how can we decide the limit of cleaning validation? What is
the criteria for it?
Answers were Sorted based on User's Feedback
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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My question about gas chromatography sulfur chemiluminsecence detector. I test unknown sample gas by GC-SCD (calibrated ) and the result of *H2S is 279 PPM , *but when I test the same sample with the GC-TCD (calibrated ) the value of *H2S is 2500 PPM . I'd like to inform you that both GCs are calibrated and have very good operation conditions with stable parameters . the question is if the sample gas with higher H2S over detection limits of SCD detector (1000 ppm). why the result it 279 ppm Best regards