SBM Schoeller-Bleckmann Medizintechnik Product Sterilization

SBM Schoeller-Bleckmann Medizintechnik Product Sterilization

2 Overview Product Sterilizers from the Inventor of the Steam/Air Mixture Process SBM Schoeller-Bleckmann Medizintechnik specializes in the development and 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. 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 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 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 Steam/Air Mixture For open or closed containers Product is removed completely dry after sterilization Heating with clean steam Sterilizing medium: clean steam AQUATHERM SWS Hot Water Shower For sealed containers Product is removed wet after sterilization Heating with industrial steam Sterilizing medium: demineralized water Overall cycle time t SDR Overall cycle time t SWS t SDR 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 m 3 to 40 m 3 Plastic bags for IV solutions (Photograph by courtesy of Plümat) Contact lenses Rototherm with side wall mounted spray nozzles for spray cooling Nested glass syringes

6 Rototherm SDR 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 air Compressed air Cooling water Cooling water Condensate Schematic diagram of the steam/air mixture process

Rototherm SDR 7 Typical Features Radial fans These are designed for high circulation performance, uniform temperature 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 provided for horizontal flow to optimize temperature distribution. Heat exchangers These are designed as high-efficiency 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

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 m 3 bis 40 m 3 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 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 pharmacopoeias. 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 The pump is designed for high circulation performance, uniform temperature rise during heating and optimal 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. 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 Customer HMI Unloading side Network printer Control panel HMI Loading side Data storage User administration Formulation administration Local area network Data archive Profibus Batch printer Remote maintenance via VPN access SBM Sterilizer Hardware configuration 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 availability, 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 documentation. 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

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 sales.sbm@bosch.com 579-15123