Appendix 15 of the GMP states that:
“The process equipment manufacturer must control the critical aspects of the operations it implements by means of a qualification and validation programme throughout the product and process life cycle.
Any planned changes to facilities, equipment, services and processes that may affect product quality should be formally documented and the impact on validation status or control strategy assessed.”
Download the Qualification/Validation documentation
STERIGENE performs your qualifications/validations according to your current standards.
- Creation of customised protocols
- Secure static and dynamic tests
- Equipment in line with international standards
- Summary file with recommendations
For your CAAs and cleanrooms with our partner Clean Air Technologies.
- Particulate controls
- Air flow measurements
- Leak tests in cleanrooms
- Filter integrity tests
- Aerobiocontamination
Available qualifications/validations:
-
FAT/SAT
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Installation (re)qualification
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Instrument calibration
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Operational (re)qualification
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Steam profile qualification according to EN285
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Performance qualification
Concerned equipment:
- Autoclaves
- Washers
- Steam generator
- Distiller
- Visual inspection table
- Thermostatically-controlled areas (ovens, cold rooms, etc.)
- Tanks
- Packaging equipment
Why choose STERIGENE capitalizable FAT/SAT?
FAT-compliant tests can be capitalised for the SAT, and SAT-compliant tests can be capitalised for IQ/OQ
qualifications
Reduction of process equipment downtime and therefore costs.
