QUALIFICATIONS ACCORDING TO GMP
Annex 15 of the GMP states that:
“The manufacturer of process equipment must control critical aspects of the operations it implements through a qualification and validation program throughout the life cycle of the product and process.
Any planned changes to facilities, equipment, services and processes that may impact product quality must be formally documented and the impact on validation status or control strategy assessed. »
For this, STERIGENE has developed a team of validation managers and technicians specialized in the development of protocols according to current standards and specialized in qualification interventions for the process equipment of your production lines.
- Development of personalized protocols
- Teams of expert and specialized technicians
- Secure static and dynamic tests
- Equipment connected to international standards
- Summary file with recommendations
For your ZAC and clean rooms with STAURATEC
- Particulate controls
- Airflow measurements
- Clean room leak testing
- Filter integrity tests
- Aero-biocontamination
- Airborne surface disinfection
- FAT (Factory Acceptance Test)
- SAT (Site Acceptance Test)
- (Re)Installation Qualification (IQ)
- Instrumentation Calibration (CAL)
- (Re)Operational Qualification (OQ)
- Qualification of the steam profile according to EN285
- Performance Qualification (PQ)
- Autoclaves
- Washers
- Steam Generators, Thermocompressors and Distillers
- Candling table / Automatic or semi-automatic candling machines
- Filling machines and packaging equipment
- Isolators / Barrier Systems (RABS)
- Tanks
Why choose STERIGENE capitalizable FAT/SAT
FAT-compliant tests can be used for the SAT and SAT-compliant tests can be used for IQ/OQ qualifications
Reduction in downtime of process equipment and therefore reduction in costs.
