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Pharmaceuticals/Hold Time for new facility

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Question
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?

Answer
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

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