Cleaning Validation – Visual Inspection and Quantitation

Consideration of the following is suggested as part of the development of a
manual cleaning methodology:
- The inspection of major equipment following or during manual
cleaning should take place prior to the analytical rinsing or swabbing
to provide a greater probability that target residues are removed prior
to sampling.
- The inspection should not substitute for the final visual inspection that
would typically take place following analytical sampling. The final
visual inspection determines the success or failure of the validation
execution.
- For those areas that will be inspected again for final determination of
visual cleanliness, this in-process inspection may be less stringent than
the final visual inspection. For instance, flashlights and mirrors might
not be necessary, complete absence of visible residues might not be
required, and complete disassembly of equipment might not be
justifiable. The justification for this approach being that this type of
inspection is not the final inspection and once a residue has been acted
upon in some manual manner (e.g., scrubbing, power washing) it is
more likely to be effectively removed subsequently by the CIP system.
- The inspection is at the discretion of the process designer(s) and is not
required. The purpose of inspection after manual cleaning is to
measure the effectiveness of the manual methodology before resuming
CIP cleaning. It might not be justified for example, if the manual
methodology has been shown to be rugged in the past, or is simply a
precautionary measure to provide a greater probability of passing
acceptance criteria at the conclusion of the cleaning process.
Inspection of equipment that is cleaned manually and can be 100% visually
inspected prior to release back to production (e.g., mills and minor equipment)
is not the subject of this specific section. Rather, the inspection of these
examples should follow the guidance of 􀂳final visual inspection􀂴 detailed
below.
2 (a). Visual Inspection of Dedicated Equipment 􀂱 Interval Cleaning:
Interval cleaning, or cleaning processes that take place within a campaign of
the same product, are appropriate when an evaluation of the material being
cleaned has been completed and there are no quality concerns (e.g.
degradation of material) about carryover of some amount of one batch into the
next batch.
Although the intent of this section of the procedure is focused primarily on
dedicated equipment it may also be applied to interval cleaning that takes
place between batches within a campaign using multi-purpose equipment.

No comments: