Sterility testing isolator

Isolators designed to ensure sterile and high-containment environments in critical pharmaceutical operations. GMP/cGMP compliance and bespoke solutions for API handling, sterility testing and sensitive products. They can be customised and tailored to ensure the prevention of all contamination risks, provide perfect product containment and protect personnel during handling operations in research centres and pharmaceutical industry laboratories.

Main applications:

• Aseptic handling of active ingredients and sterile formulations.
• Safe preparation and transfer of critical materials.
• Microbiological testing and quality control.
• Processes involving chemical or biological risks (cytotoxic substances, HPAPI, viruses, bacteria).
• Bio-decontamination of materials and equipment prior to entry into cleanrooms.
• They comply with GMP, cGMP and ISO standards, as well as the specific requirements of cleanrooms and other controlled environments.

General Specifications:

• Ventilation System ETF (Engineered Turbulent Airflow)
• UDAF (Unidirectional Airflow)
• Filtration by HEPA filters H14 or ULPA U15
• Regulated pressure positive or negative
• RTP Rapid Transfer Port for waste management (solid and or liquid)
• Microbial Air Sampler integration as option for environmental monitoring
• Particle Counter integration for environmental
• Sterility pump integrated (mechanical and electrical integration)
• H2O2 sensors for the concentration measurement inside the isolator during the process
• H2O2 sensor for the concentration measurement in the room (operator safety)
• GLT Glove Leak Tester – Integrate or with dedicated software interface

– Containment and controlled environment system to protect the product (sterility), the operator (containment) and the workplace (to prevent the release of hazardous agents).
– Sterility testing and microbiological monitoring.
– Decontamination of materials and components using H₂O₂ or PAA.

BPF, cGMP, ISO & PIC/S

Consult