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just replace outdated machinery.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 • A partner who develops the • A partner who sets the course for
for a project in order to make it a bases for your decisions. a successful project.
success? • A partner who takes on the
project’s responsibilities.
There seem to be many cost-effec- • A partner who supervises the
tive solutions – at a first glance. interfaces between the individual
project phases and thereby
However, if you set great importance ensures smooth procedures. You w a nt su c c ess?
on quality, performance, functiona- • A partner who is a drug producer
lity, flexibility, latest state of the art and machinery manufacturer G l a t t i s y o u r p a r t n e r.
technology, and efficiency in the himself.
long-term, you will need a partner • A partner who integrates Tell us your targets -
who provides the best solution machinery in an enterprise We w i l l h e l p y o u
– your partner is Glatt. 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 Our experts are team workers. A company with worldwide
management - from the first idea to They activities
the implementation of your prod uc- • conduct location and efficiency
tion. We are able to do this because analyses, At present, the Glatt Group employs
we can rely on many years of expe- • engineer processes and plants, approx. 1,500 employees in more
rience in engineering and installation • submit proposals for process than 20 companies worldwide.
of turnkey production facilities and optimization, Numerous representative offices
approved production plants in the • create financing concepts, are at your worldwide disposal, and
pharmaceutical industry. • integrate equipment in existing offer Glatt's complete range of
buildings, machinery, and services.
Moreover, as we incorporate and computer environments, This means: reliability, financial
coordinate all the partners and sub- • engineer and specify all the details, security, and worldwide service for
contractors, there is only one single • manufacture equipment your projects.
contact person for your entire project. components in Glatt’s own
manufacturing facilities,
This provides you with a sound basis • supervise construction sites, Before we move on to the
for the success of your investment. • coordinate deliveries, machinery...
• install and commission plants,
• qualifcation of equipment and Who does everything, often does
A company with an extensive plants according to current GMP nothing properly. That is why we
service portfolio regulations of the EU and US as focus on things that we are expe-
necessary, rienced in. This is the reason why
Regardless of whether a new instal- • provide reliable service. Glatt's machines and plants are
lation, extension or modernization/ leading products. For all other
GMP upgrading, individual compo- applications, we obtain the best
nents, complex production lines, or technologies on the market for you
complete production facilities - we and integrate them into a functional
design, engineer, and implement plant network.
high-performance and reliable pro-
duction processes for solid, sterile, You obtain long-lasting system com-
and other non-sterile drugs. patibility of plants and components,
spare parts, training, and much
more – in short: exactly what you
need, from one source.

3
 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 • Dispensing of solid, semi-solid, or • High productivity thanks to short
separate components and process liquid raw materials, batch or raw weighing cycles and optimized
modules for the precise dispensing material oriented container handling
of all active ingredients and raw • Single-component or cumulative • Flexible batch preparation
materials. Containment level con- weighing into intermediate • Exact dosing for large, medium,
cepts depending on occupational containers or directly into process and small quantities, manually or
exposure level (OEL). containers from drums, containers, or silos
• Raw material preparation • Raw material identification, raw • Absolutely strict separation of raw
(sieving, milling) material control, recipe and materials
• Dispensing of bulk ingredients, residue management • Support of process and cleaning
e.g. from big-bags, sacks, and • Electronic data management and validation
drums documentation, as well as the
• Accurate, clean, and reproducible transmission of weighing data to
dosing of small quantities SCADA systems

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
Multi-level concept: Process plants and handling systems with vertical product flow
transfer by means of gravity in a multi-
level concept?
High containment level? • Stainless steel containers in a • Plants for cleaning solution
variety of shapes and sizes preparation
• Stationary and mobile lifting • Advanced data management and
When designing and engineering columns for drum and container documentation systems for the
individual handling processes the discharge automatic acquisition and evalua-
basic process layout is a crucial • Human driverless transport tion of all the relevant process
point. systems - HDV data (e. g. barcode, Mobby...)
We develop functional, efficient, and • Drum and container blenders
GMP-complaint concepts – from • Modular systems with special
dispensing to packaging. docking units for low-contami- You benefit from
• High flexibility for quick product
Our offer changes and for swift implementa-
A comprehensive portfolio of tion of different process variants
integrated system components - from • Safe, low-contamination handling
a simple lifting column to a fully • Easy operation
automatic production facility: • 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 Our offer
handling. Great rationalization The design of GMP-compliant, perfor- • Central control and integration
potentials are to be found in the mance-optimized, and flexible packa- in IT-systems using open software
production logistics field, such as ging, storage, and transport logistics. standards with defined interfaces
just-in-time, pull principle, Kanban • Filling and packaging lines for
control, etc. any dosage forms and packaging
materials, being flexible
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?
Filling from Big-Bags
Automatic material consumption
control?
Line-oriented organization?
We assist you with your selection in You benefit from
High rack storage
view of the various alternatives! • Minimized operator intervention
for quick format change, semi- and error elimination by extensive
automated or computer-controlled automation
• Packaging robots and complete • Precicely predictable production
secondary packaging lines and lead times
• Pallet and small parts storage • Minimized stock and supplies
facilities - manually operated or storage by advanced production
automated logistics and thereby a reduction
• Combinations of rack and convey- of intermediate storage and
ance equipment that are fully material buffers
compatible • Optimized transport routes that
• Mobile and fixed terminals for reduce lead times
paperless order picking, reple- • Optimal use of storage areas
nishment control, and material • High turnover rate
flow control by radio data trans-
mission or infrared technology
Bottle filling

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

• Assessment and definition of

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

Closed product flow in the granulation line

The success of your investment • A future-oriented production must • A future-oriented production must
depends on a variety of factors. High- offer the highest product quality ensure the maximum pharma-
performance and efficient processes for various recipes and packa- ceutical safety for operators,
play a crucial role. ging forms. product, machinery and environ-
This is possible with Glatt as your ment, even if high potent products
partner. are handled.
• A future-oriented production must This is possible with Glatt as your
have fast and intelligently control- • A future-oriented production must partner.
led processes within a flexible ensure reproducible processes
plant system network with with high plant availability and • A future-oriented production must
functional system interfaces. short process lead times. be GMP-compilant and meet any
This is possible with Glatt as your This is possible with Glatt as your bylaws, regulations and standards.
partner. partner. 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.

15
 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: [email protected]

Russia
Glatt Ingenieurtechnik GmbH
ул. Обручева, 23 - корп. 3
117630 Москва/Россия
Phone: +7 495 78742-89
Fax: +7 495 78742-91
eMail: [email protected]

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: [email protected]

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: [email protected]
eMail: [email protected]
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: [email protected]

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: [email protected]

www.glatt.com

We set
the standard