Production of solid drugs

Tablets

Capsules

Sachets

Consulting
+ Design
+ Engineering
+ Supply
+ Installation
+ Commissioning
+ Qualification
+ Instruction and training
+ Support and service
= Integrated solutions from one source

We s e t t h e s t a n d a r d
 Yo u h a v e a t a r g e t

L au nch ing
new products
more rapidly.
Improving
competitiveness via
ef f icient processes.

Re-engineering - an economic reform

process that the pharmaceutical
industry cannot ignore.
The aim is to maintain and improve
competitiveness.
In order to save costs while rapidly
launching an ever increasing variety
of products, often only in small
quantities, you need to do more than
just replace outdated machinery.
Therefore, integrated strategies are
required.

Before we speak about

equipment ...

What kind of products do you want

to produce?
Which forms of packaging?
In which timeframe?
What are the framework conditions
for a project in order to make it a
success?
There seem to be many cost-effec-
tive solutions – at a first glance.
However, if you set great importance
on quality, performance, functiona-
lity, flexibility, latest state of the art
technology, and efficiency in the
long-term, you will need a partner
who provides the best solution
– your partner is Glatt.
• A partner who develops the • A partner who sets the course for
bases for your decisions. a successful project.
• A partner who takes on the
project’s responsibilities.
• A partner who supervises the
interfaces between the individual
project phases and thereby
ensures smooth procedures. You w a nt su c c ess?
• A partner who is a drug producer
and machinery manufacturer G l a t t i s y o u r p a r t n e r.
himself.
• A partner who integrates Tell us your targets -
machinery in an enterprise We w i l l h e l p y o u
management system. realize t hem.

2
 We pave t he way
Why we can do t his.
How we can do t his.
A company with expertise
and experience
To make a project a success story
you need a feasible concept. Glatt
provides creative solutions, innovative
methods, advanced expert know-
ledge, and a professional project
management - from the first idea to
the implementation of your prod uc-
tion. We are able to do this because
we can rely on many years of expe-
rience in engineering and installation
of turnkey production facilities and
approved production plants in the
pharmaceutical industry.
Moreover, as we incorporate and
coordinate all the partners and sub-
contractors, there is only one single
contact person for your entire project.
This provides you with a sound basis
for the success of your investment.
A company with an extensive
service portfolio
Regardless of whether a new instal-
lation, extension or modernization/
GMP upgrading, individual compo-
nents, complex production lines, or
complete production facilities - we
design, engineer, and implement
high-performance and reliable pro-
duction processes for solid, sterile,
and other non-sterile drugs.
Our experts are team workers.
They
• conduct location and efficiency
analyses,
• engineer processes and plants,
• submit proposals for process
optimization,
• create financing concepts,
• integrate equipment in existing
buildings, machinery, and
computer environments,
• engineer and specify all the details,
• manufacture equipment
components in Glatt’s own
manufacturing facilities,
• supervise construction sites,
• coordinate deliveries,
• install and commission plants,
• qualifcation of equipment and
plants according to current GMP
regulations of the EU and US as
necessary,
• provide reliable service.
3
A company with worldwide
activities
At present, the Glatt Group employs
approx. 1,500 employees in more
than 20 companies worldwide.
Numerous representative offices
are at your worldwide disposal, and
offer Glatt's complete range of
services.
This means: reliability, financial
security, and worldwide service for
your projects.
Before we move on to the
machinery...
Who does everything, often does
nothing properly. That is why we
focus on things that we are expe-
rienced in. This is the reason why
Glatt's machines and plants are
leading products. For all other
applications, we obtain the best
technologies on the market for you
and integrate them into a functional
plant network.
You obtain long-lasting system com-
patibility of plants and components,
spare parts, training, and much
more – in short: exactly what you
need, from one source.
 GMP standard all along the line

State of t he ar t
technology.
F ro m raw mater ial
receiving to dr ugs
ready to dispatch.

Glatt designs the processes and

systems, as well as supplies and
integrates the machines and equip-
ment for all solid drug production
processes.

