Production in clean areas
Appropriate standard of cleanliness
Filtered air supplied
Airlocks for entry
- personnel and/or equipment
Separate areas for operations
- component preparation (containers and closures)
- product preparation
- filling, sterilization, etc.
A general requirement for the manufacture of sterile products, is that production must be done in clean areas. The manufacture of the products should take place in areas of appropriate standards of cleanliness. We will go into more details on this later. The areas should have air supplied through appropriate filters e.g. HEPA filters.
Entry to these areas are through airlocks for personnel and/or equipment, and airlock for goods or materials.
There are different operations to be carried out. This includes component preparation, product preparation and filling. Separate areas for these operations are needed.