Manufacture of sterile preparations
Classification of clean areas
Manufacturing operation in an appropriate environment cleanliness level
Minimize risks - particulate and microbiological contamination - product and material
Meet classification "at rest"
- (That is "completed installation, equipment installed and operating, but no operating personnel present")
During the inspection, you have to verify that the operations for the manufacture of sterile products are carried out in the correct grade or class of air.
Precautions should be taken to prevent possible contamination with particulate matter and microorganisms. This applies to products, materials including primary packaging materials.
The manufacturer should demonstrate that the areas meet the required classification, This must be done through monitoring including particles and microorganisms. Normally, this is done while the area is "at rest". Monitoring should also be done during operations.