Clean areas for the manufacture of sterile products are classified according to the required characteristics of the environment. Each manufacturing operation requires an appropriate environmental cleanliness level in the operational state in order to minimise the risks of particulate or microbial contamination of the product or materials being handled.
Clean rooms and clean air devices should be classified in accordance with EN ISO/GOST 14644-1. They must be qualified and regularly re-qualified, whereby a number of parameters are measured/tested, such as air-borne particles content, temperature/humidity, air-exchange rate, integrity of HEPA Filters etc.
Pharma Group Baltic has qualified specialists and necessary measuring equipment that allows to perform all required tests/measurements in accordance with EN ISO/GOST 14644-3:
Air supply / exchange rate
Static differential pressure
HEPA filters integrity test (“DOP/DEHS” test with a modern harmless aerosol substance PAO)
Grade confirmation test (air-borne particles content)
Pharma Group Baltic has also equipment for the determination of oil and dew point (moisture content) in Compressed Air (CA) systems.