly of the de-
vice, which offers a tight, smooth, continuous fit be-
tween parts; allows for joining parts without the use
of chemicals, adhesives, or mechanical fasteners;
and saves energy. By utilizing Tritan, Swartz said,
the device features superior resistance to chemicals Sherrie Conroy
used in disinfectants and cleansers without crack-

4 | July 2010

MD100702 004 4 7/2/10 8:40:42 AM
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MD100702 005 5 7/2/10 8:40:47 AM
John Cogger is president of
Innova Engineering Inc. (Irvine, Editorial Staff
firm specializing in nonlinear EDITOR-IN-CHIEF
Sherrie Conroy
analysis of plastics. Cogger
originally formed the company
as Leading Edge Design in 1987. Reach him at Departmental Staff Executive Officers
Craig Kovacic is global Marco Aguilera Charles G. McCurdy
manager of hot runner systems Robin Bernstein Michael Behringer
MI), an essential mold Tim Burns, Laura Pappada, Hector Torres Fred Gysi
technologies resource to Jeff Tade Michael Deering
him at Martin Schneggenburger Ron Wall
Orlando Lopez, Tanya Von Grumbkow Kevin O’Keefe
section manager at Nelson Jeff Polman, Derric Treece Roger Burg
Laboratories Inc. (Salt Lake City). William Baughman, Lucia Corona, Ricardo Esparza Jason Brown
since 2004. May previously held Michael Bartolomei Stephen Corrick
the position of quality manager Carlota Valle-Martinez Cherise Heckadon
of a certified EPA laboratory. Contact her at VICE PRESIDENT, HUMAN RESOURCES Terry Pasteris

Sales Staff
Dave Robinson is vice
Kaysun Corp. (Manitowoc, WI) Desiree Stygar Shannon Alo-Mendosa Tim Simone Tel: +44 1737 210746
Tel: 973/808-9445 Tel: 781/869-7989 Tel: 310/445-3767 Benelux, Ireland,
and brings a focus to tool NY, RI CT, ME, NH, VT AK, Northern CA, HI Scandinavia, UK
Canada: ON, QC
design. Robinson has worked in ACCOUNT EXECUTIVES SALES MANAGER Hermann Jordi
Rick Rosenberg ACCOUNT EXECUTIVE Diana Coulter Austria, Italy, Switzerland
the plastics industry since high Tel: 973/808-1221 Bob Johnson Tel: 310/445-3707 Tel: +41 32 6663090
school, when he was a part-time machine operator AL, DC, DE, KY, LA, MS, NJ, Tel: 781/932-9551 IA, ID, MT, OR, WA, WI,
during school breaks. Reach him via e-mail at Stacy Teicher Nicole Welter SENIOR ACCOUNT Statlistics Tel: 973/808-9254 Tel: 310/445-3754 EXECUTIVE Tel: 203/778-8700
Rich West Tel: 310/445-3704
Brent Shelley is a study Tel: 484/778-4605 IL, MN, ND, SD, Len Roberto
FL, MD, MI, OH, PA Canada: MB, SK Tel: 203/601-3738
director at Nelson Laboratories Robert Scolaro
Tel: 310/740-9076
ACCOUNT MANAGER Foster Printing Service
James Meire Tel: 866/879-9144
residue test. Shelley has been Helene Beck Tel: 310/445-3747 Tel: +44 1622 661363
Tel: 732/970-8960 AR, AZ, CO, KS, NV, OK, TX Benelux, Ireland,
with Nelson Laboratories since Sandra Martin
Scandinavia, UK
Andrea Marmalstein Tel: 310/445-4251
2006 and is an ASTM committee member. Contact Tel: 310/445-3737
him at MO, NE, NM,
Special Projects

Ed Stockdale is a process
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6 | JULY 2010

MD100702 006 6 7/2/10 8:43:16 AM
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DuPont Expands
Healthcare Offerings
Lab-on-a-Chip Project DuPont (Wilmington, DE) has
launched 10 new engineering

Counts on Plastics polymers targeting the healthcare

products and equipment market.
The company reports that its

esearchers from a healthcare offerings comply
consortium of Eu- with FDA, USP Class VI, and ISO
ropean universities 10993-5 and -11 regulations.
and small-to-large medical Sixteen of the products are
device developers and man- available as special control
ufacturers are using plastics grades that meet the standards
in various forms to create of manufacturing consistency
tiny lab-on-a-chip devices. required of many nonimplantable
Such devices could, for ex- medical products, with 12 grades
ample, enable consumers available in even more stringent
to quickly analyze the risk of premium control versions.
blood clots in their legs prior
to a long-distance flight, or
warn pacemaker patients Shown here is a sensor wristband with an Masterbatch
when electric smog levels electroluminescent display. Squelches Smells and
approach dangerous levels. Bacteria
One of the project’s goals is to use high-volume “This example shows clearly the possibilities for From Polyvel (Hammonton,
printing and plastics processes to ensure that polytronics...In order to build up the infrastruc- NJ) comes two new series of
such devices can be made and marketed at a price ture necessary for this, electronic systems have to masterbatches. The first of the
attractive for consumers. be produced in large quantities, in a cost-effective developments, the VA-series of
Not yet commercial but in an advanced testing manner on large substrates. And with polymer masterbatches, contains silver,
phase is the measuring device to ascertain the electronics, this would be perfectly possible,” says trichlosan, or proprietary agents
danger of blood clots during long flights. The Eu- Karlheinz Bock, head of the Polytronic Systems that effectively kill microorganisms
ropean Union–supported project is called DVT- division at IZM. Polymer electronics combines such as fungus, E. coli, and
Imp, and one of the active project members is the functional materials and electronics; for instance, salmonella. These masterbatches
Fraunhofer Institute for Reliability and Microin- one technique involves dissolving polymers and are suitable for inclusion in
tegration IZM in Munich, Germany. The lab-on- then recapturing them through a printing pro- most thermoplastics and can be
a-chip, which is the core of the diagnostic device cess, structured on flexible sheets. The EU proj- injection molded and extruded.
for deep vein thrombosis, was built and tested at ect on the feasibility of the system runs until the Because bacteria can emit
IZM. It is a small single-use cartridge, made of a middle of 2010. unpleasant odors, antimicrobials
polycarbonate plate measuring 3 × 22 × 70 mm, The sensor wristband (photo), which also was are often used as a method of
that acts as a tool for the biochemical analysis of engineered at IZM, is used for the long-term mon- controlling unwanted scents.
a drop of a passenger’s blood. The cartridge unites itoring of various body functions of older patients When the source of the smells is
two critical components in one device: a film or even athletes. Lighting elements, sensors, not bacteria, Polyvel’s ZO-series of
150 μm thick on which a filigree network with con- and polymer resistors printed on films are con- odor-managing masterbatches help
ductor lines and gold sensors for blood analysis is nected into one system with integrated circuits end-product scent improvement.
attached, as well as a 120-μm-deep fluid channel made of silicon. A 0.003-mm-thin resonance cir-
for bringing blood to the analysis elements. Inside cuit with an etched coil records electric smog. A
the sensor chamber, antibodies are integrated on 0.030-mm-thick interdigital capacitor attached PolyOne Distributes
electrodes that enable the analysis of the concen- to a film detects skin moisture. Comb-shaped, Dow Silicones
tration of blood-clotting markers. If the number is narrowly interlaced meanders made of copper PolyOne and Dow Corning jointly
elevated, then the risk of a thrombus (blood clot) bands 0.5 μm thick measure body temperature. announced in June at the Medical
is forming. —Matt Defosse Design & Manufacturing East
show in New York City that
Image courtesy of FRAUNHOFER IZM

PolyOne is now distributing Dow

OTHER STORIES Corning’s silicone products to
Bioplastics: The Proof Is in the Isotopes 9 | Elastomer Grades healthcare device manufacturers
Tailored for Medical Devices 10 | Eastman Opens Expanded and fabricators in the United
Tritan Plant 10 | States, Canada, and Mexico.

8 | JULY 2010

MD100702 008 8 7/2/10 8:47:59 AM
Bioplastics: The Proof Is in the Isotopes
B ioplastics continue to get a lot of press,
and are one of the fastest-growing seg-
ments of the plastics and packaging indus-
cycle, and both CO2 and H2O are very dynam-
ic molecules. “You can determine how CO2
moves in the universe and where it originat-
tries. More and more consumer packaged ed—shale gas, coal, [and] natural gas all have
goods companies have announced cam- a distinctive isotopic pattern. We measure it
paigns to integrate bioplastics into their as a family of molecules based on the carbon
packaging to reduce their carbon footprint, that is in it,” Woelk says. This material
and thus attract eco-conscious buyers. But Previously, this type of measurement re- analyzer helps
companies determine
how can processors be certain that the quired expensive and disruptive testing in whether packaging actually
amount of bioplastic content that is promot- specialized labs, but Picarro’s method gives contains the bioplastic specified.
ed in a material actually exists in the resin? both plastic consumers and suppliers a tool to
Picarro Inc., a Sunnyvale, CA, technology ensure that bioplastics content claims can be Woelk agrees that there’s a lot of hype sur-
company can help make that determination verified in minutes without disrupting ongo- rounding bioplastic products, and added that
with its Combustion Module-Cavity Ring- ing production. the manufacturers of medical devices, “regard-
Down Spectrometer (CM-CRDS) device for To determine whether a material is bio- less of their philosophical point of view,” want
stable carbon isotopic analysis. According plastic or “petroplastic,” the material is to support their consumers’ buying preferenc-
to Picarro’s CEO Mike Woelk, the CM-CRDS burned, and the composition of the CO2 is es with respect to being eco-friendly. “How do
makes analysis push-button simple for com- measured to determine where it originat- you know the truth? That’s what we provide
panies to verify the bioplastics composition ed. “There are very distinct signatures for and it’s as simple as you can get,” Woelk states.
of polymers or finished materials throughout CO2—soy, corn, rice, etc.,” Woelk says. “We “What we’re talking about is analytical-grade
the supply chain, whether on the factory floor make it easy—shop ready—so that you can results as good as any technology in the world
or at the distributor’s warehouse. put a piece of plastic into the device and im- can produce, and you don’t need to be a scien-
There are two massive cycles going on, mediately determine the material’s integrity tist to do the work.”
explains Woelk—the carbon cycle and water throughout the supply chain.” [See Bioplastics, page 11]

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MD100702 009 9 7/2/10 8:48:05 AM
Elastomer Grades Tailored for pursue the new monomer and polymer, a
Medical Devices team led by Rutstrom pushed forward in
2005 with the simultaneous creation of the

