Isolator Qualification and Validation Services
Cape Europe has extensive experience in isolator and controlled environments qualification and have qualified and validated over 75 major isolator installations since the company was created in 2005 covering applications such as Aseptic Filling, Sterility Testing, Transfer hatches and chambers, Dispensing and Formulation:
We offer the following isolator qualification and validation services:
- Preparationof User specifications,
- Commissioning and pre-qualification testing (Factory trails, FAT), GAMP analysis,
- Preparation of SAT,IQ/OQ/PQ protocols,
- SAT,IQ/OQ/PQexecution,
- HAZOP and Failure mode analysis,
- Training and Customer assistance for PQ execution,
- Operator training and qualification,
- Streamlined "fast track" qualification for "standard" applications,
- Retrospective qualification services,
- Environmental monitoring programs,
- Annual maintenance, calibration and Re-qualification.
The company has an extensive range of specialised test equipment. All our reference instruments are calibrated to ISO standards.
Typical set up for isolator qualification.
HEPA filter integrity testing upstream challenge
OQ testing
Sterility test isolator environmental monitoring post VHP bio-decontamination cycle qualification
Filling line isolator environmental monitoring post VHP bio-decontamination cycle qualification
Filling line isolator environmental monitoring post VHP bio-decontamination cycle qualification