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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
Schematic diagram of the vacuum steam process
Principle and Technology of the Vacuum Steam Process
Evacuating Heating Sterilizing Cooling
The vacuum steam process ensures complete elimination of air from
the chamber and sterilizing load. Therefore, penetration of satura-
ted steam into machine part openings and porous goods is secured.
Heating and sterilizing is done through direct inflow of clean steam.
Supported through the heated jacket, the required sterilization
result is achieved. Drying is done through further evacuation steps
(simple or fractionated) and a final ventilation with sterile filtrated
compressed air.
Clean steamCompressed
airSteam
Vacuum/Condensate Jacket 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 [email protected]