U nderlining its ongoing commitment to the

medical device industry, Arkema (Colomb-
es, France) now offers specialized grades for
and processing requirements for polymers have
become more rigorous. Arkema is introducing
this new Pebax grade as part of an ongoing
monomer and polymer production tech-
nologies, as well as market development.
The goal was to commercially launch the
medical devices marketed as the Pebax MED commitment to the medical industry, offering a material by 2007 at the triennial K show in
series of resins. range of grades specifically intended for today’s October in Düsseldorf, Germany. The com-
According to the supplier, these grades rep- devices. “Our highest-quality Pebax MED resin pany reached that goal and announced its
resent the highest quality of Pebax polymers for will be instrumental in helping OEMs meet intention to expand production, with those
medical applications, including devices exposed the growing demands of minimally invasive plans coming to fruition in the form of the
short term to bodily fluids (<30 days). Effective and intravascular devices by improving product newly inaugurated line.
January 1, 2011, Arkema will no longer offer performance and manufacturing yields,” says Making all of this possible was the work
standard-grade Pebax SA resins for any medical Basker Lalgudi, Arkema’s North American medi- of a handful of researchers, building from
applications. Pebax is a polyether block amide cal market manager. an investigation of a new monomer, tetram-
thermoplastic elastomer that can be injection All Pebax MED resin grades have passed ethyl cyclobutanediol (TMCD), that began
molded or extruded. USP Class VI biocompatibility testing and are in the late 1950s. At the time, Eastman
Pebax resin has been a preferred material sterilizable by EtO, gamma, and steam, key felt that the research could present a path
in medical devices, such as minimally invasive requirements for minimally invasive devices. to a high-heat material. That work, led by
catheters for angioplasty, since the mid-1990s. Pebax thermoplastic elastomer is manufac- Robert Hasek, was eventually abandoned.
It has gained recognition over other elasto- tured in the United States by Arkema Inc. (Phila- But in 2001, Emmett Crawford, a recently
mers for its excellent flexibility, kink resistance, delphia, PA) and marketed in North America hired research scientist, saw promise in the
torque transfer, low coefficient of friction, and through its strategic partner Foster Corp., a monomer that Hasek had studied. Work-
resistance to softening in the body. PolyMedex Discovery Group company (Putnam, ing with fellow researcher David Porter,
Over recent years, however, the functional CT).—Stephen Moore he started Eastman on the path that, after
much trial and error, would eventually lead
to Tritan.
Eastman Opens Expanded Tritan Plant Some 60 years prior, Crawford said a num-
ber of companies investigated TMCD, look-

E astman Chemical Co. (Kingsport, TN)

marked another important milestone
in the whirlwind development of its Tritan
drupled in dollar and volume terms, with
applications expanding beyond the initial
markets of reusable sports water bottles,
ing for a method to produce polycarbonate
(PC) from it. Eastman’s interest stemmed in
part from how well the chemical fit within
copolyester material with the May 13 open- house wares, and small appliances, to now its technology footprint. “The reason [East-
ing of a dedicated Tritan production plant include medical, infant care, bulk water, man] looked at it in the 1950s,” Crawford
at its Tennessee headquarters. and signage. Eastman did not disclose its said, “is it’s a great fit for our company,” on
“I’ve been in R&D most of my career, and investment to date in the material’s launch. the basis of the chemicals and intermedi-
taking something from lab scale to com- Company officials said that technology ates Eastman produces in Kingsport. The
mercial scale when you have to simulta- development began in earnest in 2004. After company has capacity in all of the elements
neously develop a new monomer, a new presenting a plan at the corporate level to that make up Tritan, helping it better con-
polymer, and the market, it’s just…we had
no right to believe we could actually do that,
but we did,” explained Dante Rutstrom, vice
president and general manager, specialty
plastics business, at the plant opening.
Eastman officials hosted trade and area
press as well as local and regional govern-
ment officials to mark the occasion, show-
ing visitors the new production line, as well
as the array of now-commercial products
Tritan is used in. Including the original de-
velopmental line, Eastman now has more
than 30,000 tn/yr of capacity for Tritan co-
polyester, all in Kingsport. The supplier has
plans in place to double that capacity by
2011 should demand continue to expand
at its current pace. Eastman said that in the
past 12 months, Tritan business has qua- Eastman’s dedicated Tritan production plant opened in May.

10 | JULY 2010

MD100702 010 10 7/2/10 8:49:19 AM
trol costs and production. Bioplastics [continued from page 9]

Pushing past the reluctance of some to The CM-CRDS is a tabletop unit that per-
pursue TMCD on the basis of past failures, forms a bulk specific isotope analysis and de-
Crawford successfully found a route to cre- livers isotopic carbon measurements of plas-
ate the monomer and a new copolyester tics and other packaging materials in roughly
from it. He would eventually share his work 10 minutes. The CM-CRDS is designed to run
with Hasek, who had toiled with the mol- up to 147 plastic samples consecutively with-
ecule decades before. out operator intervention, and with minimal
Mark Costa, Eastman’s executive vice training and setup time. Woelk notes that
president, specialty polymers, coatings, and The company’s copolyester material has a Picarro is in the very early stages of commer-
surprisingly long history.
adhesives and chief marketing officer, said cialization of its technology, even though it
Tritan’s rise has been fueled by concerns ment, it understood early on that its con- has been around for several years.
about the safety of PC, and more impor- sumer safety credentials would need to be Picarro sees the regulatory environment
tantly, its chemical forerunner, bisphenol well established. To that end, in addition to evolving as a result of the green movement,
A (BPA). In the past, where its heritage its own testing for endocrine disruption and “More regulations will evolve by hook or by
copolyesters could compete with acrylic, estrogenic and testosterone activity, it has crook,” Woelk says. “I think people think that
vinyl, and some styrenics, Tritan’s proper- completed independent third-party testing these bioplastics markets are all big estab-
ties enable it to target PC—a market that of the material. “Even when we began, we lished markets, but they’re not. There are
has a global annual volume of 700,000 tn by had a sense that we really want to go the very few companies that are making any
Eastman’s estimation. “So, 60,000 tn out of extra mile here in understanding the safety money in the green space. And there are is-
a 700,000-tn/yr market leaves a lot of room of our materials and the monomers that go sues surrounding bioplastics, such as com-
for additional build for us,” Costa said, “but into them,” Rutstrom said. Motioning to a mingling bioplastics and petroplastics, that
PC is a huge market, and lots of things like spot on the conference table, he added, “if contaminate the resin stream. It will be im-
optical media, we have no interest in and the letter of the law stops here, we want to portant for manufacturers to produce scien-
won’t be pursuing.” stop here,” dropping his hand farther along tific results to match the suppliers’ claims.”
In order for Eastman to target PC replace- the surface. —Tony Deligio —Clare Goldsberry MT

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MD100702 011 11 7/2/10 8:49:30 AM

Medical Molding:
How to Validate
the Process
Validating the injection molding process is no
longer limited to medical device components.
It is increasingly becoming a requirement
throughout global industries.

A metrologist conducts first article measure, or test the product is maintained tn/in.3 of the projected area of the molded
inspections, which consist of the
measurement of all dimensional callouts and calibrated as required. Additionally, it part is adequate.
on the molded product part print. affords the opportunity to benchmark spe-
cific installation and process conditions that Cooling circuits in the mold should be

successfully validated process is can prove valuable over the life of a mold- adequately sized to satisfy the Reynolds
stable, dimensionally centered ing program. For example, if a process isn’t equation for turbulent flow for good ther-
within the required tolerance, and yielding the same dimensional stability after mal coefficient (typically 1.0 gpm of flow
minimizes rejects with significantly fewer months of run time, the problem could be for each 0.5 in. of cooling line is adequate.
adjustments from run to run. The adop- attributed to a number of circumstances, See the sidebar, “Definitions.”). Additionally,
tion of process validation principles and including restricted water circuit flow, a dif- the cooling lines should be sized equally to
disciplines has proven beneficial for both ferent style of nozzle body or tip, the use of achieve balanced cooling.
new and existing programs. It is essential, similar but different equipment, etc. The inspection area of the molded prod-
however, to first establish an agreed-upon All of these and other deviations can con- uct should be benchmarked for location
procedure for the validation, known as the tribute to process and dimensional varia- and lighting influence, as well as cleanli-
installation, operation, and process qualifi- tion, as well as instability. By documenting ness attributes, e.g., lumens, particulate in
cations or IQ/OQ/PQ. This should be done the initial installation settings, fewer per- ppm, etc. The equipment and techniques
in conjunction with the customer. sonnel will be needed to investigate and de- used to inspect and accept product must be
Early interaction identifies and resolves termine the root cause of the rejects. More calibrated and documented. Additionally, all
areas of concern between the two parties. It importantly, satisfying customer delivery equipment used in the direct manufacture
also details the equipment needed to manu- and quality requirements will be much more of the product needs to be calibrated in ac-
facture, test, and measure product, and it de- consistent. cordance with ISO and GMP guidelines.
fines dimensional tolerances, molding tech- When selecting the molding machine of
nique, engineering studies, the substance of choice, keep in mind the following criteria: Operation Qualification
the qualifications themselves, and the quali- OQ is at the heart of evaluating and defin-
fication approval and acceptance criteria. ■ Real-time closed loop technology (electric ing the injection molding process. Through
Typically, the desired acceptance criterion molding machines have recently demon- the use of analytical processes, engineer-
for critical dimensions is a Cpk of ≥1.33 (see strated more consistent repeatability and ing studies, and statistical and dimensional
the sidebar “Definitions“ on p. 13). reduced cycle times). evaluations, one can identify areas of con-
The IQ/OQ/PQ procedures are outlined ■ The shot size of the screw should utilize cern that need to be addressed early in the
below. It’s important to note that the use of 25–75% of barrel capacity (ideally, 33– program. Examples might include a small
all or any of these disciplines has proven ben- 66%) to avoid minimal or excessive resi- runner system that would limit pressure,
eficial for process and dimensional control. dence time, either of which can influence a part that won’t fill evenly, or less-than-
process variation. desirable aesthetics that might result from
Installation Qualification ■ Machine tonnage should provide enough shear, dimensional concerns, and so forth.
The purpose of IQ is to demonstrate that the clamping pressure to keep the mold fully In these cases, the mold can be modified to
equipment and facility used to manufacture, closed and prevent flash; typically 5–10 address the concerns before building a pro-

