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Pharmaceuticals/Cleaning validation for drugs


QUESTION: How should We validate the intervals between use and cleaning as well as cleaning and reuse for oral drugs.

We can easily find the methods of the cleaning validation but no about the interval.

Please someone teaches me your experience.

ANSWER: Higashimori-san:

1. Determine the maximum period you want to allow equipment to sit in a "dirty" (used) condition. For example if you use the equipment on a Friday afternoon, but cannot clean it until Monday afternoon, then you need to validation a 72 hour maximum "dirty hold" time.

2. When you perform your cleaning validation, use the equipment with your hardest to clean product. Then wait for 72 hours before starting the cleaning cycle you are trying to validate.

I hope this helps.

---------- FOLLOW-UP ----------

QUESTION: Dear Mr. Michael Anisfeld,

Thank you for replying to my inquiry. This is understandable and useful information. But one more question is emerged in mind.
How should we evaluate or measure cleanness 72 hours later after cleaning. Residue active ingredient, dust or falling bacteria?

It would be appreciated if you could answer to my question.


If you have shown that the cleaning has been effective, then if you seal the equipment that has been cleaned, you should have no residue to worry about - so I am sorry but I do not understand your chemical concerns.

However from a microbial consideration you do need to perform a "clean hold time" study to answer the question of how long can the equipment remain clean before use.


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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