EtO Sterilization - DIN/EN 550 - ISO 11135

S

Shira

#11
Re: Gap analysis for ISO 11135-1994 and 2007

Thank you for the document, this is highly appreciated.
Shira
 
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M

microb7

#12
Re: Gap analysis for ISO 11135-1994 and 2007

Hello all,
I do not have a formal gap analysis, but I do have a lot of experience with EO sterilization validations. The main difference in the ISO11135 1995 to 2007 version is the addition of a requirement for a Fractional (Sub –lethal) Cycle to your validation runs. Also, this cycle has to be run at least every 24 months along with the annual re-validation. This is a cycle with a shortened EO dwell time duration (Less than a half-cycle time) when compared to the full cycle and with all other parameters constant. This cycle should produce biological indicator growth with no natural product sterility (NPS) growth and will be run to validate the biological recovery process as per ISO 11135-1: 2007. The involvement of this cycle is to fulfill the requirement to demonstrate that the natural product sterility (NPS) samples are less of a challenge to EO sterilization than the biological indicators (BI’s).
 

Doug Tropf

Quite Involved in Discussions
#13
Re: Gap analysis for ISO 11135-1994 and 2007

Hello all,
I do not have a formal gap analysis, but I do have a lot of experience with EO sterilization validations. The main difference in the ISO11135 1995 to 2007 version is the addition of a requirement for a Fractional (Sub –lethal) Cycle to your validation runs. Also, this cycle has to be run at least every 24 months along with the annual re-validation. This is a cycle with a shortened EO dwell time duration (Less than a half-cycle time) when compared to the full cycle and with all other parameters constant. This cycle should produce biological indicator growth with no natural product sterility (NPS) growth and will be run to validate the biological recovery process as per ISO 11135-1: 2007. The involvement of this cycle is to fulfill the requirement to demonstrate that the natural product sterility (NPS) samples are less of a challenge to EO sterilization than the biological indicators (BI’s).
Well said and welcome to the Cove.
 

medwise

Involved In Discussions
#14
Re: Gap analysis for ISO 11135-1994 and 2007

Hello all,
I do not have a formal gap analysis, but I do have a lot of experience with EO sterilization validations. The main difference in the ISO11135 1995 to 2007 version is the addition of a requirement for aFractional (Sub –lethal) Cycle to your validation runs. Also, this cycle has to be run at least every 24 months along with the annual re-validation. This is a cycle with a shortened EO dwell time duration (Less than a half-cycle time) when compared to the full cycle and with all other parameters constant. This cycle should produce biological indicator growth with no natural product sterility (NPS) growth and will be run to validate the biological recovery process as per ISO 11135-1: 2007. The involvement of this cycle is to fulfill the requirement to demonstrate that the natural product sterility (NPS) samples are less of a challenge to EO sterilization than the biological indicators (BI’s).
Hi microb7,

I am very naive to EtO sterilization. Can you please explain me what do you meant by " This cycle should produce biological indicator growth with no natural product sterility (NPS) growth and will be run to validate the biological recovery process as per ISO 11135-1: 2007"?

I am not familiar with the term natural product sterility.

Thanks

Kindest Regards,
Romit:)
 
S

Shira

#15
The meaning is that you should provide objective evidence that the challenge you are using has higher resistance than your product bioburden (i.e. product natural bioburden). If you are using a process challenge device (PCD) you should provide objective evidence that an External PCD (if used) is more resistant than Internal PCD, and that the internal PCD is more resistant than the inoculated product (at the worst case to sterilize locations), which has higher resistant than the natural product bioburden.

Hope it helps :)
 
P

phoexix

#16
Re: Gap analysis for ISO 11135-1994 and 2007

Hello all,
I do not have a formal gap analysis, but I do have a lot of experience with EO sterilization validations. The main difference in the ISO11135 1995 to 2007 version is the addition of a requirement for aFractional (Sub –lethal) Cycle to your validation runs. Also, this cycle has to be run at least every 24 months along with the annual re-validation. This is a cycle with a shortened EO dwell time duration (Less than a half-cycle time) when compared to the full cycle and with all other parameters constant. This cycle should produce biological indicator growth with no natural product sterility (NPS) growth and will be run to validate the biological recovery process as per ISO 11135-1: 2007. The involvement of this cycle is to fulfill the requirement to demonstrate that the natural product sterility (NPS) samples are less of a challenge to EO sterilization than the biological indicators (BI’s).
Hi Microb7, pls see below clause from 1994 version, what's your thought now?

c) When microbial identifications are not performed and the bioburden estimate is high: the
appropriateness of the biological indicator should be determined by exposure to sublethal (partial)
cycles. In these studies, the relative inactivation rates can be compared through testing.

A cycle of short duration from which survivors can be recovered should also be run to demonstrate the adequacy of the recovery technique.
 

harry

Super Moderator
#18
Dear All,

Any body have ISO 11137:2006 Version.

Thanks & Regards
Welcome to the Cove.

I believe some users here do have.

Not sure why you asked but sharing of copyrighted documents is strictly prohibited here. A good place to locate a copy for reference purpose would be your local university library.
 
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