Steam sterilizer for pharmaceutical production
Ensure consistent, contamination-free sterilization of pharmaceutical components with this advanced steam sterilizer, designed to optimize biopharma production efficiency and maintain stringent quality standards.
Sterilizes and Validates Pharmaceutical Components
The GSS P Steam Sterilizer from Getinge is engineered to meet the stringent demands of the pharmaceutical and biopharmaceutical industries. This autoclave stands out with its reliable contamination prevention and user-friendly operation. Employing a controlled steam sterilization process, it facilitates batch, high-speed, and continuous operations, perfectly suited for applications involving injectable vaccines, sterile saline solutions, and lyophilized drugs.
Designed with flexibility in chamber sizes ranging from 0.4 to 9 cubic meters, it integrates seamlessly into various production environments. The intuitive HMI and SIMATIC WinCC Unified enhance operator control and monitoring, promoting ease of use and safety. With materials crafted from GMP-compliant, sanitary stainless steel, the GSS P ensures hygiene and durability, while robotic welding and polishing guarantee superior finish and corrosion resistance.
Configured for global compliance, it supports GAMP5 validation and adheres to GMP standards, ensuring certification across diverse regulatory landscapes. The integrated Quality Process Management System facilitates seamless validation and monitoring, while options such as B & R, Siemens, or Allen Bradley control systems provide versatile automation and integration capabilities. Getinge further offers extensive customization and engineering support to optimize configuration and operational efficiency.
Benefits
- Enhances production efficiency by ensuring consistent sterilization and cleaning.
- Minimizes contamination risks with GMP-compliant, sanitary stainless steel construction.
- Facilitates seamless integration into existing production lines with customizable chamber sizes.
- Supports regulatory compliance with advanced validation and global standards adherence.
- Optimizes operator workflow with user-friendly HMI and real-time process monitoring.
- Applications
- Pharmaceutical components,Biopharma,Biopharmaceuticals,Life sciences,Pharmaceutical production
- End products
- Lyophilized drugs,Insulin,Monoclonal antibodies,Pre-filled syringes,Sterile saline solutions,Injectable vaccines
- Steps before
- Component Preparation,Cleaning,Loading
- Steps after
- Unloading,Quality Control,Packaging
- Input ingredients
- pharmaceutical components,biopharmaceutical materials,equipment requiring sterilization
- Output ingredients
- sterilized components,contamination-free biopharmaceutical products
- Market info
- Getinge is known for providing innovative healthcare and life sciences products, specializing in medical technology, infection control, surgical workflows, and critical care solutions. They maintain a strong reputation for quality and technological advancement in these sectors.
- Chamber Volume
- 0.4 to 9 cubic meters
- Chamber Volume
- 10 to 400 cubic feet
- Automation
- SIMATIC WinCC Unified
- Control System
- B,R,Siemens,Allen Bradley
- Material
- Sanitary stainless steel
- Dimensions
- 660 x 700 x 1000 mm
- Dimensions
- 26” x 26 ½” x 39 3/8”
- Compliance
- GAMP5
- Operator Interface
- Intuitive HMI
- Pressure Vessel
- Robotically welded and polished
- Customizable Sizes
- Available upon request
- Working Mechanism
- Steam sterilization with autoclave
- Integrated Steps
- Cleaning and sterilization with flexible visualization
- CIP/SIP
- CIP 121°C / SIP 135°C
- Automation Level
- PLC with SIMATIC HMI
- Batch vs. Continuous Operation
- Batch
- User Friendliness
- Intuitive HMI with preset processes
- Energy Efficiency
- Optimized for productivity and efficiency
- Abrasion resistance
- Yes
- Biological compatibility
- Yes
- Cleanability
- High
- Corrosive resistance (e.g. acids)
- High
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Contamination prevention
- Biopharmaceutical production
- GMP Compliance
- Yes
- CE marking
- Yes
- FDA compliance
- Yes
- FDA materials
- Yes
- GAMP5 Compliance
- Yes
- Chamber size
- 0.4 to 9 cubic meters (10 to 400 cubic feet)
- Compact footprint
- Yes
- Control panel type
- Ergonomic display with intuitive HMI
- Discharge method
- Customizable to production setup
- Sanitary Design
- Sanitary stainless steel parts
- Control Panel Type
- SIMATIC HMI
- Integration Possibilities
- SIMATIC WinCC Unified
- Chamber Size
- 0.4 to 9 cubic meters
- Control System
- B,R,Siemens,Allen Bradley
- Customization Availability
- Autoclave Machine Fit