Sterility test isolators for continuous batch testing
Ensure aseptic integrity during high-throughput sterility testing with double-chamber isolation, allowing continuous batch processing and simultaneous decontamination of new samples.
Ensures Sterility in Pharmaceutical Testing
The Pura 2+ Sterility Test Isolators from Telstar are engineered for pharmaceutical and biotechnology sectors, offering a double-chamber system for continuous sterility testing. The isolators maintain Class ISO 5 (Grade A) air cleanliness, vital for injectable vials and lyophilized pharmaceuticals. These units facilitate controlled sterility testing through a positive-pressure environment and integrated HP+® bio-decontamination, ensuring process integrity. Designed for flexible operations, they allow additional materials to be bio-decontaminated in a transfer chamber while ongoing tests continue in the main chamber. The Pura 2+ prioritizes contamination-free environments with H2O2 monitoring and rigorous glove testing. Fully compliant with GMP standards, it is an ideal choice for manufacturers seeking reliable sterility assurance in batch and continuous production settings.
Benefits
- Enhances sterility assurance in pharmaceutical testing, minimizing contamination risks.
- Supports continuous production with dual chambers, reducing process interruptions.
- Maintains Class ISO 5 air quality for optimal product integrity.
- Ensures regulatory compliance with GMP standards, facilitating hassle-free audits.
- Streamlines testing processes with seamless material transfer and decontamination capabilities.
- Applications
- Aseptic pharmaceuticals,Injectable products,Sterile products,Biopharmaceuticals,Hygroscopic products,Pharmaceuticals
- End products
- Pre-filled syringes,Lyophilized pharmaceuticals,Sterile eye drops,Injectable vials
- Steps before
- Sample preparation,Bio-decontamination,Pre-loading samples,Transfer chamber preparation
- Steps after
- Bio-decontamination of additional materials,Packing,Final quality control
- Input ingredients
- initial samples,test materials,additional test materials,additional samples
- Output ingredients
- sterility test results
- Market info
- Telstar is known for specializing in the design, engineering, and manufacturing of advanced vacuum and aerospace solutions, gaining a strong reputation for their innovative and customized equipment in pharmaceutical, medical, and scientific research sectors.
- Internal Air Cleanliness
- Class ISO 5 (4.8)
- Pressure Environment
- Positive (+ve)
- Sterility Test Pump
- Double Filter
- Bio-decontamination Method
- H2O2
- Instrument Control
- HP+® Generator
- Monitoring
- Non-Viable and Viable Monitoring
- Air cleanliness class
- ISO Class 5 (4.8)
- Batch testing capability
- Continuous batch testing
- Automation level
- Includes HP+® Generator and monitoring
- Pressure environment
- Positive pressure
- Sterility maintenance
- Transfer chamber for bio-decontamination
- Glove integrity testing
- Telstar Glove Tester
- Non-viable and viable monitoring
- Included
- Double chamber system
- Yes
- Internal shelving options
- Trolley/Racking/Shelving
- Year of implementation
- 2020
- ISO 14644-1
- ISO 5 (Grade A)
- Glove Tester
- Telstar Glove Tester
- Non-Viable Monitoring
- Available
- Viable Monitoring
- Available
- Trolley/Racking/Shelving
- Customizable