12 | JULY 2010

MD100702 012 12 7/2/10 8:52:05 AM
duction tool, thereby minimizing lead times and first article inspection (FAI). As a starting
to production. point for these studies, use the resin manufac-
For a new molding program, it is benefi- turer’s recommended process settings.
cial to perform process development and a The short-shot study demonstrates that
design of experiments (DOE) with a proto- the cavity or cavities fill evenly or balanced,
type mold prior to building a production the injection pressure required to fill the part
tool. The purpose of performing process de- approximately 95–99% (used for velocity-to-
velopment is to minimize areas of the pro- pressure-changeover definition) is not lim-
cess that cause variation, e.g., pressure limi- ited due to the runner system in the mold,
tations, shear rates or viscosity variations, and there are no mechanical issues that pre-
inadequate changeover definition, proper vent the mold from successfully cycling. A measuring machine is adjacent to its
pack and holding pressures, and time. The In-mold rheology defines the best shear medical molding cell to minimize the time
required for first article inspections on new
DOE defines which process attributes affect rate (injection rate) to minimize variation medical molding programs.
specific dimensional responses, the influ- during fill. This rate varies from one resin to
ence on the response, and the interactions another and is influenced by the geometry defines the optimal dimensional process
between them. From the two studies, one of the mold and cavities. A level shear rate window. These process limits will then be
can confidently define an ideal process with slope is more desirable and will exhibit less challenged and evaluated. The challenges
a predicted dimensional outcome. variation than one on a sharp incline or de- consist of three different runs: low, high,
Process development consists of a short- cline (see Figure 1). and nominal process challenge runs. Each
shot study, in-mold rheology, a stability or cav- A stability or cavity-to-cavity balance run run is equal in run time and evaluated for
ity-to-cavity balance run, gate-seal analysis, demonstrates that the process to the point dimensional, functional, and cosmetic
and a pack-pressure study, as well as a DOE of velocity-to-pressure changeover is stable considerations in relation to the product
and balanced. It also validates process capa- specifications and tolerance. The results
bility through the use of Cp and Cpk relative may demonstrate conditions that do not
Definitions to the molding process itself (see the side- meet the desired acceptance criteria, in
The following terms are commonly used in bar, “Definitions”). which case the process, tolerance, mold,
validating molding processes. A gate seal or freeze study (holding and or specification needs to be modified and,
4.1 Cp: Estimates what the process would pack time) confirms when the influence of if necessary, the processes rerun to verify
be capable of producing if it could be centered injection within the cavity and runner system conformance.
in tolerance. Assumes that the process output is complete. An improper gate-seal or freeze- Beyond process development and DOE,
is normally distributed. Cp demonstrates that time setting can cause process variation or an in-mold cavity pressure transducer
the process is in control without respect to the add unnecessary additional cycle time. equipped with a temperature sensor can
present dimensional tolerance, so tolerance The pack-pressure study identifies the also be beneficial. This equipment illus-
can be adjusted with confidence. influence that the pack and holding pres- trates and defines proper velocity-to-cavity
4.2 Cpk: A globally recognized measure- sure have on dimensional characteristics. It pressure settings and cooling time (see Fig-
ment of the process capability index or sta- defines a proper pack-pressure process win- ures 2 and 3, p. 14). The sensor and transduc-
tistical prediction of potential product at risk dow and evaluates how the mold operates er combination minimizes the difference in
that could be out of dimensional tolerance. under these conditions. Dimensional studies cavity pressure between the beginning and
Based on (4) sigma (standard deviation), a are then necessary to evaluate these progres- end of fill, thereby reducing in-mold stresses
Cpk of ≥1.33 is the commonly recognized ac- sive influences on the molded product. while enhancing dimensional and product
ceptance specification for medical devices. Once the process window for each pro- stability. Recent studies comparing process
This means that 63 of every million parts cess attribute has been defined, these set- variation both with and without the use of a
produced (ppm) are at risk of potentially being tings can be used to define the DOE. The sensor and transducer demonstrated a pro-
out of dimensional tolerance (99.99%). A Cpk DOE defines the optimum process win- cess and dimensional stability improvement
of ≥1.67 based on (5) sigma potentially yields dow and its respec-
a process that is at risk of producing one part tive influence on 12972
Apparent Viscosity PA.S

out of tolerance specification for every ppm each dimensional 11972
Low 11972
or 99.9999%. The benefit of these disciplines response. A series 10472
Normal 9972
is realized through the reduction of potential of experiments are 9472
risk of out-of-tolerance product, fewer assem- run, and the influ- High 8972
Process 8472
bly issues with mating components, and less ences are evaluated 7972
Limit 7472
scrap and down time due to rejects. statistically. A DOE 6972
4.3 Reynolds number equation: The prediction is made, 5972
measure and calculation of turbulent flow, and an additional 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2
which translates into thermal heat transfer run confirms that
or cooling. the DOE predic- Shear Rate, 1/s
tion is accurate and Figure 1. Defining proper In-mold rheology process window.


MD100702 013 13 7/2/10 8:52:10 AM

validated so that they are readily available
90 if needed. Typically, the spare part or com-
Cavity ponent validation process consists of one
80 Temperature similar PQ run that demonstrates accept-
70 able capability.
Scale (%)

60 Temperature
17-1 Stable Other Considerations
50 Document Control and Process Docu-
Y17-2 Cavity
Pressure mentation. The ongoing documentation of
40 Gate Sealed
Y1-1 the process needs to be maintained in a con-
30 1-1 trolled environment in accordance with ISO
Figure 2. In-mold pressure transducer and temperature sensor application. 13485 standards. This is essential in main-
taining and ensuring that the same process
of greater than 50% over time when the sen- Potential risks and safeguards are there- is run from one run to another.
sor and transducer combination was used fore assigned to these areas, e.g., special Variation versus Profitability. The use
(see Figure 3). measurement devices or equipment, 100% of these analytical and engineering concepts
inspection, etc., to ensure that product of will stabilize process and dimensions, as well
First Article Inspection this nature is appropriately rejected. as profitability. It’s worth noting, however,
An FAI consists of the measurement of all di-
mensional callouts on the molded product Process Qualification
part print. Typically two samples are taken PQ demonstrates that the process is stable
from the nominal process run or from the and dimensionally capable and that it produc-
DOE conformation run and submitted to es a molded part that meets the customer’s
metrology for measurement. The dimen- expectations. Typically, PQ is accomplished
sional results are evaluated by the customer by running the defined or nominal process
and for conformity. through three separate runs. These runs are
It is common to find out-of-specification a simulation of three separate production
conditions, which need to be evaluated for runs and should be a minimum of four hours
significance, followed by corrective action. in length for each run with a shutdown pe- A technician defines the optimal
Usually this requires a dimensional change riod between each run. Additionally, three dimensional process window for a DOE.
on the part print or a tooling modification. different lots of resins should be used dur-
Once the FAI is approved by the customer, ing the PQ, which represents actual molding that sufficient resources and specific equip-
process qualification begins. conditions and variation over time. Samples ment are necessary to successfully incorpo-
should be taken at even intervals through- rate these concepts into a business strategy.
Process Failure Effects and out each run, labeled sequentially, and then Resource requirements include management
Mode Analysis (pFEMA) submitted to metrology for measurement staff; process, quality, and tooling engineers;
Depending on the end-use of the product, a and conformity. Once the PQ and FAI have process technicians; metrologists; and tool-
pFEMA may be conducted to identify poten- been approved, these samples should be kept ing personnel experienced in Cp/Cpk disci-
tial areas of concern. There may be specific for the life of the program for reference. This plines and tight-tolerance molding. Specific
critical dimensions, for example, that need to retaining policy helps with answering ques- equipment needs include well-maintained
be monitored closely, because if even one is tions as programs develop and transition. peripherals and molding machines, check
out of specification periodically, it may cause If the PQ is unsuccessful and the molded ring and barrel assemblies capable of hold-
significant failure or risk with the product. part does not meet customer expectations, ing a molding process to a tight tolerance,
the root cause needs coordinate measurement machine and vi-
With Psi Tranducer With out Psi Tranducer to be evaluated sion system equipment for measuring tight
Lower Control Limit (LCL) Nominal and the two parties geometric dimension and tolerance profiles,
Upper Control (UCL)
must work together and tool room equipment.
Without 46.75
Transducer to define and accept The business approach that integrates
44.75 Angle

Poor Cpk (.683) a resolution. process validation touches many areas of the
With The qualification company, so the company’s commitment to
Transducer 44.75 of spare mold or the process is essential to its success. And
Good Cpk (8.75)
tooling components while significant investment is required, it is
43.75 directly related to recouped through stable molding programs
the molded part, where profitability is maintained over time.
1 6 11 16 21 26 31 e.g., spare core pins,
Serial # lifters, etc., should Ed Stockdale is a process engineer for Mack-
Figure 3. Typical cavity pressure transducer (with and without a sensor). be evaluated and Medical/Mack Molding Co. (Arlington, VT). 2

14 | JULY 2010

MD100702 014 14 7/2/10 8:52:16 AM
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MD100702 016 16 7/2/10 8:52:30 AM

Robotic part placement

onto a covered conveyor
enables transfer of
fragile parts to a
separate cleanroom for
postprocess operations.

Keeping It Clean
leanroom molding is essential entire machine in a cleanroom. This is best
Which cleanroom for serving the medical segment, suited for molders that are operating several
option is best? Well, and various options exist for machines under cleanroom conditions and
manufacturing anything from discrete need to integrate large assembly systems
that depends. components to complex assemblies in into the cleanroom concept, according to
a pristine environment. So what clean- Jochen Hirt, application department man-
room alternative should you choose? ager at Arburg (Shanghai) Co. However, this
It very much depends on your application solution can only obtain ISO 7 standard at
and business strategy. best, which is essentially equivalent to the
What may appear to be the simplest so- Class 10,000 U.S. federal standard typically
lution to medical molding is to locate the required as a minimum for cleanroom mold-
ing. Good manufacturing practice (GMP)
standards are generally also required for
cleanroom molding, and these specify maxi-
mum bacterial count in addition to particle
count. GMP Level C equates to ISO 7.
One issue with the fully integrated ap-
proach is, “If the cleanroom malfunctions
and air quality is adversely affected, you
have to shut down all your machines,” says
Jack Liu, application engineering manager
at Demag Plastics Machinery (Ningbo) Co.
Ltd. A more flexible and lower-cost method
is to enclose only the mold space in a clean-
room environment by installing a laminar
A laminar flow box mounted over the mold area keeps molded parts clean while removing many flow element on top of the machine’s clamp-
contaminant sources from the clean area. ing end. The clean air module is mounted on


