Sterilization system for biosafety applications
Ensure sterility and compliance in critical manufacturing processes with a versatile solution designed for precise load decontamination and efficient cycle control.
Sterilizes and Decontaminates for Safe Biopharmaceutical Operations
The Finn-Aqua BPS Sterilizer from STERIS is expertly designed for rigorous biopharmaceutical and pharmaceutical applications, ensuring precise sterilization and effective decontamination. Utilizing pre-programmed cycling with customizable parameters, it maintains exposure temperatures within ±0.5 °C for reliable results. Applications include media preparation and terminal sterilization of vaccines, APIs, and lab samples. The stainless steel AISI 316L chamber minimizes corrosion, extending durability. With full integration capabilities, it supports both batch and continuous operations, offering loading and transfer modules to suit various load types. The system complies with GMP, cGMP, GAMP, and EU Annex 1 standards, ensuring your processes meet stringent regulatory requirements. Moreover, its design allows easy validation and features a broad selection of cycle alternatives, making it versatile for demanding environments.
Benefits
- Ensures compliance with GMP and regulatory standards, reducing risk in pharmaceutical production.
- Offers cycle versatility to handle diverse load types, increasing operational flexibility.
- Enhances equipment longevity with corrosion-resistant chamber materials.
- Facilitates quick and straightforward validation, minimizing setup time.
- Streamlines process integration with smart automation and interface options.
- Applications
- Research and development,Medical devices,Biosafety applications,Biopharmaceuticals,Sterile medicinal products,Pharmaceuticals
- End products
- Laboratory samples,Vaccines,Sterile solutions,Active pharmaceutical ingredients (apis),Monoclonal antibodies,Packaged surgical instruments,Injectable medications,Medical device components,Diagnostic kits,Cell therapies
- Steps before
- Media Preparation,Load Preparation
- Steps after
- Decontamination,Terminal Sterilization,Sterile Room Supply
- Input ingredients
- media preparation materials,hard goods,vented liquids,sealed packaged liquids,loads for decontamination
- Output ingredients
- sterile media,sterilized hard goods,sterilized vented liquids,sterilized sealed packaged liquids,decontaminated loads
- Market info
- Steris Finn-Aqua is known for manufacturing high-quality steam sterilizers and water purification systems, specializing in clean utilities for pharmaceutical and biotech industries. Their equipment is recognized for reliability and meeting stringent industry standards.
- Chamber Material
- AISI 316L stainless steel
- Carbon Content
- Less than 0.03%
- Temperature Control
- Maintained within ±0.5 °C
- Cycle Options
- B,BX,C,CX,DEC F,DEC V,DEC +C,SAMX,AC,GdT,RP
- Working mechanism
- Pre-programmed cycles
- Cycle temperature regulation
- Maintained within +/- 0.5°C
- Recipe selection
- Pre-programmed 'recipe' list
- Automation level
- User customizable parameters
- Cycle versatility
- Various cycles available (B,BX,C,CX,DEC F,DEC V,DEC +C,SAMX,AC,GdT,RP)
- Batch vs. continuous operation
- Batch
- Cleaning method
- CIP compatible
- Cycle time
- Varies with application
- Decontamination support
- Biosafety classified applications
- Corrosive resistance (e.g. acids)
- AISI 316L stainless steel
- Chamber Material
- AISI 316L stainless steel
- Corrosion Resistance
- Maximum carbon content less than 0.03%
- Compact Footprint
- Not specified
- Cycle Versatility
- B,BX,C,CX,DEC F,DEC V,DEC +C,SAMX,AC,GdT,RP
- Exposure Temperature Control
- Maintained within +/- 0.5 °C
- Control panel type
- Recipe-based pre-programmed cycles
- User customization
- Customizable cycle parameters
- Cycle selection
- Broad selection of features and cycles