Production of liquid drugs

Injectable solutions

Infusion solutions

Vaccines

Blood plasma products

Liquid/drops

Ointments/creams

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just replace outdated machinery.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 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 specifies, supplies, and inte-

grates machinery and equipment for
all the processes required to produce
liquid drugs.

9 7
6 3

10

1 2
12

11

Product flow in a typical layout for infusion solution production with Blow-Fill-Seal technology in an
existing building

1 Raw material receiving and 7 Sterilization (p. 8)

sampling
Regardless of which
2 Dispensing 8 (Freeze drying)*
pharmaceutical liquids you
3 Solution preparation (p. 5) 9 Quality control (p. 9) intend to produce or how they
are to be filled and packed,
4 (Manufacture of containers)* 10 Secondary packaging (p. 10) either in bags, syringes,
vials, or bottles, from glass
5 (Primary container preparation)* 11 Storage and material transfer
(p. 10) or plastic - we guarantee for
6 Filling (p. 6) 12 Utility systems (p. 12) efficiency and the highest
product quality.
* additional process steps for other liquid production

4
 Solution preparation
Weigh ing. D o s i n g .
Mixing. F iltration.
Temperature control.
Documentation.
Accurate fo r m ulation
for a reproducible
fo r m u l a.
Product quality and security as well
as functionality come first when
designing, engineering, and imple-
menting the solution preparation area
for liquid processes.
It goes without saying that we take
into account your specific design
and layout requirements.
Our offer
Complete solution preparation lines,
as well as individual components and
modules for the production of
injection and infusion solutions, eye
drops, and other liquid products that
are integrated into adapted concepts
for different containment levels.
3D engineering: solution preparation system with
sterile filter
Vaccum raw material dispensing
• Manual and automatic systems for
solution preparation tank filling,
e.g. adding active pharmaceutical
ingredients via vacuum suction
system
• Solution preparation tanks in a
variety of sizes and types, from
simple mobile tanks to stationary
solution preparation tanks with
various agitators, that can be
heated and cooled
Solution preparation tank with sterile filter
5
Vaccum raw material dispensing
• Automated CIP/SIP processes for
any product-contact components
and interconnecting pipework
• Solution transfer by overpressure/
vacuum or pumps
• Filter systems for in-line sterile
filtration with product-specific
diaphragms, several filter stages
and in-line filter tests
• Product-specific solution prepara-
tion and temperature management
• Specially for your process develo-
ped tailor made automation
systems with recept control and
management in compliance with
all relevant regulations
You benefit from
• High productivity thanks to
optimized process times
• Flexible batch preparation
• Exact dosing, even for the
smallest of quantities
• Reliable and quick mixing
• Absolutely clear separation of
different media
• Support of process and cleaning
validation
 Filling primary containers

Pref illed syr inges.

Vials. Ampoules.
Bottles. Bags.
Car tr idges.
Made from glass or
plastic. Standard or
b l o w -f i l l - s e a l ( B F S )
technology.

Filling of large-volume (LVP) or small-

volume (SVP) injection/infusion con-
tainers or unit dose receptacles, e.g.
for eye, nose, and ear drops.
You determine the type of container
that is required. We provide profes-
sional advice in respect of a suitable
filling technology, as this is the main
factor that determins the production
costs and the handling.

Our offer
Our offer includes the design and
engineering of filling technology
tailored to your individual needs,
including the delivery and integra-
tion of advanced, easy-to-operate
plant equipment of the highest
quality and reliability.
Bottles in the welding unit
Bottle packing installation for infusion solution’s filling with blow-fill-seal technology
• Plants for filling disposable
syringes, ampoules, bottles, and
vials as stand-alone components or
as a line concept with or without
isolators
• Bottlepack plants (blow-fill-seal
technology) in a modular design,
with one or more moulds, laminar
flow, and in-line ASR space
for the filling area, which can be
sterilized by steam
• Cap welding machines for the
absolute sterile sealing of infusion
containers
• Fully automated closing machines
to insert plugs, droppers, spray
pumps, pipettes, screw on caps,
to put on cover caps, and for
crimping
• Charging systems and transport
magazines for the relevant
components
• Efficient electronic systems for
entering, visualization, control, and
archiving of all the relevant pro-
cess and plant data, stand-alone or
with connection to management
networks
It is in this way that we meet all the
relevant requirements, such as di-
rect linking to upstream and down-
stream sterilization procedures,
black/white separation between the
filling and service/utility areas, or
the CIP/SIP capability of the systems.

