Validation - Qualification
Our twenty years of experience allow us to offer validation and qualification services to support our clients’ business during audits carried out by regulatory agencies such as the FDA or the AIFA, in order to ensure the compliance with EU-GMP and ISO standards for:
Equipment (apparatus and instruments)
Systems (combination of apparatus and instruments)
Manufacturing processes (combination of operations required for manufacturing)
Controlled-contamination areas (cleanrooms)
Main activities
We provide HVAC aeraulic balancing, testing, qualification and commissioning of:
Controlled-contamination areas, cleanrooms and isolators
Contamination monitoring services | At rest and operational smoke studies
One-way flow modules, fume hoods and safety weighing cabinets/integrity testing of HEPA absolute filters
Warehouses, stability chambers, freezers, incubators, cryostats and cryo-blood banks, T/%RH mapping
Laboratory and monitoring instruments
Portable microbiological samplers with specific Data Integrity protocols | pH-meters | Conductivity meters | Balances | Micropipettes
