In This Issue

Mission-Critical Equipment Positive Material Identification (PMI): Intepreting Results Dilbert Contest Calendar

Mission-Critical Equipment
What You Should Expect from Your Aseptic Components

CONTEST Deadleg Killer Valve Name it and win an iPad 2!

We need a fantastic name for our spiffy new satallite valve. Come up with the perfect name, and win an iPad 2! Go here to enter: http://www.asepco.com/ news/2011/04/killer-app-satellite/

For many of you, the phrase missioncritical components might conjure up an image of the gold foil-covered shields found on space satellites or the mil spec parts found in an F-16. But in truth, you are using mission-critical components in your facility right now. In our industry, the combination of product value along with the risk of product compromise through contamination definitely requires a get-it-right-the-firsttime mentality. But is your equipment designed to live up to these demands? Does it help you meet your quality and production goals, or does it get in your way? ASEPCO defines mission-critical-level aseptic components as those that provide extremely consistent performance and delivery of vital functionality in an application where downtime and product loss attributable to equipment failure cannot be tolerated. So, what should your equipment be able to do if its designed for mission-critical use? We offer the following list of missioncritical characteristics as a measuring stick against which to evaluate all your aseptic components: Proper operation is easy to implement.
Continued on page 3

Positive Material Identification (PMI): Interpreting Results

by Paul L. Sturgill, Sturgill Welding & Code Consulting

Word of the Month

Repartee Pronunciation: (rep-er-tee, tey, -ahr-) Meaning: (noun) 1. A quick, witty reply. 2. Conversation full of such replies. 3. Skill in making such replies. Sentence - We engaged in witty repartee about our Dilbert cartoon.

In any biopharmaceutical application, material specifications are a critical component to the success of the project. Engineering firms specify the materials that must be used based on the process conditions those materials will be exposed to during processing. Vendors like ASEPCO provide products that conform to these specifications. When the products are received, end users must verify that the products conform to the specifications. Positive Material Identification (PMI) is one of the nondestructive techniques used verify material conformance. At Sturgill Welding & Code Consulting, we find that PMI results are sometimes misinterpreted, which can cause project delays and other issues. So, we thought it
Continued on page 2

Does Your Valve Perform Like a Superhero? Introducing the 1/2 Compact Inline Valve.

Dilbert

More info here: http://www.asepco.com/ news/2010/12/killer-app-compact-inline/

2011 ASEPCO Corporation. All rights reserved.

Fun and Games Quote of the Month

If you could choose one characteristic that would get you through life, choose a sense of humor. ~Jennifer Jones~

Positive Material Identification: Interpreting Results

...continued from page 1

might be useful to briefly discuss what PMI is, the equipment that is used to perform PMI, and how to evaluate the results produced by the testing equipment. Various techniques are used to determine the chemical composition of metallic engineering alloys, ranging from laboratory methods that can identify all of the elements (including interstitial elements such as carbon and sulfur) to employing portable units that can determine only a limited number of alloying elements. Positive Material Identification (PMI) is one of these techniques. For this discussion, we focus on the portable hand-held units commonly used in the biopharmaceutical industry for alloy verification. These units can operate in two modes: They can either provide data as a discreet list of alloying elements and their amounts, or they can identify an alloy by comparing the compositional data obtained against a list of alloys whose partial nominal compositions are stored in the units memory. This report explains that the most reasonable way to use PMI data is to compare both the discreet list of alloying elements determined by PMI and the interstitial elements listed on the MTR with the requirements of the material specification to which the material was purchased.

Brain Teaser
Heart of Darkness, Coat of Grain, Was once alive, Now feels no pain, Never walks, but Leaves a Trail. Circle head and pointed tail. Grows shorter as the day goes onIts waistline is a hexagon. What am I? Answer on page 4.

