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Hello Everyone,
I have a question, can anyone please help me. we perform half cycle validation (Eto) every two year and always get satisfactory result. in 2012, we performed fractional cycle (Validation Eto) where timing was for 5 minutes.
Out of 9 samples, 3 samples were failed.
How can we proved that PCD (Biological indicator 'Bacillus stearothermophilus') is more resistance to product (Product bio burden is always more than 100 cfu/item).
Can anyone please help me how can i justify that PCD is more resistance to product without repeating fractional cycle
Thanks in advance
I have a question, can anyone please help me. we perform half cycle validation (Eto) every two year and always get satisfactory result. in 2012, we performed fractional cycle (Validation Eto) where timing was for 5 minutes.
Out of 9 samples, 3 samples were failed.
How can we proved that PCD (Biological indicator 'Bacillus stearothermophilus') is more resistance to product (Product bio burden is always more than 100 cfu/item).
Can anyone please help me how can i justify that PCD is more resistance to product without repeating fractional cycle
Thanks in advance