www.fabermoldenhauer.de

SBM Schoeller-Bleckmann Medizintechnik Ges.m.b.H a Bosch Packaging Technology Company Pharmastraße 1 A-2630 Ternitz Austria Tel. +43 2630 312-0 Fax +43 2630 359 47 [email protected]

579-15123

SBM Schoeller-Bleckmann Medizintechnik Product Sterilization

2  |  Overview

Product Sterilizers from the Inventor of the Steam/Air Mixture Process SBM Schoeller-Bleckmann Medizintechnik

Know-how

specializes in the development and

The sterility of pharmaceutical products required by

production of sterilizers for the pharmaceutical industry. Many years of close cooperation with global leading pharmaceutical companies are reflected in the excellent quality and execution of products made by SBM.

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 solutions 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.

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.

Comparison of Rototherm SDR and Aquatherm SWS  |  3

Rototherm SDR Sterilization with Steam/Air Mixture

Aquatherm SWS Sterilization with Hot Water Shower

Applications  Bottles made of glass/plastic

Applications  Bottles made of glass/plastic

 Single-/multi-bags

 Single-/multi-bags

 Prefilled syringes made of glass/plastic

 Ampoules, vials made of glass/plastic

 Ampoules, vials made of glass/plastic  Blood bag systems  Contact lenses

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

4  |  Rototherm SDR

Rototherm SDR Sterilization 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)

Rototherm with side wall mounted spray nozzles for spray cooling



Contact lenses



Nested glass syringes

6  |  Rototherm SDR

 Circulation of the chamber atmosphere  Heating

Principle and Technology of the Steam/Air Mixture Process

 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 Compressed air

Cooling water

Condensate

Schematic diagram of the steam/air mixture process

Clean steam Compressed air

Cooling water

Rototherm SDR  |  7

Typical Features

Radial fans

Baffle plates

Heat exchangers

These are designed for high circula-

These are specifically adjusted to

These are designed as high-effi­

tion performance, uniform tempera-

the product or load configuration for

ciency fin coil heat exchangers for

ture rise during heating, optimal

guided flow of the steam/air mixture.

efficient cooling.

temperature distribution during

Side wall inflow openings are provi-

sterilization, and efficient cooling.

ded for horizontal flow to optimize temperature distribution.

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

8  |  Aquatherm SWS

Aquatherm SWS Sterilization with Hot Water Shower

Aquatherm SWS  |  9

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 specifically suited for products requiring short temperature residence times. 

Available chamber sizes from 0.3 m3 bis 40 m3

Glass bottles for IV solutions

Filled glass vials

Aquatherm prepared for floor-level loading

Blow Fill Seal (BFS) products (Photograph by courtesy of rommelag AG)

10  |  Aquatherm SWS

Principle and Technology of the Hot Water Shower 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.

Compressed air

Industrial steam

Condensate

Circulation pump

Schematic diagram of the hot water shower process

Aquatherm SWS  |  11

Typical Features

Circulation pump

External heat exchanger

Perforated plates/spray nozzles

The pump is designed for high circu-

FDA-compliant double-tube

Perforated plates or spray nozzles

lation performance, uniform tempe-

sheet heat exchanger.

designed to achieve an optimal

rature rise during heating and opti-

water shower are used in accordance

mal temperature distribution during

with the product containers to be

sterilization.

sterilized.

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

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

Packed blood bag systems

Side wall mounted spray rig

Automatic loading or unloading systems

Accessories   |  13

Carpules in boxes

Packed disposable syringes

Accessories for Product Sterilizers

Rotation device

14  |  Automation and control system

Automation and Control System Operating, Monitoring, Controlling, Documenting Remote maintenance HMI Unloading side

Network printer

Control panel

Data archive HMI Loading side

Lo

 Data storage  User administration  Formulation administration

Pr

Customer

ofi

bu

s

ca

la

re

an

et w

or

k

Batch printer

Remote maintenance via VPN access

SBM Sterilizer Hardware configuration

SBM Schoeller-Bleckmann Medizintechnik

To guarantee maximum reliability and global availa­

supplies and delivers premium complete-line

bility, SBM exclusively uses control platforms made

systems for the control, visualization or documentation of sterilization processes.

by the leading suppliers Siemens or Allen Bradley. Specifically, the high flexibility of the SBM control system allows us to customize the equipment in

This automation and control system is the outcome of

terms of program flow, visualization and documenta-

many years of cooperation between SBM and experts from

tion.

the pharmaceutical industry with a view to providing our customers with maximum sterilization reliability.

The 21 CFR Part 11 requirements are satisfied. SBM develops its software in accordance with the latest valid GAMP standards.

Services  |  15

Our Services – more than just servicing or repair

 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 development sterilizer. This helps us identify the optimal sterilization process for your specific product through the use of different processes or combinations of processes.

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