A PMI unit identifies an alloy based upon the alloy library in the PMI units memory. This data is based on a wide range of specifications and sources including American Society for Testing and Materials (ASTM), Society for Automotive Engineers (SAE), American Iron and Steel Institute (AISI), and trademarked manufacturers such as Haynes, Carpenter, and Allegheny Ludlum (which make and patent certain alloys). This data might be unrelated to the specifications to which the material or equipment in question was ordered. In addition, the PMI unit might identify a material as a specific alloy if its composition is close to that of an alloy in the PMI units library, not because it actually meets a set of criteria. Portable X-ray fluorescence (XRF) technology cannot detect elements whose atomic numbers are less than 22 (which corresponds to titanium), so important elements such as carbon, sulfur, silicon, and phosphorus cannot be detected. However, material specifications that govern materials of construction for our industry specify ranges for these elements. As a result, PMI data, by definition, cannot be used to determine an exact match to any ASTM or ASME material specification. For this reason, a PMI units display reading that an alloy matches a 316 stainless steel composition cannot be used as proof that the alloy meets a material specification requirement. Only the material specification and alloy grade requirement on the contract document is enforceable, not the PMI units statement that an alloy is a match.
Applicable Standards and Specifications

Jokes Job Interview Techniques

Take the prospective employees you are trying to place and put them in a room with only a table and two chairs. Leave them alone for two hours, without any instruction. At the end of that time, go back and see what they are doing. If they have taken the table apart, put them in Engineering. If they are counting the butts in the ashtray, assign them to Finance. If they are waving their arms and talking out loud, send them to Consulting. If they are talking to the chairs, Personnel is a good spot for them. If they are wearing green sunglasses and need a haircut, Computer Information Systems is their niche. If the room has a sweaty odor, perhaps theyre destined for the Help Desk. If they mention what a good price we got for the table and chairs, put them into Purchasing. If they mention that hardwood furniture DOES NOT come from rainforests, Public Relations would suit them well. If they are sleeping, they are Management material. If they are writing up the experience, send them to the Technical Documents team. If they dont even look up when you enter the room, assign them to Security. If they try to tell you its not as bad as it looks, send them to Marketing.

Background

The raw data collected by PMI units is the X-ray spectra that plots the intensity of outer shell electron decay as a function of the characteristic energy level (wavelength) for each element detected. PMI units convert these spectra to lists of alloying elements and their amounts. These units usually have built-in alloy grade libraries that list partial composition ranges for many commercial alloys.

Vendors and equipment fabricators build equipment based on written instructions from engineering firms or end users. These instructions are usually in the form of a purchase order or a bill of materials (BOM), which is included in the drawing package of requirements for a piece of equipment. The construction material is identified by two pieces of information: the material specification and the alloy grade or designation.
Material Specifications

The material specification is one of a number of common ASTM, ASME, or foreign specifications that list different alloy grades of a single product form or for a single intended use. Typical specifications include: A240/SA-240 for plate, sheet, and strip
Continued on page 3

2011 ASEPCO Corporation. All rights reserved.

The Jokes Keep Coming... Engineering Marketing Hype Translated

(From: nipperchipper (nipperchipper@ hotmail.com)) ALL NEW: Parts not interchangeable with previous design. ADVANCED DESIGN: Nobody understands it. YEARS OF DEVELOPMENT: We finally got one that works. REVOLUTIONARY: Its different from our competitors. ALL SOLID-STATE: Heavy as Hell! UNPRECEDENTED PERFORMANCE: Nothing we ever had before worked THIS way.

Mission-Critical Equipment (continued)

...continued from page 1

It is difficult to make components fail (at ASEPCO we call this bomb-proofed design). The basic design requires very little training for operation.

All components conform to relevant manufacturing standards (such as ANSI, ASME, BPE, CE, and CFR). Traceability is provided (certificates on steel, fittings, and diaphragms, and heat numbers on welded sub-components). Maintenance instructions are simple and are sent with every order. Delivery is fast, accurate, and on time. At ASEPCO, we have structured our manufacturing processes and designed our components (valves, mixers, vessel connectors, etc.) to meet these missioncritical component characteristics. And, we hope that by promising to comply with this list, you will make us your preferred provider of aseptic processing components.