1 Raw material receiving and

sampling

2 Weighing & dispensing (p. 5)

3 Granulation & pelletizing (p. 6)

7 8

5 4 Forming (p. 8)

5 Coating (p. 8)
4
6 Quality control (p. 8)
4
7 Product handling (p. 10)
7
4
6 8 Packaging, storage and material
transport (p. 11)

7 Utility systems (p. 12)

7

Regardless of which solid

dosage forms you intend
to produce, whether you
want tablets, capsules,
1
2 sachets and f inal
packaging - we guarantee
the highest ef f iciency
and product q uality.
Material flow in a layout for tablet production

4
 Weighing & dispensing

Weigh ing.
Dis pens ing .
Documentation.
Safe recipes fo r
your success.

When designing, engineering, and

implementing systems for raw
material dispensing we fully consider
your specific requirements for sizing
and design.
Automatic bulk ingredient weighing

Our offer You benefit from

Complete handling systems, but also
separate components and process
modules for the precise dispensing
of all active ingredients and raw
materials. Containment level con-
cepts depending on occupational
exposure level (OEL).
• Raw material preparation
(sieving, milling)
• Dispensing of bulk ingredients,
e.g. from big-bags, sacks, and
drums
• Accurate, clean, and reproducible
dosing of small quantities
• Dispensing of solid, semi-solid, or
liquid raw materials, batch or raw
material oriented
• Single-component or cumulative
weighing into intermediate
containers or directly into process
containers
• Raw material identification, raw
material control, recipe and
residue management
• Electronic data management and
documentation, as well as the
transmission of weighing data to
SCADA systems
• High productivity thanks to short
weighing cycles and optimized
container handling
• Flexible batch preparation
• Exact dosing for large, medium,
and small quantities, manually or
from drums, containers, or silos
• Absolutely strict separation of raw
materials
• Support of process and cleaning
validation

Direct dispensing of bulk ingredients from sacks, big-bags, and containers Feed for small drums

5
 Granulation & pelletizing

Mixing.
Granulating.
Pelletizing.
Dr y ing.
F ro m t h e e x p e r t o f
integ rated process
technology.

Benefit from the comprehensive

expertise of the market leader for
granulation, pelletizing, and drying
systems in the pharmaceutical
industry.

Production of granulates or pellets,

or both?
Use of organic solvents?
Total containment?
Fluid bed or wet granulation with
subsequent fluid bed drying?
Single-pot technology?
System layout on a single level or
over several levels?
Product transfer without filling in
intermediate containers?
We show you the alternatives and
implement the variant that is
optimal for you.

Our offer
Quality and expertise from more
than 50 years of experience in
manufacturing plants for gentle
product handling via flexible and
efficient processes:

• Fluid bed plants for drying,

granulating, and pelletizing
• High shear mixers, also with
integrated drying
• Sieves, spheronizers

Fluid bed granulation with the Glatt WSG

6
 Granulation & pelletizing

• Complete granulation lines, and if

required, with completely closed
product transfer
• Pressure shock proof up to 12 bar
in closed systems for the maximum
explosion protection at a mini-
mized weight
• Options for solvent recovery
• Innovative product handling
systems, e.g. for product transfer,
pneumatically or by gravity
• Fully automatic validatible CIP
processes, e.g. with patented Glatt
SC SuperClean© technology
• Fully automatic validated process
control systems (PLC or PC
controls) as stand-alone solution
or with an interface for a network
connection to management sys-
tems such as SAP

You benefit from

• Use of state of the art technology
• Gentle product handling
• Highly reproducible product quality
• Maximum pharmaceutical safety Wet granulation in the Glatt Vertical Granulator
• Intelligent user-friendly process
control
• High efficiency thanks to the
integrated optimized sequences

Fast efficient wet mixing (e.g. Glatt Vertical

Granulator) with subsequent gentle drying in
the fluid bed system (e.g. Glatt fluid bed drier)

... with horizontal product flow ... with vertical product flow Discharge from a Glatt fluid bed drier

7
 Forming, coating and q uality control

Tabletting. Capsule
f il l ing. F il m c o a t i n g .
Sugar coating.
Pe r fe c t i n s h a p e w i t h
a f u nctio na l a n d/ o r
protective layer.

