Cleaning of Equipments
The equipments to be used in the processing of the sterile products must be thoroughly cleaned. The new and unused equipments are contaminated principally with dust, fibers, and chemical films which usually are relatively easy to remove often by rinsing only.
Debris that is more dangerous and more difficult to remove may be present as residue form the previous use. These are removed by vigorous treatment with hot detergents.
Whenever possible, large equipments should be disassembled so that each part can be thoroughly scrubbed and clean with particular attention given to screw threads, joints and other dirt collecting structures. After cleaning, the equipments should be rinsed several times with final rinse with water for injection (WFI). Just prior to re-use, large cleaned tanks and similar equipments should be rinsed thoroughly with WFI. Reserving of the equipment for use with only one type of the product reduces the cleaning problems.
A new method for large tanks, pipe lines and associated equipments that can be isolated and contained within a process unit has been developed and identified as clean in place
(CIP) system. Under this system, cleaning of the dedicated instruments for specific products is accomplished primarily with high pressure rinsing treatments, delivered automatically within the equipment. This is usually followed by steam sanitization through the same system.
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