Glatt Production of solid drugs

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W e s e t t h e s t a n d a r d

Consulting

Design

Engineering

Supply

Installation

Commissioning

Qualification

Instruction and training

Support and service

Integrated solutions from one source

P r o d u c t i o n o f s o l i d d r u g s

Tablets

Capsules

Sachets

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just replace outdated machinery.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.

Y o u h a v e a t a r g e t

Launchingnew productsmore rapidly.Improvingcompetitiveness viaeff icient processes.

You want success?

Glatt is your partner.

Tell us your targets -We will help yourealize them.

• A partner who develops the

bases for your decisions.

• 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.

• A partner who is a drug producer

and machinery manufacturer

himself.

• A partner who integrates

machinery in an enterprise

management system.

• A partner who sets the course for

a successful project.

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Why we can do this.How we can do this.

W e p a v e t h e w a y

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 produc-

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.

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.

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G M P s t a n d a r d a l l a l o n g t h e l i n e

Regardless of which solid

dosage forms you intend

to produce, whether you

want tablets, capsules,

sachets and f inal

packaging - we guarantee

the highest eff iciency

and product quality.

State of the arttechnology.From raw materialreceiving to drugsready to dispatch.

Raw material receiving andsampling

Weighing & dispensing (p. 5)

Granulation & pelletizing (p. 6)

Forming (p. 8)

Coating (p. 8)

Quality control (p. 8)

Product handling (p. 10)

Packaging, storage and materialtransport (p. 11)

Utility systems (p. 12)

Material flow in a layout for tablet production

Glatt designs the processes and

systems, as well as supplies and

integrates the machines and equip-

ment for all solid drug production

processes.

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W e i g h i n g & d i s p e n s i n g

Weighing.Dispensing.Documentation.Safe recipes foryour success.

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

Automatic bulk ingredient weighing

• 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

When designing, engineering, and

implementing systems for raw

material dispensing we fully consider

your specific requirements for sizing

and design.

Our offer

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

You benefit from

• 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

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G r a n u l a t i o n & p e l l e t i z i n g

Mixing.Granulating.Pelletizing.Drying.From the expert ofintegrated processtechnology.

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

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G r a n u l a t i o n & p e l l e t i z i n g

... with vertical product flow

• 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

• Intelligent user-friendly process

control

• High efficiency thanks to the

integrated optimized sequences

... with horizontal product flow

Wet granulation in the Glatt Vertical Granulator

Fast efficient wet mixing (e.g. Glatt VerticalGranulator) with subsequent gentle drying inthe fluid bed system (e.g. Glatt fluid bed drier)

Discharge from a Glatt fluid bed drier

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F o r m i n g , c o a t i n g a n d q u a l i t y c o n t r o l

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

the optimal combination regarding

equipment, material handling, and

process environment, including all

the required laboratories for

microbiological and analytical quality

control.

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

Tabletting. Capsulef il l ing. Film coating.Sugar coating.Perfect in shape witha functional and/orprotective layer.

From the tablet press to the coater with horizontal (left) or vertical (right) product flow

Tablet press charging via a Glatt lifting column

Compounding system for coating solutions

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F o r m i n g , c o a t i n g a n d q u a l i t y c o n t r o l

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


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


Lifting. Tilt ing.Weighing. Dosing.Conveying.Blending. Swivelling.Docking. Fil l ing.Discharging.Cleaning. Storing.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:

• 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-

nation charging and emptying

(e.g. Glatt containment valve)

• Accurate dispensing and dosing

systems

• Vacuum conveying systems for

product transfer

• Container cleaning systems

P r o d u c t h a n d l i n g

•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

Vibration dosing sieve

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Multi-level concept: Process plants and handling systems with vertical product flow

Automated dispensing system on a driverlesstransport system

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 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

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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!

3D storage engineering

• Central control and integration

in IT-systems using open software

standards with defined interfaces

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

Bottle filling

P a c k a g i n g , s t o r a g e a n d t r a n s p o r t

Packaging.Inspecting.Labelling.Palletizing. Storing.Consignmenting.Transport .Documentation.

High rack storage

Filling from Big-Bags

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The so-called utility systems, as we

see them, are not secondary.

You will obtain a solution that is

tailored to your company require-

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

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

Cleanrooms. Water.Air -conditioning andVentilation.Compressed air.Cleaning Systems.Electric powersupply. Controltechnology. IT.

Cleanroom wash place

Changing room

Cleanroom corridor

U t i l i t y s y s t e m s

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• 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

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

CIP station

Air-conditioning and ventilation

Chiller

Water treatment

U t i l i t y s y s t e m s

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Calibration

• 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

• 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

Process control diagram - granulation process

Consulting. Design.Engineering.Coordination.Installation.Commissioning.Qualif ication.Instructing.Supporting.

• 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

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.

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

S e r v i c e s a n d s u p p o r t

Survey

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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.

Eff icient processes.Future-orientedtechnology.High-quality products.Flexibility. Safety.Time to Market.


ensure the maximum pharma-

ceutical safety for operators,

product, machinery and environ-

ment, even if high potent products

are handled.


partner.


be GMP-compilant and meet any

bylaws, regulations and standards.


partner.


ensure a quick market support and

highest competitiveness in quality

and cost to secure the location of

your facility.


partner.


offer the highest product quality

for various recipes and packa-

ging forms.


partner.


ensure reproducible processes

with high plant availability and

short process lead times.


partner.

Make the rightstrategic decision.This of fer is yourticket to a future-oriented production.

Trust in Glatt .

Y o u r b e n e f i t s

Closed product flow in the granulation line

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G l a t t E n g i n e e r i n g

Headquarter

Glatt Ingenieurtechnik GmbH

Nordstraße 12

99427 Weimar/Germany

Phone: +49 3643 47-0

Fax: +49 3643 47-1231

eMail: [email protected]

First addresses for f irst -class services.We of fer more than process equipment.We provide integrated solutions.

International located:

GermanyGlatt Ingenieurtechnik GmbHNordenstadter Str. 3665207 Wiesbaden/GermanyPhone: +49 611 89069-7Fax: +49 611 89069-88eMail: [email protected]

RussiaGlatt Ingenieurtechnik GmbHул. Обручева, 23 - корп. 3117630 Москва/РоссияPhone: +7 495 78742-89Fax: +7 495 78742-91eMail: [email protected]

IndiaGlatt (India) Pharma Engineering Pvt. Ltd.13 Ground Floor Palam Marg, Vasant ViharNew Delhi – 110057/IndiaPhone: +91 11 46052960Fax: +91 11 46052964eMail: [email protected]

SwitzerlandPharmatronic AGHohenrainstraße 104133 Pratteln/SwitzerlandPhone: +41 61 826-9726Fax: +41 61 826-9727eMail: [email protected]

Italypgs engineering s.r.l.Via F. De Lemene, 820151 Milan/ItalyPhone: +39 02 3349-1015Fax: +39 02 3349-0270eMail: [email protected]

USARamsey Design Group(Division of Glatt Air Techniques Inc.)20, Spear Road, Ramsey, NJ 07446/USAPhone: +1 201 825-1391Fax: +1 201 825-0389eMail: [email protected]

www.glatt.com

Documents

Glatt Production of solid drugs