Clean rooms
Classification and requalification of clean rooms, laminar flow units, isolators and biosafety cabinets.
| Test | Reference |
|---|---|
| Particle counting and classification, at rest and in operation | ISO 14644-1 |
| Air velocity and airflow volume | ISO 14644-3 |
| Air change rate | ISO 14644-3 |
| Pressure differences | ISO 14644-3 |
| HEPA filter leak test | ISO 14644-3 |
| Recovery time | ISO 14644-3 |
| Active microbial air sampling | EU GMP Annex 1 |
Smoke studies
Airflow visualisation at critical points: filling, transfers, glove ports, doors. At rest and in operation, with routine and corrective interventions.
- WFI fog for grade A areas, or oil fog
- DJI Osmo cameras in a multi-view setup, videos indexed by sequence
- Assessment report; options: video editing and video analysis
References: EU GMP Annex 1 (2022), ISO 14644-3.
Thermal validation
Temperature, humidity and CO₂ mapping; heat distribution and heat penetration.
- Cold storage: fridges, freezers down to −80 °C, cold rooms, blast freezers
- Liquid nitrogen storage and controlled-rate freezers
- Incubators (temperature, humidity, CO₂) and stability chambers
- Clean rooms, storage rooms and warehouses
- Autoclaves, depyrogenation tunnels, freeze dryers, SIP of vessels
Empty and loaded runs, door opening, power failure and recovery. Loggers and thermocouples are checked before and after each campaign.
Cleaning validation
- Riboflavin coverage tests of spray devices, washers and tanks, with UV inspection and photos
- Point-of-use conductivity and TOC for rinse monitoring
Calibration and rental
On-site verification of temperature, humidity, pressure, differential pressure and airflow sensors against traceable references. ISO/IEC 17025 accredited calibration through a partner laboratory, on request.
Rental: our measuring instruments by the day, checked before and after each rental.
Consulting and training
- Technical assistance: an engineer in your project for a set period
- Training in GMP, metrology and qualification topics, on site or remote
Prices
Prices on request. Each quotation states the scope, the tests and the price: a fixed price per job, or time and materials. CHF, excluding VAT.