The pharmaceutical manufacturing environment at BPL is based around a series of rooms with specially controlled environments. These are termed ‘clean rooms’. Aclean room or zone, on one level, is simply is a room that is clean. The key aspect,however, is that the level of cleanliness is controlled.
A more specialised meaning is:
A more specialised meaning is:“A room with control of particulates and set environmental parameters. Constructionand use of the room is in a manner to minimise the generation and retention of particles. The classification is set by the cleanliness of the air” (as defined in ISO14644-1).
By prescribing a grade or a class to a clean room, the areas are then regarded ascontrolled environments. A controlled environment is:
“Any area in an aseptic process system for which airborne particulate andmicroorganism levels are controlled to specific levels to the activities conductedwithin that environment” (Institute of Validation Technology Dictionary).For more information concerning the physical operation of cleanrooms, refer to theHVAC fact-sheet.
Cleanrooms are designed to minimise and to control contamination. There are manysources of contamination. The atmosphere contains dust, microorganisms,condensates, and gases. Manufacturing processes will also produce a range of contaminants. Wherever there is a process which grinds, corrodes, fumes, heats,sprays, turns, etc., particles and fumes are emitted and will contaminate thesurroundings.
People, in clean environments, are the greatest contributors to contamination emitting body vapours, dead skin, micro-organisms, skin oils, and so on. The average personsheds 1,000,000,000 skin cells per day, of which 10% have micro-organisms on them.This demonstrates the importance of wearing cleanroom clothing and wearing thisclothing correctly.
Most cleanroom micro-organisms are in the air. If they settle on a dry surface they areunlikely to survive and ideally any contamination is removed from the room. The biggest concern is water, which is both a vector and a growth source for micro-organisms.
Second to people, the key contamination source is water. This is a continuing issue aswater is the main ingredient in BPL products, and it is used widely throughout themain process areas.