What needs to be understood by the same cleaning procedure. Does this mean that operations must be step by step the same? what are the criteria for classifying two equipments in the cleaning procedure. Can anybody give me references to clarify that?
I assume you are talking about manual cleaning operations. For automatic cleaning operations, each cycle will be qualified.
Here are a few cleaning methods:
- COP (soak or spray bath)
- Parts Washer
For manual cleaning operations some of the factors that would be part of “same cleaning procedure” would be:
- Same cleaning agent/solution
- Same personnel
- Same environmental cleaning conditions
- Same dirty hold time, same clean hold time
- Same cleaning utensils/tools used (same brushes, poles, extensions)
- Same pressure washers (if used)
- Same temperature of cleaning solution.
- Same cleaning time
- Same number of scrub passes.
Thank you JaredCroft,
It is about manual cleaning operation. I try to group the equipment according to their cleaning procedure. Some stage as the disassembly of certain piece of equipment are different from one equipment to another. These differences are to be taken into account in the grouping of the cleaning procedures, or is it enough that the parameters that you mentioned are the same to have the same cleaning procedure?
So you disassemble and clean at different times? Is that what your last comment indicated?
If so, then during cleaning validation your worst case is whatever had the longest “dirty hold time”. You should exceed the expected hold time during production, when you are validating.