MD100702 017 17 7/2/10 8:54:40 AM

a traveling frame above the clamping unit,

allowing easy mold installation from above.
In its simplest form, parts are molded in
this miniature cleanroom area and dropped
onto a covered conveyor that then trans-
ports them to a cleanroom attachment for
robotic or manual assembly and packing.
“Being much smaller, ISO 5 is attainable in
this attachment,” says Liu.
With this modular clean air hood tech-
nique, the ambient air is drawn in via radial
fans and clean air is produced via a prefilter
and a suspended matter filter (HEPA H14).
An integrated ionization module produces
ionized air, which ensures the neutraliza-
tion of electrically charged components.
This reduces electrostatic charging of the ISO 7-standard cleanrooms can be sufficient for medical molding tasks.
molded parts. Through the permanent air
flow, a high level of air circulation is ensured the machine. This solution achieves ISO 6/7 at KraussMaffei, notes that when mold-
within the clamping unit. The fan also cre- standards. ing takes place under GMP Class B (ISO 5)
ates an overpressure in the interior of the conditions, the surrounding gray room area
mold, which effectively prevents the pen- Room in a Room should be at least GMP Class C (ISO 7). Pro-
etration of particles from the ambient air. KraussMaffei also offers a room-in-room duction in a Class 5 cleanroom makes post-
Needless to say, for fragile parts that option whereby the clamping end of the mold cleaning or sterilization unnecessary
might be damaged by free-fall and a sorter machine protrudes into a sealed clean- in many applications, although it may be
flap, robotic takeout is essential. The clean- room. This option can cater to cleanliness stipulated by end-users.
room area must therefore be expanded to en- up to the ISO 5 standard. For mold chang- Demag’s decentralized method for in-
compass the robot and conveyor placement ing, service, and repairs, the machine is corporating an injection machine plus
area. Arburg’s offering for this situation is a retracted on rails until the clamp is in the automation into a cleanroom is dubbed a
cleanroom production cell with its Multilift H gray room area and the white room is com- cleanroom cabinet with roof construction.
horizontally operating robotic system. pletely sealed off by a second metal plate at Takeout, assembly, and packing are carried
KraussMaffei Technologies GmbH (Mu- the front of the clamp end. out under an ISO 7 environment. The ma-
nich) has a different take on this option in This option was adopted by Rexam chine may also be enclosed in the cabinet
that the robot accesses the mold space from Pharma GmbH (Neuenburg, Germany) for in its entirety.
an adjacent cleanroom. The overpressure in molding vials from cyclic olefin copolymer Using a decentralized approach, Arburg’s
the white room causes the clean air to flow (COC) with TPE closures for injectables. Hirt says that newcomers to cleanroom
through the tunnel and flow out through The ready-to-fill vials leave the cleanroom molding can benefit in that they can start
the chute on the injection machine. The closed and packed. Thomas Hörl, who over- with just one machine and add cleanroom
production area is isolated from the rest of sees product and technology management capacity as they go. “If individual machines
are temporarily not required for cleanroom
production, they may be undocked to pro-
duce standard parts,” he adds.

Workers are the main source of particulate
contaminants, accounting for around 40%
of emissions in a cleanroom, and removing
them from the equation, or at least minimiz-
ing their presence, goes a long way toward
eliminating particles. The next largest source
on the list is the injection machine itself, and
here, various techniques exist to minimize
contamination. While Demag’s Liu says
that fully hydraulic machines are capable of
KraussMaffei’s room-in-room approach minimizes the volume of work area held achieving ISO 7 standards when contained in
at high cleanroom level, while facilitating machine servicing and toll changes. cleanrooms, all-electric machines can oper-

18 | JULY 2010

MD100702 018 18 7/2/10 8:54:46 AM
This allows the injection molding machine
to be kept clean much more effectively.” Fur-
ther, raising the machine by 100 mm using
antivibration pads makes cleaning under
the machine considerably easier.
Closer to the tool, multiple cooling cir-
cuits can be routed directly to the fixed or
moving mold platen for the mold cooling.
“This tidy routing prevents unnecessary
trailing of the hoses,” says Hirt. Powder
coating is also used throughout Arburg ma-
chines for wear and scratch resistance. Hirt
insists that a properly configured hydraulic
machine can run in a cleanroom equally as
well as a hybrid or all-electric machine.
In this cleanroom variant, parts are molded in a laminar flow clean area, and KraussMaffei recommends its EX Series
then drop onto a covered conveyor for transport to a separate cleanroom. all-electric machines for medical molding
applications. The Z-toggle has only eight
ate at up to ISO 5 standards if water-cooled. turbulence in the mold space. pivot points, all of which are lubricated
“Fan cooling is not as good for cleanroom “During production under cleanroom with completely encapsulated circulating
environments, although ISO 6 is technically conditions, it is very important that the [hy- oil. All drives are water-cooled, and plas-
achievable,” says Liu, who adds that direct draulic] machine can be cleaned easily,” says ticating and injection are driven by two
drive is also preferable over belt drive. An- Arburg’s Hirt. “For this purpose, the dis- coupled direct drives.
tistat metal coatings and PVC coatings for tributor manifolds of the hydraulic circuit
mobile elements are also employed, while can be contained in a powder-coated sheet Stephen Moore is senior editor of Modern
use of perforated metal sheet minimizes air metal housing located at the machine base. Plastics Worldwide. MT

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MD100702 019 19 7/2/10 8:54:55 AM

Complex Injection Molding

for Competitive Advantage
With careful planning, complex injection molding can result in reduced
costs, optimized function, and improved aesthetics.

omplex injection molding repre-
sents a direct route to competi-
tive differentiation. It provides
the design freedom and process efficiency
required to create new features and incor-
porate new technologies as quickly and
cost-effectively as possible.
Complex injection molding is defined
by simultaneous complexity in four criti-
cal areas: part design, mold design, mate-
rial selection, and process control. To make
successful medical products, OEMs should
choose a molding partner that can offer
them expert guidance in these areas. This
article explores when to address pertinent
molding considerations in complex injec-
tion molding.

Why Use Complex Injection

With complex injection molding, additional Decisions regarding each part’s unique cosmetic, functional, and volume characteristics
should be made as early as possible in the design phase.
materials—from dissimilar polymers to
metal components and other nonplastics—
can be integrated during molding. These In addition to streamlining production tate the validation requirements for all
materials and features are combined in and reducing costs, incorporating a deco- physical, chemical, and compositional
the molding process to facilitate assembly ration or functional item into the injection aspects of medical products. Regulatory
by adding metal inserts, threading for fas- process improves quality. Machine-paced control of implanted devices is especially
teners, and incorporating elements such production always yields higher quality critical, for example, because these types of
as lenses. Such features can also optimize product by eliminating or greatly reducing products carry the greatest risks. Complex
function by creating waterproof seals and human involvement and inconsistency. It injection molding addresses the design and
increasing durability. also reduces potential process variances production challenges posed by such strict
Improving aesthetics can also drive the introduced by secondary machining or controls.
decision to use complex molding. For ex- joining operations. Just as important,
ample, some OEMs may want to color a complex molding yields more predictable Part Design Considerations
polymer to make the device more appealing quality because manufacturers are able to Many of the crucial decisions involved in
to patients—notably in pediatric applica- maintain consistency no matter how many complex injection molding should be made
tions—or, they may want to integrate deco- units are produced, ensuring that tight as early as possible in the design phase,
rative elements such as metal flake, gloss, or tolerances are met and sterility is always when adjustments can be made without
some other proprietary pattern. Such visual maintained. a significant effect on the total costs and
uniqueness can differentiate products with- Furthermore, the medical market is sub- product timeline. For example, the place-
in a manufacturing line or separate them ject to regulatory compliance demands ment of ejector pins and gating—the point
from the competition. from organizations such as FDA that dic- where the plastic enters the mold—is

20 | JULY 2010

MD100702 020 20 7/2/10 8:56:12 AM
critical aesthetically and stylistically. A vis-
ible knit line, where the flow fronts of the
molten material meet, may be objection-
able to the customer. If such marks cannot
be strategically located to a place on the
part where they will not be visible, they can
sometimes be disguised by texturing the
mold. Either way, the part designer must
plan for them.
If multiple materials are to be used, the
polymers must be chosen carefully for com-
patibility to ensure a permanent chemical
bond. Different plastics undergo thermal
expansion at different temperatures, and
any incompatibility can become a serious
issue. For example, polysulfone, a polymer
commonly used in medical applications,
will not bond with polypropylene, which in
turn bonds weakly with nylon, styrenic, and An OEM’s evaluation process for a complex injection molder should include a site
urethane-based elastomers. visit to assess the quality of the plant’s environment and personnel.
Process complexity is added when a part
requires metal inserts or pass-through cor- must maintain its appearance. This means single-cavity prototype molds with smaller
ing. For example, the metal elements being no fading, hazing, or yellowing of the plas- runs to hardened steels used for complex,
added to a mold often require preheating to tic after exposure to sun, fluorescent light- multicavity molds to support greater pro-
reduce thermal shock, improve retention ing, chemicals, or other potentially harsh duction volumes.
properties, and prevent flash—thin, sharp, elements. Because medical device production leans
or unsightly areas that can form in the pass- toward high volume and high complexity,
throughs due to stress (e.g., molten plastic Mold Design Considerations these requirements increase the importance
meeting cold metal fasteners) during the The development of the mold or tool is the of selecting the proper steel for building the
molding process. The presence of flash can heart of the injection molding process, the tool. The determining factors are based di-
have an adverse effect on the performance stage from which everything else flows. The rectly on the goals and expectations of the
of the product or require secondary opera- ultimate success of the part is determined project, ranging from total quantity sought
tions to be removed. when the engineering team designs, cre- to the finish quality needed. Budgets for
All of these issues highlight the impor- ates, and maintains the mold—accounting both time and cost can influence material
tance of a robust part design that antici- for the materials to be used and the quan- choice as well (see Table I).
pates possible problems with complex in- tity of the item to be produced. Poor choices Softer metals, such as P20 steel and
jection molding and prevents them through in any aspect of the mold development pro- aluminum, are easily machined and there-
thoughtful planning. A careless part design cess ultimately results in poor products, re- fore less costly to mold. However, because
can lead to weak points, aesthetic flaws, or gardless of part design, material choice, or they are prone to wear faster, they are
overall part failure. process control. less commonly used in medical device
A robust part doesn’t just meet the origi- The type and durability expectations for manufacturing.
nal requirements its designer intended; it a mold determine which material is used to Stainless steel is an appropriate tool steel
also stands up to the wear and tear—or make it. For example, aluminum is relatively for medical applications because it resists
even abuse—it is subjected to during daily inexpensive and easily machined but it of- corrosion, pitting, and wear while sup-
use. For example, many medical devices fers limited longevity. Therefore, it should porting the smooth finishes required for
are moved often, from room to room or be used only for small and finite produc- cleanliness in a medical setting. In general,
even between ambulances and hospitals, tion runs—a rare case in medical device the harder the steel, the more effort and ex-
so they must be designed and built to with- applications. As a result, molds for medical penditure is required. Each additional step
stand the jostling and bumping that ac- applications are nearly always steel. They used to create the mold drives up time and
companies such use. Aesthetically, a device can range from soft steels used for simple, cost. But these harder steel molds also last

<10,000 10,000—200,000 200,000—1 MM

Aluminum X
P-20 X X X
Tool steel (various grades) X X
Table I. Rules of thumb for material choices are based on project volume requirements.


