Isolator (barrier) technology has become a preferred option for many industries committed to control of cleanliness and is widely used in many hospitals, healthcare and pharmaceutical companies who have realised the potential benefits of Pharmaceutical Isolators.
Our experience and expertise in the validation testing of isolators means you can be assured of a comprehensive testing programme to evaluate the performance of your Isolator and appropriate routine testing to prove its continued compliance with national standards, industry guidelines and cGMP’s.
- Air velocity uniformity, air volume and breach velocity measurements
- Air pressure differential measurements
- HEPA filter integrity leak tests
- Airborne particulate cleanliness counts
- Clean-up recovery rate tests
- Airflow visualisation studies
- Pressure decay and construction integrity tests
- Light and noise level; measurements
- Cabinet function and pre-filter checks
- Alarm and warning system checks
All test are carried out in accordance with client requirements. Validair’s operating procedures and with reference to national, international and industry standards and guidelines.
Full comprehensive validation reports are issued following each visit and provide a valuable record of performance levels for the Isolator and build up to comprehensive documentary evidence of cleanroom performance and trends. Satisfying auditor requirements such as MHRA, FDA, internal or external client audits.
All these tests can be executed at the cabinet manufacturer premises as well as on site, during the initial commissioning period and also as part of the ongoing maintenance.