Sterility test isolator for pharmaceutical processes
Ensure precise sterility testing with an isolator that maintains an aseptic environment, minimizing false results and safeguarding product integrity in demanding pharmaceutical applications.
Facilitates Aseptic Sterility Testing
The Telstar Pura from Telstar is a precision-engineered sterility test isolator designed to create a reliable aseptic environment. What sets the Pura apart is its robust bio-decontamination system using ionHP+ H2O2, ensuring rapid Log 6 bioburden reduction. This isolator is ideal for pharmaceuticals and biopharmaceuticals, particularly in sterility testing of products like sterile injectables and vaccines. It features PLC control with local HMI and SCADA packages for seamless operation, integrating easily with OEM and third-party equipment. Constructed from durable 316 stainless steel and toughened safety glass, the Pura meets strict ISO and GMP guidelines, making it suitable for Grade D cleanrooms and above. The system supports direct inoculation and filter membrane tests while providing reliable environmental monitoring. Assembly and manufacture are conducted in the UK, ensuring compliance and a high standard of quality. Configuration options allow personalization to meet specific production needs, helping you maintain stringent aseptic standards with ease.
Benefits
- Ensures product sterility by achieving consistent Log 6 bioburden reduction.
- Minimizes contamination risks with a reliable aseptic environment.
- Streamlines operations with PLC-controlled system and seamless integration.
- Complies with ISO and GMP standards, supporting pharmaceutical regulations.
- Offers versatile configuration options to suit specific production requirements.
- Applications
- Aseptic processes,Biopharmaceuticals,Sterility testing,Pharmaceuticals
- End products
- Vaccines,Sterile injectables,Monoclonal antibodies,Sterile ophthalmic solutions,Sterile intravenous fluids
- Steps before
- Preparation,Aseptic Setup,Decontamination,Environmental Monitoring
- Steps after
- Sterility Testing,Bioburden Reduction Validation,Documentation and Reporting
- Input ingredients
- pharmaceutical samples,test media,spore forming microorganisms,bioburden samples,H2O2 bio-decontaminant
- Output ingredients
- sterility tested samples,valid sterility test results,reduced bioburden,aseptic environment
- 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.
- Airflow type
- Unidirectional Grade A recirculatory airflow
- Pressure environment
- Positive pressure
- Bioburden reduction
- Log 6 reduction
- Bio-decontamination system
- Telstar’s ionHP+ H2O2 based
- Operating system
- PLC controlled with HMI and SCADA
- Material construction
- 316 Stainless steel and toughened safety glass
- Compliance
- ISO and GMP guidelines
- Cleanroom compatibility
- Grade D cleanroom background and above
- Environmental monitoring
- Viable / non-viable particles
- Airflow direction
- Unidirectional
- Airflow grade
- Grade A recirculatory
- Pressure environment
- Positive pressure
- Bioburden reduction
- Log 6
- Automation level
- PLC / SCADA
- Bio-decontamination system
- ionHP+ H2O2 based
- Compliance
- ISO / GMP
- Construction material
- 316 Stainless steel / Toughened safety glass
- Integration options
- OEM / 3rd party equipment
- Environmental monitoring
- Viable / Non-viable particles
- Cleanroom compatibility
- Grade D and above
- Corrosive resistance (e.g. acids)
- 316 Stainless steel
- Sterility Test Type
- Direct Inoculation / Filter Membrane
- ISO certification
- ISO 4.8
- ISO certification
- ISO 8 Cleanroom Classification
- Footprint
- Compact
- Construction Material
- 316 Stainless Steel
- Glass Type
- Toughened Safety Glass
- Number of Configurable Options
- Range of 5 standard isolators
- Airflow Type
- Unidirectional Grade A Recirculatory
- Pressure Type
- Positive Pressure Environment
- Control panel type
- PLC controlled
- Integration possibilities
- OEM / 3rd party equipment
- Construction materials
- 316 Stainless steel and toughened safety glass
- Environmental monitoring
- Viable / Non-viable particles