MD100702 021 21 7/2/10 8:56:19 AM

Materials tion without breaking down. Certainty that

Considerations a part will be exposed to chemical steriliza-
Just as important as selecting the tion will limit the list of polymer options,
material for the mold is choosing as will applications in which medications
the material for the part. Deter- will be transmitted via plastic parts and
mining the proper material for tubing.
a complex injection molding Sterilization is another factor to con-
application should begin with sider. Many medical devices must with-
a discussion between the plas- stand regular sterilization treatment by
tics engineer and the OEM. radiation, chemicals, or the high heat and
This decision requires informa- steam of autoclaving. Table III shows some
tion about five defining factors common material choices that steriliza-
(outlined below), as well as any tion requires.
outstanding special needs, such The need to mold dissimilar plastics also
as the frequency and method of plays a role in material selection. One of the
sterilization. most common complex injection molding
Physical Load. The impact techniques used in medical device manu-
expectations of the part must be facturing is the multishot method, which
determined so that it will stand is required to add soft polymers for ergo-
up to the conditions of everyday nomic and waterproofing features (such
use without fatigue. Any degrada- as keypads, grips, protective bumpers, and
tion can lead to life-threatening seals) over a hard plastic substrate, as in an
part failure. impact-resistant device body. Other times,
Mechanical Function. The overmolding of silicone tubing may be
The high-heat resins required to withstand
autoclaving require specialized oil heating particular polymer must be right for its ap- required.
equipment to bring the molds to temperatures plication. For example, a part of a surgical By accomplishing these steps during
in excess of 325°F. device that holds a blade must be made molding, manufacturers eliminate costly
considerably longer and return high-quality from a polymer with appropriate stiffness. and inefficient secondary steps from the
parts with consistency. Thermal. Exposure to fluctuating and production process. It can also result in
Other steels used for complex injection extreme temperatures must be accounted higher quality because the material it-
molding medical devices and equipment for. Most medical devices are kept indoors, self can be monitored during production
include high-carbon varieties, such as but some portable devices or ambulance through cavity pressure feedback—a pres-
H13. These varieties contains a negligible equipment may be exposed to extreme heat sure reading of the resin as it is going into
amount of impurities—an important fac- or cold. Polymers must be chosen to endure the mold. The feedback provides data on
tor in heat treating—and are economical such conditions. the consistency of the pressure and where
to purchase in larger sizes. See Table II Environmental. Consider whether the correction is needed. Causes for inconsis-
for a breakdown of types of steel and their device will be implanted or used in direct tent pressure include a change in the vis-
characteristics. contact with bodily fluids. If so, the poly- cosity of the molten material.
Corrosion resistance in a mold is es- mers must be biocompatible in accordance The mold and the process must be de-
pecially important with the use of ma- with FDA regulations (as well as further signed to suit the part and materials. No
terials that have a high degree of acid- testing requirements depending on the medical OEM would tolerate a soft-touch
ity. These materials include resins in device). keypad separating from one of its handheld
the PVC family or those with certain Chemical. Exposure to chemicals is also monitoring devices during use. Nor would
added agents, such as flame retardants, a factor. Most hospital-grade disinfectants it accept a waterproof seal failing because
which are often required to meet the are strong formulas, often in an alcohol materials were improperly selected or the
UL standards for resins used in medical de- base. Plastics chosen for the exposed parts process to manufacture it was not expertly
vice manufacturing. of a device must stand up to their composi- designed.
The last material concern of importance
Type of Steel General Use Criteria is whether a project requires high-heat
S-7 General all-purpose, heat-treatable tough steel. Normal wear resistance. resins. The high-heat resins such as poly-
General all-purpose, heat-treatable hard steel. Higher wear resistance and less sulfone, which are required to withstand
A-2 autoclaving, have their own set of process
considerations. These materials are more
D-2 High-wear applications.
difficult—and therefore more costly—to
420 SS Medium wear resistance, high polish, corrosion resistant, not as hard. work with, mainly due to their high melting
H-13 Medium wear resistance. Can be nitrided for surface lubricity with flex strength. points, which complicates everything from
Table II. A profile of the different types of steel that can be used to make a mold. safety concerns to the molding process.

22 | JULY 2010

MD100702 022 22 7/2/10 8:56:25 AM
Method Amorphous Polymers Semicrystalline Polymers
Polyether ether ketone (PEEK) offers best resistance.
Polyphenylsulfone (PPSU) offers best resistance.
Polyamides and polypropylene can withstand finite number of
Polycarbonate and polysulfone can withstand finite
Autoclaving number of cycles.
Some polyethylenes can withstand shorter cycles at lower
Acrylonitrile butadiene styrene (ABS) and polyester
should not be autoclaved.
Polyethylene terephthalate (PET) should not be autoclaved.
Chemical (ethylene oxide) Withstand very well. Withstand very well.
Radiation Most withstand well; polycarbonates will discolor. Most withstand well.
Table III. Certain polymers are better suited for specific sterilization treatments.

As an example, polysulfone has a melting Supplier Considerations Conclusion

point of 700°F versus 500°–550°F for typical The importance of selecting the right Complex injection molding can provide a
resins. Oil, rather than water, must be used manufacturing partner increases in di- medical device and equipment manufac-
to control mold cooling, requiring a longer rect proportion to the complexity of the turer with competitive differentiation, but
molding process and different equipment— task at hand. With all that is at stake in it requires highly specialized equipment,
with different risks involved. Heating oil the medical device industry, the OEM’s skills, and engineering expertise. OEMs
also takes longer and metal-braided hosing evaluation process should be rigorous. that take advantage of the complex injec-
must be used as opposed to rubber. These The process should cover every aspect tion molding process can enjoy the ben-
higher demands mean higher risks for both of a partner’s operations, equipment, efits of high-quality parts and devices with
safety and deviation. Because the mold personnel, track record, culture, and fi- optimal efficiency and low total production
itself can reach 325°F (whereas a water- nancial health. A site visit should also be costs.
heated mold typically reaches 180°F), it is part of this process because it provides
subject to higher levels of thermal expan- the best method for assessing the quality Dave Robinson is vice president of engi-
sion, which adds complexity to the overall of the supplier’s plants environment and neering at Kaysun Corp. in Manitowoc,
mold design process. personnel. WI. MT

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MD100702 023 23 7/2/10 8:56:32 AM

Using Finite Volume

Models in Mold Filling
Finite volume simulation can increase accuracy in models.

ost modern mold filling simu- fixed mesh grid. In the finite element meth-
lation software uses some type od, the mesh grid points actually move,
of solid or shell element mesh to simulating the flow behavior.
define the part geometry. These range from There are pros and cons to both ap-
simple midplane element models meshed proaches, the main practical advantage
with 2-D shells to 2 ½-D surface meshing of finite volume codes being the accuracy
strategies. of the solution for fluid flow and the speed
Increasingly, some of the high-end soft- with which you can get a solution. Finite ele-
ware packages are using full 3-D elements. Figure 1. 2 ½-D element filling simulation. ment codes tend to be computationally ex-
With few exceptions, these codes almost pensive, as a large mesh can create inordi-
exclusively use four-noded tetrahedral el- nately large numbers of nodes, all of which
ements—not always the best choice when must translate to simulate the flow behav-
modeling fluid behavior. ior. Typically, the finite element method is
As the fundamental physics of mold fill- more stable, and provides better results for
ing simulation is really a fluid flow problem, those primarily interested in stress tensor
several codes are now commercially avail- outputs, such as in structural analysis. Fi-
able that use the finite volume method as nite volume codes are useful for fluid and
opposed to the more common finite ele- gas flow problems, and are used extensively
ment method. Figure 2. High-order 3-D element filling in CFD codes.
simulation. The speed advantage inherent in finite
Finite Element versus volume codes is significant for simulating
Finite Volume There is a significant difference in how these thermoplastic flow when using full 3-D ele-
Most mold flow simulation is finite ele- tools work. ments, because it is necessary to create large
ment based, a technology made popular in The finite volume method differs in that numbers of elements to accurately capture
structural analysis codes. Some of the newer the mesh grid nodes and integration points the part geometry. For example, a good rule
codes, such as Moldex3D, are finite volume. are fixed, and the fluid moves within the of thumb is to provide a mesh density of at

Figure 3. High-order 3-D elements with gate Figure 4. High-order 3-D elements, hybrid Figure 5. A cutaway shows inner mesh
modeled. mesh hexahedrals with tetrahedrals. resolution.

24 | JULY 2010

MD100702 024 24 7/2/10 9:19:37 AM
least three 3-D elements spanning the cross
section of a wall thickness. Propagated over
even a small part, this can create element
counts in the hundreds of thousands, which
can make it difficult to get timely solutions.
Larger parts can and do create 3-D element
counts in the millions.
The use of finite volume technologies
can substantially reduce the solution
time to run these types of mold fill simu-
Figure 6. High-order boundary layer elements used with solid tetrahedrals. lations. These jobs are very large, and the
Moldex3D solver allows for parallel pro-
cessing (we typically use an eight-core
machine) to get a solution of a model this
size in a few hours. Such a large model may
not even run on a finite element solver,
and many mold filling codes do not sup-
port parallel processing.
High-Density 3-D Elements. Armed
with a high-performance finite volume
solver, we can now use high-quality 3-D el-
ements to model plastic flow, and get solu-
tions in minutes or hours instead of days,
with high-fidelity results. Figure 1 shows
Figure 8. Actual molded part results a mold filling analysis using typical 2 ½-D
Figure 7. Predicted results in the simulation. (short shot). fusion elements, while Figure 2 shows the


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MD100702 025 25 7/2/10 9:19:44 AM

runners as well as in
the part geometry.
Results Correla-
tion. One of the best
ways to validate the pre-
dicted results of a mold
flow is to compare with
a short shot study after
the fact (Figures 7-9).
Fiber Orientation
and Postprocessing.
One of the more inter-
esting aspects of this
type of analysis is the
Figure 9a (left) and 9b. Predicted results versus actual short shots. ability to import mold
filling analysis results
same part using high-order 3-D elements in higher-order elements to be used on the into structural analysis software for more
a finite volume solver. The differences are part bounding surfaces and lower-order realistic loads analysis. Most structural
dramatic. With computationally efficient 3-D elements to be used in the part interior finite element analysis uses the flawed as-
finite volume solvers, we can also expand for better resolution of temperature effects sumption that thermoplastics are isotropic
our element library to include higher-order on the critical boundary layer. An example (uniform material properties) and therefore
elements, such as hexahedrals, to capture can be seen in Figure 6 (p. 23). cannot accommodate the effects of molding
much more accurate fluid flow behavior. Gate/Runner Modeling. One of the on structural part performance. This can
Drilling into the mesh resolution, we can most important parts of mold filling sim- lead to unanticipated part failures when
see a typical high-order mesh in Figures 3, ulation is the gate and runner modeling. weld lines, material flow lines, and part den-
4, and 5 (p. 22). Note that these mesh struc- This is an area that is often overly simpli- sity changes occur in highly loaded areas.
tures are a hybrid of several element types. fied by software applications, and poor When the mold filling solver runs the
In addition to using these types of hybrid accuracy here can negatively influence warp load case in a typical molding simu-
meshes, we can combine these methods results. Best results can be achieved using lation, we (automatically) convert to the
into a boundary layer strategy, allowing high-order 3-D elements in the gate and finite element method, as we are now inter-
ested in finite strains and residual stresses
to predict warp accurately. This output file
can then be used as an initial condition for
a structural FEA, bringing along the follow-
ing attributes:

■ Fiber orientation.
■ Material density variations.
■ Residual stresses (flow and thermally
■ Initial strain.

