Sterility testing isolator for aseptic environments
Ensure aseptic conditions and process integrity during sterility testing with an isolator designed for precise decontamination and controlled environments, essential for safeguarding sensitive pharmaceutical and biotech production.
Ensures Sterility in Testing Environments
The Sterility Testing Isolator from Fabtech Technologies is engineered for pharmaceutical, biopharmaceutical, and healthcare industries, offering a controlled aseptic environment for sterility tests and bio-decontamination processes. Constructed with durable SS 316L, it features ISO 5 Grade A laminar airflow, ensuring an ultra-clean workspace. Its standard setup includes a pass box with dual glove ports, a main chamber with quad glove ports, and a glove integrity tester, accommodating both manual and high-speed operations. Compatible with VHP decontamination, the isolator supports on-demand process equipment and particle counter integration, enhancing operational efficiency. Opt for multiple chamber configurations to tailor the isolator to your production needs. With password-protected authorization levels, it adheres to stringent compliance requirements, making it ideal for sterility testing of vaccines, monoclonal antibodies, and sterile medical devices.
Benefits
- Maintains aseptic conditions to minimize contamination risks in sterile drug production.
- Enhances operational efficiency with customizable chamber configurations and glove integrity testing.
- Integrates seamlessly into existing production lines with on-demand equipment and particle counter options.
- Supports compliance with ISO 5 Grade A classification for pharmaceutical and biotech applications.
- Provides enhanced security and process control with multi-level password-protected access.
- Applications
- Biopharmaceuticals,Healthcare products,Pharmaceuticals
- End products
- Sterile injectable drugs,Vaccines,Monoclonal antibodies,Sterile medical devices,Aseptic pharmaceutical formulations
- Steps before
- Aseptic Preparation,Product Load,Environmental Monitoring
- Steps after
- Product Removal,Sterility Confirmation,Decontamination
- Input ingredients
- VHP for decontamination,H2O2 decontamination,Sterility test samples
- Output ingredients
- Aseptic environment,Decontaminated process equipment,Sterility test results
- Market info
- Construction Material
- SS 316L
- Airflow Classification
- ISO 5 Grade A
- Glove Ports
- Main chamber
- Decontamination Method
- VHP compatible,H2O2 optional
- Ergonomics
- Customizable
- Configuration Options
- Multiple chambers
- Process Equipment Integration
- On-demand
- Particle Counter
- Online integration
- Authorization Levels
- Password protected
- Working Mechanism
- Aseptic Environment with VHP Decontamination
- Automation Level
- PLC Controlled
- Cleaning Method
- H2O2 Decontamination Optional
- Batch vs. Continuous Operation
- Batch
- Glove Integrity Tester
- Standard Inclusion
- Customization Options
- Multiple Chamber Configuration
- Authorization Levels
- Password Protection
- Airflow Control
- Laminar Airflow ISO 5 Grade A
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- ISO Standards
- ISO 5 Grade A classification
- Footprint
- Customizable per client requirement
- Material construction
- SS 316L
- Chamber configuration
- Multiple chamber options available
- Glove Ports
- Pass Box (2 Glove Ports),Main Chamber (4 Glove Ports)
- Customizable ergonomics
- Yes
- Integration options
- Process equipment and online particle counter
- Airflow classification
- ISO 5 Grade A
- Material
- SS 316L
- Ergonomic design
- Customizable
- Chamber configuration
- Multiple options
- Glove ports
- 2 and 4
- Decontamination option
- H2O2 / VHP
- Pass Box
- Standard
- Password protection
- Multiple authorization levels
- Online particle counter integration
- Included
- Process equipment integration
- On-demand