1.1 The production of sterile preparations should be carried out in clean
areas, entry to which should be through airlocks for personnel and/or for
equipment and materials. Clean areas should be maintained to an appropriate
standard of cleanliness and supplied with air that has passed through fi lters
of the required effi ciency.
1.2 The various operations of component preparation (such as those
involving containers and closures), product preparation, fi lling and
sterilization should be carried out in separate areas within the clean area.
These areas are classifi ed into four grades (see section 4).
1.3 Manufacturing operations are divided here into two categories:
— fi rst, those where the product is terminally sterilized; and
— second, those which are conducted aseptically at some or all stages.
Continue at: http://www.who.int/medicines/areas/quality_safety/quality_assurance/GMPSterilePharmaceuticalProductsTRS961Annex6.pdf
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