Figure 10. Typical fiber orientation plot.
These attributes are critical to under-
standing the part performance when
structural loads are applied. When cou-
pled with orthotropic or anisotropic mate-
rial data, accurate structural FEA can be
performed on injection molded parts. Fig-
ure 10 depicts a cross section of a molding
simulation showing fiber orientation of a
glass-filled part, while Figures 11 and 12
show the warp prediction with and with-
out consideration of fiber orientation.

Figure 11. Typical fiber warp results plot with Figure 12. Typical fiber warp results plot John Cogger is president of Innova Engineer-
fiber orientation. without fiber orientation. ing Inc. (Irvine, CA). MT

26 | JULY 2010

MD100702 026 26 7/2/10 9:19:52 AM

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MD100702 027 27 7/2/10 9:19:59 AM

Analyze This: Device

Cleanliness Testing
Three analytical methods can help manufacturers avoid residual material
product contamination.

ost medical device manufac- to integrate with a patient’s bone, but oils that are crucial to the release of clean and
turers know the importance remaining on the metal could reduce new safe medical devices.
of putting a product through bone growth or inhibit integration, causing RMM analysis uses three methods to
rigorous cleaning and testing before it is the device to be ineffective or unsafe. evaluate the different phases of manufac-
released into the market. Standard sterility RMM analysis quantifies the residuals on turing and cleaning—gravimetric analy-
and biocompatibility tests are an essential the device and identifies them. It establishes sis, total organic carbon (TOC) analysis,
part of manufacturing protocols. However, a baseline against which manufacturers can and detergent residual analysis by ultra-
some manufacturers may not fully under- discover if the amount of residuals changes violet/visible (UV/VIS) spectroscopy. All
stand the different ways a product can be as they improve their assembly process. three tests are quantitative and designed
contaminated during the production, pack- Manufacturers can use RMM analysis to remove surface contamination but are
aging, and cleaning processes. To avoid as a tool to monitor the cleanliness of pro- not intended to remove or assess leachable
detrimental contamination, manufacturers duction at any point, including the final components from a device. The assess-
should test their devices, including those product. Knowing how much residue is on ment from these tests can be used to de-
made via injection molding, using residual a device or component allows for the estab- termine cleaning efficiency as well as aid
manufacturing materials (RMM) analysis. lishment of effective cleaning procedures in the validations of cleaning and rinsing
The Basics of RMM Gravimetric Analysis
Analysis (ASTM F2459-05). Quantify-
Any contaminants such ing extractible residue by gravi-
as oils, lubricants, releas- metric analysis involves using
ing agents, and detergents aqueous and nonaqueous sol-
transferred to the product vents to extract contaminants
during the manufactur- such as oils, salts, and other
ing or cleaning process are materials from the surface of
RMM. From extracting the medical devices.1 After the de-
device out of the mold to vice is extracted, the solvent
cleaning and packaging, is evaporated and the remain-
device contamination can ing residuals are weighed and
occur just about anywhere quantified. Gravimetric analy-
along the production pro- sis does not determine the
cess. Those residues that specific elements making up
remain on a product can be the residue, but it measures the
potentially cytotoxic and quantity of the total amount of
Images courtesy of NELSON LABORATORIES

harmful, particularly for de- residue coming off the device.

vices implanted inside the If the analysis quantifies
body. For example, a metal significant residue, the labo-
device may be designed ratory may also identify, or
qualify, residue by Fourier
Scientists are shown
weighing a crucible for transform infrared spectros-
gravimetric analysis. copy. A general analysis or

28 | JULY 2010

MD100702 028 28 7/2/10 9:21:10 AM
interpretation of the sample 1.2 facturers, including molded de-
spectrum can reveal the pres- vice manufacturers, should con-
ence of certain types of com- 1 sider having this analysis method
pounds such as hydrocarbons performed on each type and size

Absorbance (AU)
and amines. The laboratory can 0.8 of device because different devices
also identify the compounds by may require different or addition-
comparing the sample spectrum 0.6 al rinsing to completely remove
to the spectra of target com- detergent residuals. For example,
pounds. Identifying the residue rinsing a smooth artificial knee is
may be important when a manu- much easier than rinsing a device
facturer is trying to control the with grooves, pockets, lumens, or
source of residue production. 0 mated surfaces.
TOC Analysis. TOC analy- 190 200 210 220 230 240 250 260 270 280
sis is the most sensitive of the Wavelength (nm) Why RMM Analysis is
RMM series of tests. The analy- Essential
Figure 1. An example of a detergent residual analysis U/V printout.
sis is quantitative and detects Several critical reasons why
carbon-based materials such as medical device manufacturers
oils, adhesives, and detergents on a prod- Detergent Residual Analysis. Manu- should perform RMM analysis include the
uct, but does not pick up inorganic residue facturers use a variety of cleaning agents following:
such as metals and salts. to clean their devices. Unfortunately,
these cleaning agents can leave behind po- ■ Cleanliness of device: RMM analysis
tentially harmful residual material. Deter- helps manufacturers determine wheth-
The gent residual analysis detects detergents er they are producing a clean and safe
manufacturer by UV/VIS spectroscopy. device.
Because each detergent absorbs UV ■ Cleanliness of manufacturing process:
must evaluate light differently, the laboratory validates RMM analysis can determine cleanliness
the results and each one for accuracy, precision, linearity, throughout the manufacturing process.
determine how limit of detection, and limit of quantita- Without this series of tests, manufactur-
tion. For this validation method, manufac- ers may not know whether they are over-
much residual turers must provide a full-strength sample cleaning their devices and molds and
material is of detergent that is used in the cleaning therefore wasting time and money on
allowable based process. Detergent residual analysis also unnecessary rinses and cleaning cycles.
uses water extraction and sonication to The analysis also informs the manufac-
on the device’s identify the detergent left on a device. The turer whether its cleaning processes are
designed use. lab compares device extracts to the deter- working by showing how much residue is
gents calibration curve for quantification left behind on the products.
TOC analysis involves extracting devic- (see Figure 1). ■ Designing cleaning processes: Manufac-
es in USP-purified water by sonicating or Detergent residual analysis confirms that turers design their cleaning processes to
shaking, to remove surface contaminants. devices are being adequately rinsed. Manu- remove residue from a device, but clean-
An aliquot of the extraction solvent is ana-
lyzed on a TOC instrument to determine
how much organic carbon is on a device or
component. Alternatively, the manufac-
turer can use swabs to evaluate clean-in-
place components and equipment. After
swabbing the targeted component, the
swab is sent to the lab to be immersed in
USP-purified water and analyzed.
The manufacturer must evaluate the
results and determine how much residual
material is allowable based on the device’s
designed use. For example, if a device is
designed to be implanted in the body, it
needs to carry fewer organic residuals
than if it is a smaller, functional part of a
bigger device used outside the body, such
as a gear in a machine. A scientist loads samples on a TOC analyzer.


MD100702 029 29 7/2/10 9:21:15 AM

ing agents can add additional contami- ■ Mold-release agent transfer: Manufac- to determine acceptable levels of residue
nants to a device and render it unclean turers often use mold-release agents based on the application and patient-con-
and possibly cytotoxic. In some cases, to remove devices from a mold, which tact duration. They should also establish
the cleaning process can makes the de- can leave residue on the device. RMM limits for the cleanliness and safety of their
vice more cytotoxic than before cleaning. analysis ensures that the device is not medical products.
RMM analysis can help manufacturers picking up unexpected residues or that Medical device manufacturers can save
time and money down the road if they ana-
lyze their devices, including those made
Manufacturers can use RMM in molds, for RMM. The analysis method
analysis as a tool to monitor the streamlines and enhances process efficien-
cy to ensure safety while reducing product
cleaniness of production at any and regulatory liabilities. Conducting such
point, including the final product. analysis can prevent manufacturing from
halting when a problem or changes in the
ensure that cleaning and rinsing process- these residuals are at acceptable levels process arises.
es are effective and producing a device postproduction.
that is safe and patient ready. ■ Creating a baseline measurement: RMM References
■ Increased FDA involvement: FDA is in- analysis creates a baseline or a gauge for 1. ASTM F2459-05. 2005, “Standard Test Method
creasingly examining the cleanliness of a cleaning process. This can serve as a for Extracting Residue from Metallic Medical
Components and Quantifying via Gravimetric
medical devices. RMM analysis provides useful validation criterion to ensure con- Analysis” (West Conshohocken, PA: ASTM In-
substantiated proof that products have sistent production of a safe product. ternational, 2005).
undergone meticulous cleanliness test-
ing. This documentation can be extreme- Conclusion
ly useful to support a regulatory submis- There are no established regulatory limits Tina May is chemistry section manager at
sion or in the event of an FDA or notified of cleanliness for residual analysis. Manu- Nelson Laboratories (Salt Lake City). Brent
body audit. facturers should perform a risk assessment Shelley is study director at the company. 2

MD&M Midwest MEDTEC Ireland
September 28–30, 2010 September 22–23, 2010
Donald E. Stephens Convention Center Radisson SAS Hotel
Rosemont, IL
OrthoTec Galway, Ireland MEDTEC UK
>ÞÊ£nq£™]ÊÓ䣣 «ÀˆÊÈqÇ]ÊÓ䣣
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October 13–14, 2010 Winona Lake (Warsaw), IN
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Minneapolis, MN BIOMEDevice MEDTEC Europe
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Anaheim Convention Center Orlando, FL MEDTEC France MEDTEC India/
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Convention Center Forth Worth, TX December 1–2, 2010
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30 | JULY 2010

MD100702 030 30 7/2/10 9:21:20 AM

Hot Runners and the

Evolving Medical Industry
Hot runner innovations may be able to provide speed and precision for
medical molding.