Stipulate the requirements your

products have to meet. We create the
appropriate production conditions
for you with everything necessary.
We will design, engineer, and install
From the tablet press to the coater with horizontal (left) or vertical (right) product flow
the optimal combination regarding
equipment, material handling, and
process environment, including all
the required laboratories for
microbiological and analytical quality
control.

Compounding system for coating solutions

Our offer
• High-quality compounding
systems for coating liquids
• State of the art drum and fluid
bed coaters in a modular design
for uniform coating via film and
sugar coating processes
• High-performance tablet presses
that can be quickly adapted for a
great variety of shapes for single
or multi-layer tablets
• NC controlled modular capsule
fillers for high-accuracy dosing of
Tablet press charging via a Glatt lifting column

8
 Forming, coating and q uality control

powder, pellets, herbs and micro-

tablets
• Options for solvent recovery
• Innovative product handling
systems that are based on buil-
ding level concepts: e.g., product
transfer by means of gravity for
charging from the level above
and/or discharging to the level
below
• Fully automatic PLC control
systems as stand-alone system or
with an interface for integration
in a management system such as
SAP
• Analytical laboratories including
all analytical equipment

Glatt Coater GC Master for film and sugar coating

Analytical laboratory Analytical laboratory

You benefit from

• Gentle product handling
• Highly reproducible product quality
• Maximum pharmaceutical safety
• Product-dependent containment
levels up to an isolator
• Intelligent user-friendly process
control
• High efficiency thanks to optimized
sequences
• High machine availability

Analytical laboratory

9
 Product handling

Lifting. Tilting.
Weigh ing. D o s i n g .
C o nv e y i n g .
Blending. Swivelling.
Do ck ing. F i lli n g .
Discharging.
Cleaning. Stor ing.
Documentation.

Horizontal product flow in a single-

level concept or vertical product
transfer by means of gravity in a multi-
level concept?
High containment level?
When designing and engineering
individual handling processes the
basic process layout is a crucial
point.
We develop functional, efficient, and
GMP-complaint concepts – from
dispensing to packaging.
Our offer
A comprehensive portfolio of
integrated system components - from
a simple lifting column to a fully
automatic production facility:
Multi-level concept: Process plants and handling systems with vertical product flow
• Stainless steel containers in a
variety of shapes and sizes
• Stationary and mobile lifting
columns for drum and container
discharge
• Human driverless transport
systems - HDV
• Drum and container blenders
• Modular systems with special
docking units for low-contami-
• Plants for cleaning solution
preparation
• Advanced data management and
documentation systems for the
automatic acquisition and evalua-
tion of all the relevant process
data (e. g. barcode, Mobby...)
You benefit from
• High flexibility for quick product
changes and for swift implementa-
tion of different process variants
• Safe, low-contamination handling
• Easy operation
• High efficiency thanks to optimized
smooth sequences

Container blender

nation charging and emptying

(e.g. Glatt containment valve)
• Accurate dispensing and dosing
systems
• Vacuum conveying systems for
product transfer
• Container cleaning systems
Automated dispensing system on a driverless Vibration dosing sieve
transport system

10
Packaging, storage and transport

Packaging.
Ins pecting .
L ab el l ing.
Palletizing. Stor ing.
C o ns ignme n t i n g .
T rans po r t.
Documentation. 3D storage engineering

