SBM Schoeller-Bleckmann MedizintechnikEquipment Sterilization

2 | Overview

Vacuum Steam Sterilizersfor Usage in the Pharmaceutical Industry

Sterile?For our sterilizers, the sterility of your equipment is a matter of

course. But, perhaps you are not using sterilizers made by SBM

as of yet? And are hence facing problems our customers simply

do not know of at all? If you, too, make high demands to the

sterility of your equipment, just contact our application engi-

neers. SBM will be just the right partner to develop, manufac-

ture or commission your customized sterilizer.

SBM Schoeller-Bleckmann Medizintechnik

specializes in the development and

production of sterilizers for the pharmaceuti-

cal industry. Many years of close cooperation

with global leading pharmaceutical companies

are reflected in the excellent quality and

execution of products made by SBM.

Know-how

The sterility of pharmaceutical products required by

international pharmacopoeias is guaranteed through the

high reliability of the SBM systems. For more than 35

years, innovation and high product availability have

turned our customers into real partners.

Efficiency

SBM offers economic safety and technological advance,

thus laying the foundation to develop customized solu-

tions in a joint effort.

Ecology

Up-to-date measuring and control technology ensure

that SBM units operate as resource saving as possible.

This preserves the environment and guarantees low

operating costs.

Internationality

As a Bosch company, SBM has access to a worldwide

distribution and service network, which offers the

advantage of local contacts.

Security

A personal contact is available for each unit to ensure

that the project runs smoothly.

Vakutherm ADV | 3

Vakutherm ADVSterilization with Vacuum Steam

Applications Textiles, utensils, machine parts

Empty glass or metal containers

Filters

Instruments with or without over wrapping

Blister-packed goods

Further Applications Empty syringes

Decontamination of infectious goods acc. to BSL 1/2/3

Dialysis filters

Glass ampoules up to 10 ml

Solutions in open containers

Rubber stoppers in Tyvek bags

Animal cages, animal food etc.

4 | Vakutherm ADV

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C l e a n s t e a mC o m p r e s s e d

airS t e a m

V a c u u m / C o n d e n s a t eJacket condensate

Sterile filter

Vakutherm ADV | 5

Typical Features

Automatic “Filter-in-line” Sterilization

If required, the sterilizer can be executed with auto-

matic filter-in-line sterilization to ensure that the

filter incl. corresponding piping remain germ-free.

Additional Equipment Support pressure device for sterilization of liquids Cooling device:

· Jacket cooling

· Jacket cooling with fan

· Internal heat exchangers with fan Washing equipment for e. g. containers, Lyo frames etc. Filter integrity test Secondary cooling loop Water saving device for vacuum system Automatic loading systems Steam generator

Further equipment available on request

Encapsulated Door Drive

The encapsulated door drive is characterized through low

maintenance effort (without lubrication) and effectively

prevents particle release to the surroundings. Therefore, it

is best suitable for operation in clean rooms.

6 | Automation and control system

Automation and Control SystemOperating, Monitoring, Controlling, Documenting

SBM Schoeller-Bleckmann Medizintechnik

supplies and delivers premium complete-line

systems for the control, visualization or

documentation of sterilization processes.

This automation and control system is the outcome of

many years of cooperation between SBM and experts from

the pharmaceutical industry with a view to providing our

customers with maximum sterilization reliability.

To guarantee maximum reliability and global availa-

bility, SBM exclusively uses control platforms made

by the leading suppliers Siemens or Allen Bradley.

Specifically, the high flexibility of the SBM control

system allows us to customize the equipment in

terms of program flow, visualization and documenta-

tion.

The 21 CFR Part 11 requirements are satisfied.

SBM develops its software in accordance with the

latest valid GAMP standards.

Hardware configuration

Batch printer

Local area network

Remote maintenancevia VPN access

Network printer

Remote maintenance

Data archiveControl panel

HMIUnloading side

HMI Loading side Data storage User administration Formulation administration

Profibus

SBM Sterilizer

Customer

Service | 7

The Result: Sterile End Product

The processes and measurements should be

chosen in such a way, that the result is a theoretical

amount of functional germs (living germ) of utmost

1 x 106 sterilized units of the final product.*

*Definition acc. to Wallhäußer, Praxis der Sterilisation, 5. Auflage, 1996

Maintenance, servicing or repair Support for periodic checkups or inspections through

public authorities Supply and delivery of spare and wear parts Maintenance agreements Training of operators or maintenance staff Hardware or software upgrades Recalibration or requalification Global sales and servicing network

Technology Center for sterilization

The SBM Technology Center is equipped with a research and develop-

ment sterilizer. This helps us identify the optimal sterilization process for

your specific product through the use of different processes or combina-

tions of processes.

Our Services – more than just servicing or repair

www.fa

berm

olde

nhau

er.de

579-15117

SBM Schoeller-Bleckmann Medizintechnik Ges.m.b.Ha Bosch Packaging Technology Company

Pharmastraße 1 A-2630 Ternitz AustriaTel. +43 2630 312-0Fax +43 2630 359 47sales.sbm@bosch.com