old makers, mold designers, and mold-
ers in industrial manufactur-
ing have used hot runner
technology for at least 40 years. The
systems are becoming especially im-
portant within the medical products
industry. Hot runners may help de-
vice OEMs reduce costs, improve
part quality, and increase speed An electric valve gate system provides
to market. technology for precision molding while also
Hot runner systems are well- reducing waste.
suited for molding medical prod-
ucts for multiple reasons. The tech-
nology opens the door to a variety of options for molders, all Hot Runners for Medical Processing
of which provide reduced material use and faster cycle times. The primary benefit of hot runner systems is speed. Fractions of
Recent innovations in technology can also provide power and a second in cycle time add up quickly and can significantly affect
speed in cleanroom environments, which are required for pro- the bottom line.
ducing many medical products. Hot runners also cut cost by reducing waste. The technology
eliminates runner waste and any costs necessary to regrind or dis-
Hot Runner Basics pose of scrap. The technology also enables a variety of increased
A hot runner system is an assembly of heated components used process efficiencies, as well as the capability for extreme precision.
in plastic injection molds that inject melted plastic into the cavi- An example of how exact hot runner systems can be is the electric
ties of the mold. A hot runner system usually includes a heated valve gate. This machine has variable pin positioning in 0.001-in.
manifold and a number of heated nozzles. The main task of the increments, giving a significant level of control to molders.
manifold is to distribute the plastic entering the mold to the vari-
ous nozzles, which then meter it precisely to the injection points Top Considerations for
in the cavities. Selecting a Hot Runner System
By contrast, a cold runner is simply a channel formed between Hot runner systems were created out of a need to mold plastic parts
the two halves of the mold, for the purpose of carrying plastic from fast and at a low cost. When they are selected, installed, and work-
the injection molding machine nozzle to the cavities. Each time ing properly, these systems can improve part quality, as well as en-
the mold opens to eject the newly formed plastic parts, the mate- able fast processing speeds, low scrap, low labor costs, high-volume
rial in the runner is ejected as well, resulting in waste. production, and efficiency. But achieving the maximum potential
Hot runner systems consist of a steel block, machined with an requires proper knowledge, planning, design, and execution.
internal passageway for molten resin. Heaters affixed to the pe- The primary consideration for selecting a hot runner system is
rimeter of the steel block heat the manifold from the outside in, to determine whether the product needs to be molded in a clean-
enabling an even heat inside the block. Melt is then distributed room. A contaminant-free environment is often a prerequisite for
throughout the heated manifold block, fed into a heated nozzle, producing medical products, especially Class II and Class III medi-
then sent into the final gate well—or bubble—just prior to passing cal devices. Producing these types of items outside a cleanroom can
into the part cavities. When designed properly, the system achieves create serious risks for both patients and medical staff.
maximum material processing capability while eliminating resin There are products, however, such as bedpans or food trays, that
waste per injection cycle. do not require cleanroom standards. These types of items can often


MD100702 031 31 7/2/10 9:25:44 AM

be sanitized after the standard molding process due to advance- that doesn’t require hoses, oil, or other potential contaminants. The
ments in gamma radiation and other sterilization procedures. electric technology is suited for cleanrooms.
Once you’ve established whether the application requires clean-
room molding, the next step is to determine the tolerance for gate Thermal Gate versus Valve Gate
vestige based on the nature of the part. From there, you can ulti- Once the power source has been chosen, molders must determine
mately choose which nozzle, and therefore which system, is the whether to use a thermal gate or a valve gate. This decision is based
most appropriate for the application. primarily on whether the final part has any tolerance for gate ves-
tige, the mark a gate can create on the part.
Preparation for Hot Runner Although gate vestige can be undesirable for many plastic prod-
Systems ucts, it’s particularly problematic in the medical field. Surgical gloves
Before starting a project, meet with prevent the spread of disease within medical facilities and are a criti-
the materials supplier, the toolmaker, cal part of overall safety for patients and medical staff. Plastic parts
and the hot runner manufacturer to produced with any sharp or jagged edges, as a result of gate vestige,
determine how each will contribute. can potentially tear through thin gloves and pose an assortment of
Working together from the beginning safety risks. Vestige points can be trimmed off of plastic items if nec-
allows the OEM to consider options essary, but these secondary processes reduce efficiency.
and ensure that all parts of the pro- Thermal gates are generally the more common and less expensive
cess will fit together. gate option. They are particularly suited for high-cavity-count molds
The most important recommenda- with close cavity pitch dimensions. With thermal gates, plastic hard-
tions should come from the material ens in the gate area as it cools, creating a barrier between the molten
supplier. The residence time of the ma- plastic and the cooled part, and leaving a small vestige point. The
terial is important. The supplier should molder must take this into consideration ahead of time and accom-
provide information on how much sheer modate accordingly. It is not uncommon for molders to put a dimple
Thermal gates are a
common option that the material can take and on the proper flow in a part so that the vestige is below the surface and not easily felt.
can accommodate materials. Figuring this out first is especially Valve gates, the other type of gate option, typically do the best job
high-cavity molds. important for producing medical products, eliminating vestige and producing suitable medical products. They
because the resins used for medical devices function by shutting off the flow of plastic mechanically, with a
are typically highly engineered with specific processing parameters. physical barrier between molten and cooled plastic. They are good
In medical applications, it’s also important for a material’s sur- for superior gate cosmetics, sequential part filling, and eliminating
face to be as nonporous as possible to prevent bacterial growth. the potential for sharp edges.
Producing this type of resistant surface usually demands highly Some circumstances exist in which plastic parts are too small to
engineered machines. This is also common when producing parts use a valve gate. In those cases, use a hot-to-cold runner technique
for the food industry. to feed a tiny runner into the small part. When the part ejects from
With the material supplier, determine whether a hot runner sys- the mold, it makes a clean break from the cold runner, leaving no
tem is even an option. Due to residence time, a highly engineered sharp edges.
resin may need to be injected right into a part once it comes out of
the molding machine. If a particular material only has a short amount Selecting Nozzles
of time it can be fluid, a hot runner system might not be viable. The appropriate nozzle for a hot runner
All of the specs provided by the material supplier will ultimately system is determined by the type of mate-
determine which nozzle is selected. And knowing everything you rial going through the flow channels. If the
can about a material will help you “think like a pellet” when design- nozzle is too small, sheer is created. If it is too
ing the hot runner system for optimal operation. large, the system cannot be flushed out through
the manifold or the nozzle. Choosing nozzles
Hydraulic, Pneumatic, or Electric When choosing a nozzle, it is important to and manifolds
Hot runner equipment comes in three varieties: hydraulically pow- consider how many shots of material are in the depends on the
individual needs of
ered, pneumatically powered, and electrically powered. Whether a manifold. Typically, it is standard to have within the part.
cleanroom is required dictates which of these options is used. three shots of material between the machine
Hydraulic systems provide powerful valve gate shutoff, contrib- barrel and the part. Sometimes this changes due to high cavitation
uting to maximum part quality. However, due to the risk of oil leaks (the formation of vapor bubbles of a flowing liquid). Resin can only
and contamination, they are unsuitable for use in cleanrooms. be heated for a certain amount of time before losing its properties.
Pneumatic systems, a much cleaner option, have long been the hot Because all material has this residence time, it is important that the
runner of choice, but these also have a downside. Their relatively nozzle be small enough to constantly contain fresh material.
weak shutoff force is less than ideal for the high speeds and preci-
sion the market demands. Reusing Hot Runner Systems
Electrically powered hot runner systems are a relatively new There are situations in which a processor can use the same hot
innovation. These systems provide more power, speed, and pre- runner system for different parts that are within the gram weight
cision than pneumatic or hydraulic options. And they use power capacity of the system’s nozzles.

32 | JULY 2010

MD100702 032 32 7/2/10 9:25:49 AM
For example, a part may be 5 g, but the same nozzle can also han-
dle a part that is 10 g. If the molding is within the same limitation of
that nozzle itself, A-plates and cavities can be pulled off and placed
on other A-plates and cavities, as long as they match the capacity of
the nozzles that were chosen first. Your Single Source
Reusing hot runner systems generally requires forethought on
the part of the mold maker to design molds and part cavities that Solution for all Your
are spaced appropriately for a specific hot runner system. A mold
maker can put small cavities into a large footprint, which is an im- Custom Injection Molded
portant planning consideration.
If one part can work in a 1-in. pitch, but the other part requires Plastic Components!
a 1.5-in. pitch, the drops must be 1.5 in. apart. That way, the larger
spacing is run first, and it becomes the reference point before run- (QJLQHHULQJ 7RROLQJ
ning the smaller part. A molder can always go large to small, but
not the other way.
Tip Style Selection Š3URWRW\SH$VVLVWDQFH
Once the nozzle type is selected—which also determines the hot
runner model provided by the supplier—an OEM should select the Š0ROG%XLOGLQJ&ODVV
nozzle tip style. A variety of tips are designed for different types of Š0ROG5HSDLU 5HYLVLRQ
hot runner applications.
Sprue gate tips are used for situations in which gate vestige is
not a concern. They offer minimal flow resistance and handle most Š+LJK6SHHG+DUG0DFKLQLQJ
resins effectively. Extended styles of sprue gates provide additional Š6ZLVV6FUHZ0DFKLQLQJ
stock for machining runner profiles or part contours. Sprue gate
tips can be used with either valve gates or thermal gates, but gener-
ally go from thermal to a cold runner. They keep the sheer of the ma-
terial down until it goes into the part, which prevents plastic from ,QMHFWLRQ0ROGLQJ
degrading before it has achieved a fully fluid state.
Point gate tips are used only for thermal gate systems and are
suitable for direct part gating. They’re generally used for applica- Š,QVHUW 2YHU0ROGLQJ
tions needing optimal gate cosmetics and can run a wide range of Š)DPLO\0ROGLQJ
resins. As a general rule, point gate vestige will be one half of the
gate diameter. If a 0.04-mm gate is used, up to 0.02 mm of material
could stick up. That excess can be removed, if necessary, depending Š,62&OHDQ5RRP$VVHPEO\ 
on where it is on the part.
Through-hole tips, also used for thermal gating, have nothing in
the tip to split material molecules. Their gate vestige is equal to the Š6HYHUDO9DOXH$GGHG6HUYLFHV
gate diameter. A 0.04-mm gate will produce a 0.04-mm vestige. Š,62&HUWLÀHG
Many preforms use through-hole tips. They’re also commonly
used for parts with secondary operations, like blow molding, when
the processor doesn’t want to sheer the material and wants to mini- Š'HVLJQRI([SHULPHQW
mize gate vestige as it moves to a secondary operation.
Valve gates eliminate vestige completely, leaving only a witness line
where the part is sealed off, similar to those left by an ejector pin. This
makes valve gate tips essential for many delicate medical molding ap-
plications in which surface quality and precision are critical.

