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SBM Schoeller-Bleckmann MedizintechnikProduct Sterilization
2 | Overview
Product Sterilizersfrom the Inventor of the Steam/Air Mixture Process
Sterile?For our sterilizers, maximum sterility of the final product is a
matter of course. But, maybe you are not using sterilizers made
by SBM as yet? And are hence facing problems our customers
simply do not know at all? If you, too, require maximum sterility,
just contact our application engineers. SBM will be just the right
partner to develop, manufacture 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.
Comparison of Rototherm SDR and Aquatherm SWS | 3
Rototherm SDRSterilization withSteam/Air Mixture
Applications Bottles made of glass/plastic
Single-/multi-bags
Prefilled syringes made of glass/plastic
Ampoules, vials made of glass/plastic
Blood bag systems
Contact lenses
Applications Bottles made of glass/plastic
Single-/multi-bags
Ampoules, vials made of glass/plastic
ROTOTHERM SDR AQUATHERM SWS
Steam/Air Mixture Hot Water Shower
For open or closed containers For sealed containers
Product is removed completely dry after sterilization
Product is removed wet after sterilization
Heating with clean steam Heating with industrial steam
Sterilizing medium: clean steam Sterilizing medium: demineralized water
Overall cycle time tSDR Overall cycle time tSWS tSDR x 0.8
Aquatherm SWSSterilization withHot Water Shower
4 | Rototherm SDR
Rototherm SDRSterilization with Steam/Air Mixture
Rototherm SDR | 5
The steam/air mixture process was developed by Dr. Kalasek
(Technomedica – Schoeller-Bleckmann), and specifically
patented for the pharmaceutical industry. Based on this head
start and continuous further development of this process,
SBM Schoeller-Bleckmann Medizintechnik has been able to
maintain its position as the leading supplier of steam/air
mixture sterilizers.
Available chamber volumes from 0.3 m3 to 40 m3
Plastic bags for IV solutions (Photograph by courtesy of Plümat)
Contact lenses
Nested glass syringesRototherm with side wall mounted spray nozzles for spray cooling
6 | Rototherm SDR
Schematic diagram of the steam/air mixture process
Principle and Technology of the Steam/Air Mixture Process
Circulation of the chamber atmosphere Heating Sterilizing Cooling
Circulation and directed flow across the load are achieved through
powerful radial fans and air baffles in the chamber. Heating and
sterilization occur through direct inflow of steam into the chamber.
Cooling is provided via internal high-performance heat exchangers.
Temperature distribution outperforms the requirements made by
international pharmacopoeias. Controlled pressure overlap through
sterile filtered air during the whole process will ensure the product
containers to stay in perfect shape.
Clean steam Clean steam
Compressed airCompressed air
Condensate
Cooling water Cooling water
Rototherm SDR | 7
Typical Features
Radial fans
These are designed for high circula-
tion performance, uniform tempera-
ture rise during heating, optimal
temperature distribution during
sterilization, and efficient cooling.
Baffle plates
These are specifically adjusted to
the product or load configuration for
guided flow of the steam/air mixture.
Side wall inflow openings are provi-
ded for horizontal flow to optimize
temperature distribution.
Heat exchangers
These are designed as high-effi-
ciency fin coil heat exchangers for
efficient cooling.
Additional equipment Frequency converter for fan drive Heatable heat exchangers Vacuum equipment Manual or automatic
filter-in-line sterilization Accessible chamber Loading and handling systems Horizontal flow process for bag
sterilization
Further equipment available on request
Aquatherm SWSSterilization with Hot Water Shower
8 | Aquatherm SWS
Hot water shower washing is an efficient process for the
sterilization of sealed containers. Short overall cycle times
and hence high throughput rates are achieved through
direct exposure of the load to water. This process is speci-
fically suited for products requiring short temperature
residence times.
Available chamber sizes from 0.3 m3 bis 40 m3
Aquatherm SWS | 9
Glass bottles for IV solutions
Filled glass vials
Blow Fill Seal (BFS) products (Photograph by courtesy of rommelag AG)
Aquatherm prepared for floor-level loading
10 | Aquatherm SWS
Principle and Technology of the Hot WaterShower Process
Filling with process water Circulation of the water Heating Sterilizing Cooling
The process water is circulated through high-performance pumps
via heat exchangers. Industrial steam or cooling water is admitted
to the external heat exchanger. The temperature distribution
outperforms the requirements made by international pharmaco-
poeias. Controlled pressure overlap by means of sterile filtered
air throughout the whole process ensures the product containers
to stay in perfect shape.
Schematic diagram of the hot water shower process
Industrial steam
Compressed air
Condensate
Circulation pump
Additional equipment Frequency converter for circulation
pump Separate heat exchangers for heating/
cooling Manual or automatic filter-in-line
sterilization Accessible chamber Loading and handling systems Side wall mounted spray nozzle system
Further equipment available on request
Aquatherm SWS | 11
Typical Features
Circulation pump
The pump is designed for high circu-
lation performance, uniform tempe-
rature rise during heating and opti-
mal temperature distribution during
sterilization.
External heat exchanger
FDA-compliant double-tube
sheet heat exchanger.
Perforated plates/spray nozzles
Perforated plates or spray nozzles
designed to achieve an optimal
water shower are used in accordance
with the product containers to be
sterilized.
12 | Special applications
Special Applications for Product Sterilization
Tyndallization of blood
plasma products Heat treatment ≤ 100 °C Contact lenses in
blister packs Rotation device for
fat emulsions Prefilled syringes with or
without blister pack Packed blood bag systems
Automatic loading or unloading systemsSide wall mounted spray rig
Packed blood bag systems
Accessories | 13
Accessories for Product Sterilizers
Rotation device
Carpules in boxes Packed disposable syringes
14 | Automation and control system
Automation and Control SystemOperating, Monitoring, Controlling, Documenting
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
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.
Services | 15
The Result:Sterile End Product
Definition of terminal sterilization
Sterilization of finished pharmaceuticals
in their final container in which an aqueous
formulation is processed to provide a
minimum probability of a non-sterile unit
of 1 x 10-6.*
*Definition acc. to PDA Technical Memorandum
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
579-15123
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]