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how can we decide the limit of cleaning validation? What is
the criteria for it?
- 2 Answers
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Answer / ramana reddy
limit of cleaning validation shall be calculated by
considering worst case product based on the least
solublity, therapeutic dose and toxicity of the product.
The criteria for calculating the cleaning validation is of
both DOSE criteria and 10 PPM criteria.
| Is This Answer Correct ? | 19 Yes | 3 No |
Answer / naveen
limit of cleaning validation shall be calculated by
considering worst case product based on the hardest to clean ,least
solublity, therapeutic dose and toxicity of the product.
The criteria for calculating the cleaning validation is of
both DOSE criteria and 10 PPM criteria
| Is This Answer Correct ? | 0 Yes | 1 No |
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