Sourcing the Manifolds

Once the nozzle type and tip style are determined, they need to
be housed in a manifold, which takes the melt from the molding
machine and distributes it evenly to each of the hot runner system
nozzles. Often, manifolds are sourced from the nozzle supplier as
part of a nozzle and manifold system due to the precision machin-
ing required. However, some mold makers may have the capabilities 
needed to do this in-house as well. 1HZ)UHHGRP3$
Manifolds are generally made of P20 or stainless steel for the


MD100702 033 33 7/2/10 9:25:54 AM

medical industry. It is crucial that they be properly extrude honed, part of the design. This is helpful if the part requires a screw hole or
a process by which flow channels are rounded and highly polished. similar element. The pin can be set to open at 0.0001-in. increments
This eliminates friction and removes any spots where materials along its 0.75-in. stroke range. All other hot runner options are ei-
could potentially get stuck or degrade. ther open or closed, without the ability to stop the pin midway.
Because extrude honing is an advanced and critical process, Besides design benefits, variable pin positioning also enables
medical molders or mold makers rarely build their own manifolds. even filling of a family mold in which one cavity may be larger than
By buying an entire hot half (defined later), or a whole system from another. Without this level of control, the mold may become out of
a manufacturer, molders know the manifolds have been extrude balance in the filling process or uneven pressure buildup may be-
honed to the highest specifications. come a problem.
The final step in creation of a hot runner system is developing Electric valve gate machines provide faster mold changeovers as
what is called a full hot half. This includes the nozzles, the manifold, well. With these systems, a molder merely hooks up the electric from
the hot runner system to the control box. Air
and hydraulic require hooking up hoses and
Given quality and contamination cables and make the process much more
considerations in molding medical time consuming.
Electric valve gate hot runner systems
products, it’s no wonder the industry also have variable speed capability, which
is moving toward electric machines. is perfect for coinjection and family molds.
This capability helps balance the mold and
the mold plate that houses the manifold so that it can fit into a mold allows for sequencing on larger parts. When the molder wants to
base system, along with all of the wiring. Again, the level of sourc- move the knit line across, the machine enables the plastic to flow
ing for a full system versus in-house development depends on the from one nozzle to the next as they open and close in sequence.
capabilities of the molder or mold maker and the best use of their Most molding requires the pins to all open or all close at the same
resources and core competencies. time within a mold. However, there are times when a molder might
want to partially open one gate while another is fully open to help
The Electric Valve Gate balance out the mold as it fills. The electric valve gate is the only
Given quality and contamination considerations in molding medi- machine that can accomplish this.
cal products, it’s no wonder the industry is moving toward electric
machines—both electric molding machines and electric valve gate Limitations of the Electric Valve Gate
hot runner systems. Hydraulic-powered hot runner systems are not Because the electric valve gate is still fairly new technology, there
an option for cleanrooms, and the cylinders in pneumatic systems may be some applications for which it is not the right solution. This
cannot match the speed or the 35,000-psi shutoff power of an elec- is often due to the 3-sq in. size of the motors that currently operate
tric valve gate. each valve gate. The measurements are somewhat large for close
Pneumatic systems have a moving solenoid, which takes time to center-to-center distances.
move. A mechanical process has to occur before the machine can That means that three pins share the same plate if a molder needs
send air to the valve gate cylinder. With the electric valve gate, it one inch of distance between pins. All of the pins have to fire at the
takes mere nanoseconds for an electric signal to fire a valve. same time. That isn’t generally a problem for small, high-quantity,
Another downside is the common maintenance and performance high-cavitation parts. But it does create limitations for larger parts
issues of pneumatic systems caused by poorly tightened air or water with multiple gates.
lines that don’t properly cool the plates. When this happens, the O-
rings can bake on the cylinders, lose their integrity, and cause air Conclusion
leaks that contaminate the parts and decrease system pressure. The benefits of hot runner technology, specifically the electric valve
Since a motor moves the cylinder on an electric valve gate, there are gate, are only getting better. The future of this technology includes
no O-rings that can dry out or that need to be maintained. faster and smaller motors. In addition, the cost of the machines is
Eliminating leaks reduces scrap as well. A fast, precise, and power- also anticipated to come down in the coming years.
ful closing force reduces the gate vestige into which scrap can enter. Hot runners are an extension of a molding machine nozzle, but
With oil or air, leaks can occur, which change the viscosity of the they offer a unique opportunity for efficiency and cost savings. They
material. The change in viscosity prevents the valve from opening or offer problem solving for complex applications.
closing all the way, creating a nub on the parts. Electric valve gate hot
runners have such a great closing force that they will close up on the Craig Kovacic is global manager of hot runner systems for DME Co.
material flow as programmed even if the viscosity of the material has (Madison Heights, MI). MT
changed. This results in better part quality and reduced scrap.
The electric valve gate and its variable pin-positioning feature can
also make design elements easier. The molder can control how far
the pin sticks out. This means it can even protrude into the product
if desired, allowing the valve pin to make a hole in the product as

34 | JULY 2010

MD100702 034 34 7/2/10 9:25:58 AM
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Molding Directory
Molding Services Micromolding Mold Tooling
Donatelle Micro
Blow Molding
PolyMedex Discovery Group Mold Toolmaking Precision Molding
Crescent Industries Inc. Minnesota Rubber and Plastics
Cleanroom Molding Donatelle Plastics One Inc.
Crescent Industries Inc. Minnesota Rubber and Plastics
Micro Plastics One Inc.
Plastics One Inc. Company Listing
Vesta Resin Molding
Plastics One Inc. Crescent Industries Inc.
Compression Molding 70 E. High St.
Vesta Rubber Molding New Freedom, PA 17349
Minnesota Rubber and Plastics 717/235-3844
Injection Molding Vesta
Crescent Industries Inc.
Donatelle Thermoplastic Molding Crescent Industries is a single-source pro-
Micro Crescent Industries Inc. vider of custom injection-molded plas-
Minnesota Rubber and Plastics Micro tic components using high-performance
Plastics One Inc. Minnesota Rubber and Plastics thermoplastics in a variety of molding
Proto Labs Inc. PolyMedex Discovery Group services. The company’s medical molding
division, Crescent Medical Plastics, oper-
Insert Molding ates in a 10,000-sq-ft cleanroom facility. It
Crescent Industries Inc. Molding Equipment has the ability to produce Class I, II, and III
Donatelle medical devices, surgical equipment, and
Micro Compression Molding disposables.
Plastics One Inc. Minnesota Rubber and Plastics
Vesta Donatelle
Injection Molding 501 County Rd. E2 Ext.
Liquid Injection Molding Micro New Brighton, MN 55112
Donatelle Minnesota Rubber and Plastics 651/633-4200
Minnesota Rubber and Plastics Plastics One Inc.
Insert Molding Donatelle helps OEMs from concept
Metal Injection Molding Micro through production. Services include
Micro Plastics One Inc. molding of engineering grade thermoplas-
tic and elastomeric materials, micromold-
ing, liquid silicone injection molding, insert

36 | JULY 2010

MD100702 036 36 7/2/10 4:27:38 PM

molding, and overmolding. The company’s Canon Trade Events ...............................30, 35
facilities house more than 40 molding ma- PolyMedex Discovery Group serves medi- 310/445-4200 •
chines ranging from 5- to 300-tn capacity. cal device manufacturers with comprehen-
The company is FDA compliant as well as sive development and manufacturing ser-
ISO 9001 and 13485 certified. vices for intravascular, minimally invasive,
and implantable applications. It supports Crescent Industries Inc...............................33
Micro its customers with polymer distribution, 717/235-3844 •
140 Belmont Dr. custom compounds, bioresorbable and
Somerset, NJ 08873 drug delivery formulations, thermoplas-
732/302-0800 tic and thermoset tubing, and custom Donatelle .......................................................... 7 components. 651/633-4200 •
Micro is a full-service contract manufac- Proto Labs Inc.
turer of precision medical devices and 5540 Pioneer Creek Dr. Foster Printing ...............................................25
components, injection and insert mold- Maple Plain, MN 55359 866/879-9144 •
ings, and fabricated tube assemblies. It 877/479-3680
offers product development and design
capabilitie from prototyping and validation Medical Extrusion Technologies Inc. .....11
to full-scale production. The company’s Proto Labs through its First Cut and Proto- 800/618-4346 •
modern facilities are ISO 9001, ISO 13485, mold services uses proprietary computing
and ISO 14001 certified. Micro maintains technologies and automated manufactur-
an ISO Class 8 cleanroom for surgical in- ing systems to provide prototype parts and Plastics One Inc............................................25
strument assemblies. short-run production services. All compo- 540/772-7950 •
nents are made by standard production
Minnesota Rubber and Plastics methods and can be shipped in as fast as
1100 Xenium Lane N. one day. PolyMedex Discovery Group ....................15
Minneapolis, MN 55441 860/774-1559 •
952/927-1455 Vesta 5400 W. Franklin Dr. Franklin, WI 53132
Minnesota Rubber and Plastics is a custom 414/423-0550 Proto Labs Inc.................................................. 3
molder of components and assemblies, 877/479-3680 •
specializing in high-performance materi-
als. Services include product development, Vesta is a manufacturing services com-
tool design and fabrication, prototyping, pany that provides molding, extrusion, and Saint-Gobain Performance Plastics ........19
insert molding, silicone overmolding, as- assembly for the medical device industry. 800/236-7600 •
sembly, and Class 10,000 and 100,000 clean- The company provides expertise in design
rooms and packaging. assistance, material selection, and quality
standards within ISO-certified facilities. It
Plastics One Inc. offers a range of molding capabilities in- Sil-Pro (Silicone Professionals) ................. 5
6591 Merriman Rd. cluding liquid injection, transfer, and insert 763/972-9206 •
Roanoke, VA 24018 molding of medical-grade silicone. 2
540/772-7950 Smiths Medical OEM .................................... 9 Look for the following upcoming 866/216-8808 •
Plastics One specializes in custom injection directories in MD+DI:
molding of medical device components
with complex requirements and unique ■ Who’s Who in Contract Manufacturing
specifications. It provides a range of servic- ■ Outsourcing Showcase* Vesta Inc. ........................................................23
es including design and research, in-house ■ Packaging and Sterilization Showcase* 414/423-0550 •
tooling, prototyping, and assembly. ■ LitPak*

PolyMedex Discovery Group *advertisers only Wacker Chemical Corp...............................27

45 Ridge Rd. 888/922-5374 •
Putnam, CT 06260 Contact your local sales representative to
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MD100702 037 37 7/2/10 4:26:22 PM