Efficiency and flexibility are also

crucial when it comes to material
handling. Great rationalization
potentials are to be found in the
production logistics field, such as
just-in-time, pull principle, Kanban
control, etc.
We develop a functional concept to
ensure that your products are safely
packaged and quickly marketed.
Transport and feeding of the packa-
ging material from a second level?
100% in-line monitoring?
In-line printing?
White Lines?
Automatic material consumption
control?
Line-oriented organization?
We assist you with your selection in
view of the various alternatives!
Bottle filling
Our offer
The design of GMP-compliant, perfor-
mance-optimized, and flexible packa-
ging, storage, and transport logistics.
• Filling and packaging lines for
any dosage forms and packaging
materials, being flexible
High rack storage
for quick format change, semi-
automated or computer-controlled
• Packaging robots and complete
secondary packaging lines
• Pallet and small parts storage
facilities - manually operated or
automated
• Combinations of rack and convey-
ance equipment that are fully
compatible
• Mobile and fixed terminals for
paperless order picking, reple-
nishment control, and material
flow control by radio data trans-
mission or infrared technology
• Central control and integration
in IT-systems using open software
standards with defined interfaces
Filling from Big-Bags
You benefit from
• Minimized operator intervention
and error elimination by extensive
automation
• Precicely predictable production
and lead times
• Minimized stock and supplies
storage by advanced production
logistics and thereby a reduction
of intermediate storage and
material buffers
• Optimized transport routes that
reduce lead times
• Optimal use of storage areas
• High turnover rate

11
 Utility systems

Cleanrooms. Wa ter.
Air -co nd iti o n i n g a n d
Ventil atio n .
Compressed air.
Cleaning Sy stems.
Electric power
supply. Control
technology. IT.

The so-called utility systems, as we

see them, are not secondary.
You will obtain a solution that is
tailored to your company require- Changing room
ments, for all relevant areas.

Our offer
Engineering and delivery of all sup-
port processes in pharmaceutical
production, integration of efficiently
high-per-formance, professionally
designed and consumption-
optimized supply services and
disposal systems.

• Floors, ceilings, walls, and

complete accessories for all
cleanliness classes

• Air-conditioning and ventilation Cleanroom corridor

for general areas up to aseptic

cleanroom systems

• Systems for dust extraction

• Systems for the preparation and

distribution of potable hot and cold
water, purified water, WFI, pure
steam

• Systems for compressed air

generation and distribution

• CIP/SIP systems designed to

clean process related systems
Cleanroom wash place

12
 Utility systems

• Systems for wastewater treatment

according to the required envi-
ronmental bylaws

• Electric power (high- and low-

tension distribution, incorporation
of all process and secondary sys-
tems, and fire detection facilities)

• Complete packages for control and

information systems that are tailo-
red to your individual specifications

• Energy-saving programs Air-conditioning and ventilation

CIP station Chiller

You benefit from

• Cost-optimized complete
cleanroom solutions
• Reliable supply with all the relevant
media for production and auxiliary
processes
• Secure management to control,
monitor, and evaluate all the
process data items
• Integrated solutions developed
on the basis of your company’s
infrastructure
• Minimizing of operating costs
Water treatment

13
 Services and support

C o ns u l ting . D e s i g n .
E ngineer in g .
Coordination.
Installation.
C o mm is s io n i n g .
Qu al if icati o n .
Instructing.
S u ppo r ting .

A machine is not an island.

Statements on principal feasibility,
interface definitions, proposals for
system integration, alternative solu-
tions and the evaluation of results are
necessary.
Detailed information, clearly
documented – the required basis
for your investment.
Survey
Our offer
Competent backing from the first
concept to the hand over of a qualified
factory and thereafter.
• Engineering and specification of
all the details for plants, equipment,
information technology and buil-
ding utility systems, rooms and
buildings
• Tender documents
• Assembly and installation of all
process systems, technical
media, and pipelines
• Complete plant qualification, DQ,
IQ, OQ (test reports, trial runs,
documentation and calibration),
also in retrospect
• Support for your process validation
by providing validation documents
and individual consultation
• Complete documentation of all
systems, taking into account the
current guidelines
• Entire engineering package or as
turnkey project with competence
in all works and services
• Co-ordination of all subcontractors
• Cost and schedule control
throughout the project’s duration
• Support in product development in
our own technology centres
• Authorized contract production up
to the start of your own production,
for niche products or clinical
samples or launch batches
• Reliable service in all points:
quick spare parts service, regular
maintenance, and inspection

