Fractional cycle fail in Eto sterilization validation

S

sushil khatri

#1
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
 
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M

MIREGMGR

#3
Can anyone please help me how can i justify that PCD is more resistance to product without repeating fractional cycle
You cannot so justify. The performed test showed that the PCD is not more resistant.

The test did what it was supposed to do. Your next move might be to develop a different PCD that is harder to sterilize and therefore can be shown in a fractional test to be more challenging than the product.

As a side note: you say
Product bio burden is always more than 100 cfu/item
That's a problematic comment because sterilization validation requires that an upper, not lower, bound be established for bioburden quantity (as well as bioburden type/variety being known constant) so that it is known that production sterilization will be less, not more, challenged by bioburden conditions than was the case during validation.
 
Last edited by a moderator:

Qara123

Involved In Discussions
#4
Hi Sushil,

Two questions.

1. You use an ethylene oxide sterilization process, why are you using Bacillus stearothermophilus as your biological indicator?

2. Is your fractional cycle a 1/2 cycle to validate an overkill method or to demonstrate that your PCD is more resistant than your product bioburden (i.e., less than 1/2 cycle)?

Purpose of fractional cycle may be to obtain BIs which are still alive and products which are sterile. This is to show that your PCD is more difficult to kill than bioburden found on your products. This is different from the overkill method where the objective is to make sure all BIs are dead.

Q
 
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