6
 Filling primary containers

You benefit from

the use of the state of the art
technology:
• No operator intervention in the
filling area is needed
• Highest level of sterility, as the
goods to be filled and primary
containers are never exposed to
a non-sterile environment
• Overall equipment effectivness via
short starting and preparation
cycles
• Cost reduction thanks to mini-
mized space requirements and
the high extent of automation
• Maximum production capacity
Vial filling/packaging line
• Flexibility in design of the con-
tainers to be filled
• Integration of freeze-driers with
charging and discharging systems,
which can be semi- or fully auto-
matic systems

Plastic granulate container with suction lance

Euro cap feeding Cap welding machine

7
 Sterilization, inspection and quality control

Ster ilization before

and after f illing.
Maxim iz ed a s e p s i s .
Controlled.
Documented.
Guaranteed.

Product asepsis is mandatory.

We assist our customers in selecting
suitable sterilization systems.
We design, engineer, and install the
optimal combination of equipment
process sequence and process
environment including all the
required laboratories for microbio-
logical and analytical quality control.

Your decision for innovative pro-

cesses can reduce the amount
of investment needed for sterile
container preparation or even
Loading the sterilizer
make it unnecessary.

According to the requirements for ...we provide

your individual product (e.g. freeze-
dried products, thermo labile solu-
tions, pasty compounds) and the
container materials (glass and/or
plastic), the forms (bottles, ampoules,
and/or other) as well as the formats
you want to process...
the complete expertise necessary
for individual efficient solutions with
controlled, validated, and documen-
ted product quality.
In which case we integrate the latest
equipment with intelligent control
systems as stand-alone variants or
with connection to management
networks.
• Decontamination systems for un-
packing pre-sterilized receptacles
(e.g. preassembled disposable
syringes)
• Semi or fully automatic washing
machines to clean ampoules,
syringes, bottles, vials, plugs, etc.
• Hot-air sterilization tunnels to dry,
sterilize, and depyrogenate
receptacles before filling as a
stand-alone system or as a part
of complete filling lines
• High-performance and flexible
batch sterilization plants for the
automatic sterilization of glass
and plastic bottles or plastic bags
after filling and sealing (steam
spray autoclaves or water-rinsing
autoclaves)
• Autoclaves and hot-air sterilizers
to sterilize equipment and plant
components

Bottle transport to the steriliser

8
 Sterilization, inspection and quality control
• Loading and unloading systems
with different extents of automa-
tion (e.g. automatic de-/renesters
to handle syringes in trays)
• Fully automatic inspection machi-
nes with high-resolution camera
systems for the absolutely reliable
inspection of product (particle)
and receptacles (functional or
cosmetic defects) as well as
semiautomatic plants with visual
inspection
Microbiological laboratory
Microbiological laboratory
• Automatic machines for the
leakage testing of ampoules, vials,
and other receptacles
• Microbiological and analytical
laboratories with all essential
analytical equipment
Analytical laboratory
Analytical laboratory
You benefit from
• Minimized operating actions and
direct linking of upstream and
downstream process steps
• Absolutely reliable quality control
for the highest product security
• Product-compliant sterilization and
inspections
• Gentle handling of products and
receptacles
• Flexibility due to quick format
change
Microbiological laboratory
9
Packaging, storage and transport

P ack aging .
Ins pecting .
L ab el l ing.
Palletizing.
Stor ing.
C o ns ignm e n t i n g .
Transpor t.
Documentation.

Efficiency and flexibility are also

crucial when it comes to material
handling. Great rationalization
potentials are to be found in the
3D engineering: packaging line for bottled infusion solution
production logistics field, such as
just-in-time, pull principle, Kanban
control, etc. Transport and feeding of the packa- Automatic material consumption
ging material from a second level? control?
We develop a functional concept to 100% in-line monitoring? Line-oriented organization?
ensure that your products are safely In-line printing? We assist you with your selection in
packaged and quickly marketed. White Lines? view of the various alternatives!

Packaging line for bottled infusion solution

10
Packaging, storage and transport

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 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 con-

veyance equipment that are fully
compatible

• Mobile and fixed terminals for

paperless order picking, reple-
nishment control, and material
High rack storage
flow control by radio data trans-
mission or infrared technology

• Central control and integration in

IT-systems using open software You benefit from
standards with defined interfaces • Minimized operator intervention
and error elimination by extensive
automation
• Precisely predictable production
and lead times
• Minimized stock and supply
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

3D storage engineering

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 m m is s io n i n g .
Q u 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.
• 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
3D engineering - insulin production
• 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
Process control diagram - Formulation area for
an infusion solution
• 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
14
• 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
Calibration
 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 im 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.
• 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 n ational located:

© Glatt Ingenieurtechnik GmbH – Herstellung flüssiger 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