• Assessment and definition of

opportunities for cost saving
and optimization
• Feasibility studies and alter-
native concepts for processes,
plant and utility systems,
material and personnel flow,
and GMP compliance
Process control diagram - granulation process
• Supervision and support during the
commissioning of your plants, inclu-
ding the instruction and training of
your operating and service person-
nel, at your or our premises

Calibration

14
 Yo u r b e n e f i t s
Ef f icient processes.
F uture-or iented
technology.
High-quality products.
Fle xibility. Safety.
T i m e to Market.
The success of your investment
depends on a variety of factors. High-
performance and efficient processes
play a crucial role.
• A future-oriented production must
have fast and intelligently control-
led processes within a flexible
plant system network with
functional system interfaces.
This is possible with Glatt as your
partner.
Closed product flow in the granulation line
• A future-oriented production must
offer the highest product quality
for various recipes and packa-
ging forms.
This is possible with Glatt as your
partner.
• A future-oriented production must
ensure reproducible processes
with high plant availability and
short process lead times.
This is possible with Glatt as your
partner.
15
• A future-oriented production must
ensure the maximum pharma-
ceutical safety for operators,
product, machinery and environ-
ment, even if high potent products
are handled.
This is possible with Glatt as your
partner.
• A future-oriented production must
be GMP-compilant and meet any
bylaws, regulations and standards.
This is possible with Glatt as your
partner.
• A future-oriented production must
ensure a quick market support and
highest competitiveness in quality
and cost to secure the location of
your facility.
This is possible with Glatt as your
partner.
M a ke t h e r igh t
strategic decision.
T h i s o f fe r i s y o u r
ticket to a future-
or iented production.
Trust in Glatt.
 Glatt Engineering

Inter national located:

© Glatt Ingenieurtechnik GmbH – Herstellung fester Arzneimittel – 05-2009 – E-1000 – Druckhaus „Thomas Müntzer“ WE – trommer.produkt+grafik.ef
Germany
Glatt Ingenieurtechnik GmbH
Nordenstadter Str. 36
65207 Wiesbaden/Germany
Phone: +49 611 89069-7
Fax: +49 611 89069-88
eMail: info@glatt-wiesbaden.de

Russia
Glatt Ingenieurtechnik GmbH
ул. Обручева, 23 - корп. 3
117630 Москва/Россия
Phone: +7 495 78742-89
Fax: +7 495 78742-91
eMail: info.glatt-moscow@mastertelecom.ru

India
Glatt (India) Pharma Engineering Pvt. Ltd.
13 Ground Floor Palam Marg, Vasant Vihar
New Delhi – 110057/India
Headquarter Phone: +91 11 46052960
Fax: +91 11 46052964
Glatt Ingenieurtechnik GmbH eMail: info@glatt-india.com

Nordstraße 12 Switzerland
Pharmatronic AG
99427 Weimar/Germany Hohenrainstraße 10
Phone: +49 3643 47-0 4133 Pratteln/Switzerland
Phone: +41 61 826-9726
Fax: +49 3643 47-1231 Fax: +41 61 826-9727
eMail: info@pharmatronic.ch
eMail: info@glatt-weimar.de
Italy
pgs engineering s.r.l.
Via F. De Lemene, 8
20151 Milan/Italy
Phone: +39 02 3349-1015
Fax: +39 02 3349-0270
F i r s t a d d r e s s e s fo r f i r s t - c l a s s s e r v i c e s . eMail: info@pgs-engineering.it

We of fer more t han process eq uipment. USA

Ramsey Design Group
We provide integ rated solutions. (Division of Glatt Air Techniques Inc.)
20, Spear Road, Ramsey, NJ 07446/USA
Phone: +1 201 825-1391
Fax: +1 201 825-0389
eMail: info@ramseydesign.com

www.glatt.com

We set
the standard