You might be an engineer if

... you only get jokes through email. ... Dilbert is your hero. ... you can quote the scenes from any Monty Python movie. ... you talk about trellis code modulation at parties. ... your favorite character on Gilligans Island was The Professor. ... you laugh at jokes about mathematicians. ... the Humane Society has you arrested because you actually performed the Schrodingers Cat experiment. ... the fun center in your brain has deteriorated from lack of use.

Components are easily and quickly validated. CIP/SIP cycle times are short. Component manufacturing methods eliminate defects inherent in the production process (such as the pits and cracks found in cast valves vs. those manufactured from bar stock).

Over the years, youve come to expect the highest design quality from ASEPCO. Thats why our tank valves are some of the most frequently used valves in critical applications. Now you can add inline valves, vessel connectors, and magnetic mixers to that list. See http://www.asepco.com/news/missioncritical/ for the online version of this article.

Positive Material Identification: Interpreting Results (continued)

...continued from page 3 Alloy Grade/Designation

Our Last Contest and the Winner is...

In March, everybody was a winner! We gave away nearly 200 bottles of great California wine at Interphex and in our March wine drawing. Cheers!

Smaller, lighter, and easier on the wallet! ASEPCOs 1.5 Tank Outlet Valves.

for pressure vessels (heads and shells of vessels are usually made from plate products produced to this specification) A249/SA-249 for welded austenitic steel heat exchanger tubing A213/SA-213 for seamless austenitic steel heat exchanger tubing A484/SA-484 for stainless steel bars, billets, and forgings A351/SA-351 for stainless steel castings for pressure containing parts A182/SA-182 for forged or rolled alloy steel pipe flanges, forged fittings, and valves and parts for high-temperature service Each of these specifications lists a number of alloy grades. In fact, each has a listing for the chemical compositional requirements for 316L stainless steel. This list of elements and their compositional ranges is identical in some specifications, but might have different ranges for certain elements in others. So, to evaluate any set of PMI readings, both the alloy grade and the material specification are needed for every piece tested.

The alloy grade is an informal description that can be manufacturer specific, such as Hastelloy C276, or it can be more generic, using the Unified Numbering System (UNS) for Alloy 276, UNS N10276. The UNS number is the industry standard for alloy grade or designation. As an example, AL-6XN is a 6% molybdenum alloy manufactured by Allegheny Ludlum. Originally, this alloy was made and patented by Allegheny Ludlum, and the specific alloy name, AL-6XN, is a registered trademark of Allegheny Ludlum. The patent on this alloy has expired and a number of manufacturers now make this alloy. As a result, the more generic name for this alloy is UNS N08367. So, AL-6XN is not an alloy grade; it is a trade name and specifies UNS N08367 made by Allegheny Ludlum.
PMI Accuracy

Learn more here: http://www.asepco. com/news/2011/02/killer-app-new-1-5tank-outlet-valve/

The accuracy of compositional data produced by PMI units must be evaluated prior to comparing the data to any standard for acceptance. One factor that affects accuracy
Continued on page 4

2011 ASEPCO Corporation. All rights reserved.

Calendar
May 11, 2011 BioTech 2011 Boca Raton, FL http://www.biospace.com/calendar_ event_details.aspx?CalendarEventEntity Id=691413 May 30-31, 2011 Interphex Singapore Conference SUNTEC, Singapore http://www.interphexasia.com/ June 13-16, 2011 NSTI Nanotech Conference Boston, MA http://www.nsti.org/Nanotech2011/ June 27-30, 2011 Bio International Convention Washington, D.C. http://convention.bio.org/ August 8-9, 2011 BioProcessing Facilities 2011 San Diego, CA http://www.tradelineinc.com/conferences/ DDF52B3B-F4CA-1FA4-3D1D00DF53A7B347 September 7-9, 2011 BioPharm America 2011 Boston, MA http://www.ebdgroup.com/bpa/index.php October 20-21, 2011 Interphex Puerto Rico San Juan, Puerto Rico http://www.interphexpuertorico.com/

