When examining equipment for types of residue, it is important to remember that the equipment itself should not contribute contaminating agents.
Lubricants, surface coatings and sealants must all be reviewed during the equipment design so that they present no danger in leaving behind residues that will adulterate products.
For sterile products, the operation of the equipment during cleaning should
not generate particulates.
In keeping with CGMPs, equipment must be non-porous, non-reactive,
non-additive and non-adsorptive.
For non-aqueous processes where water is used in cleaning, it may be necessary to validate post cleaning drying periods.
The presence of residual water after cleaning may result in microbial or
endotoxin contamination.
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