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

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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 47sales.sbm@bosch.com