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Pharmaceuticals/Hold Time for new facility


We have a new facility, wherein we are starting manufacturing of products as exhibit. Multiple products to be manufactured and after each batch of each product we have to wait for receipt of results and hence, possible delay between two batches of 24-72 hrs.

As we do not have DEHT & CEHT, what minimum is acceptable as initial for new facility till we establish? Any reference?

Why do you need to wait up to 72 hours between batches? Makes no sense.

You need to perform cleaning validation for your worst case product (which includes a 72hr. hold time) to show that your standard cleaning method effectively cleans your equipment. Then as soon as you have emptied the equipment, clean using your validated cleaning SOP, and proceed with the next batch.

For the best guideline on how to do all this (including DEHT/CEHT) Google "Canada cleaning validation" and download the world's easiest to understand cleaning validation guideline


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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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