Positive Material Identification: Interpreting Results (continued)

...continued from page 3

is exposure time; that is, the time that the detector in the PMI unit is receiving energy from the decay of the excited electrons in the material The typical minimum exposure time for accurate readings is 30 seconds, and the longer the exposure time, the more accurate the reading. Some of the older gamma-ray source units require the operator to depress and hold the trigger manually for the full exposure time to keep the shutter open. Inaccurate readings obtained on the older units can be due to single pulse depressions of the trigger, which result in only momentary X-ray exposure, and, as a result, incomplete data. The newer units automatically hold the shutter open for the necessary exposure time without the operator having to hold the trigger. In addition, the data output usually has a header of Element +/- Prec. This reflects the accuracy tolerance in wt. % of the reading indicated on the display of the PMI unit. If the reading is 58.21 +/- 0.86, the real reading is anywhere between 57.35 and 59.07. As a result, this precision tolerance must be added to and subtracted from the displayed value to see if the range produced generates a value within the acceptance range in the appropriate ASTM material specification.
Product Analysis Tolerance

product analysis tolerance of +/- 0.15 wt. % results in an acceptable range for PMI data for molybdenum of 12.35 to 14.65 wt. %. For product analysis tolerances, ASTM B880 is the secondary specification found in several ASTM specifications for nickelbased products. ASTM B751 contains the product analysis tolerances for nickel-based tubing, including AL-6XN as listed in ASTM B676. For the purposes of evaluating PMI data, these product analysis tolerances, along with the precision tolerance of the PMI unit being used, must be considered together to determine acceptability of the PMI data.
Meeting the Molybdenum Range

Answer to Brain Teaser:

Pencil

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If the PMI unit reports a range outside the compositional range listed in the appropriate material specification, do not automatically reject the material. Domestic material specifications list compositional ranges for the elements in a given alloy. The material purchaser is allowed to perform a product analysis to verify the identity of the furnished material; PMI is a form of this product analysis. The material specification lists the tolerance that can be applied to such product analysis, or states that the product tolerances are found in some other material specification, referred to in this report as secondary specifications. This is the amount by which the product analysis, when requested by the purchaser, can be either over the maximum or under the minimum limit and still be acceptable. These tolerances are a function of the nominal amount of the specific alloying element in the material and increase as the amount of the element in the alloy increases. For instance, for nominal specified molybdenum contents between 7 15 wt. %, the product analysis tolerance is +/- 0.15 wt. % (in some specifications). So, for UNS N06022, having a specified molybdenum range of 12.5 to 14.5 wt. %, the

Bear in mind that the amount of molybdenum present in N06022 (or any other molybdenumbearing alloy) will not be in the middle of the specification range of 12.5 14.5 wt. % for this alloy. To minimize the cost of the alloy, the amount added by producers is typically the smallest amount required to meet the specification range (12.50 to 12.70 wt. %). As a result, the PMI data generated on these higher alloys can result in some data that is under the low limit for the important and expensive alloying elements, such as molybdenum or nickel. This underscores the importance of understanding how to use the product analysis tolerance values in conjunction with PMI precision to evaluate marginal alloy PMI data. In addition, because the hand-held PMI units cannot determine carbon, silicon, sulfur, and phosphorus, PMI data must be used with the data on the MTR to determine compliance to a material specification and to the alloy requirements of the user specification.
Summary

Sturgill Welding & Code Consulting recommends that PMI data be used in conjunction with the interstitial element data on the MTR to determine material compliance to a specification. Those operating the PMI unit must be trained individuals who ensure that each reading is the result of a full exposure cycle. Operators must apply the appropriate product analysis tolerance and precision tolerance to each reading before evaluation. Remeasuring to obtain an acceptable or unacceptable result is NOT permissible for acquiring and evaluating PMI data. See http://www.asepco.com/news/pmiinterpreting-results/ for the online version of this article.

2011 ASEPCO Corporation. All rights reserved.