Hi bio_Subbu,
I am aware of the current regulation. Was just curious to know the difference between the 1994 version and 2007 version of ISO 11135.
Regards
Romit
Hi bio_Subbu,
I am aware of the current regulation. Was just curious to know the difference between the 1994 version and 2007 version of ISO 11135.
Regards
Romit
B
babarian
Hi bio_Subbu,
I am aware of the current regulation. Was just curious to know the difference between the 1994 version and 2007 version of ISO 11135.
Regards
Romit
Hi, Romit:
at least there are three substaintial change:
1. apply design for sterilization process. and steriliztion process need design consideration and control now.
2. new standards applied to more scope, e.g. cover the applicaiton in hospital, and more flexible, e.g. many review is accept now.
3. need more humidity monitoring and control, and more explosion-protected humidity sensors were needed now.
best regards,
fan, tao
E
emansaad
Dear ALL,
I am a naive with eto validation but i read ISO 11135 and some other references, but i have some question, if anyone can help , i will be grateful..
1- on what basis, we calculate the fractional cycle time and half cycle time?
we use mixture from EO 20% and CO2 80% in our sterilizer and i read on BI box the following data
1.4 x 10e6 per strip
ETO 600mg/l , temp 54 celisus and 60%RH
D value is 4 minutes
survival time is 16.6 minutes
kill time is 40.5 minutes.
so how can i use these data to calculate half time and fractional time????
taking into consideration that
the difference in total pressure in our sterilizer is 2.47 kg/cm2
and the temperature is 50 +/- 5 celisus
I am a naive with eto validation but i read ISO 11135 and some other references, but i have some question, if anyone can help , i will be grateful..
1- on what basis, we calculate the fractional cycle time and half cycle time?
we use mixture from EO 20% and CO2 80% in our sterilizer and i read on BI box the following data
1.4 x 10e6 per strip
ETO 600mg/l , temp 54 celisus and 60%RH
D value is 4 minutes
survival time is 16.6 minutes
kill time is 40.5 minutes.
so how can i use these data to calculate half time and fractional time????
taking into consideration that
the difference in total pressure in our sterilizer is 2.47 kg/cm2
and the temperature is 50 +/- 5 celisus
Doug Tropf
Quite Involved in Discussions
I would suggest you have a look at AAMI TIR16:2009, "Microbiological aspects of ethylene oxide sterilization".
E
emansaad
Thank u for ur replay but, the company does not have this standard yet, and it will consume sometime to buy this std. so do u have any other information regarding this topic which u can tell me for now?
thx again
thx again
E
emansaad
another question , which should be done first ? fractional cycles or half cycles?
Doug Tropf
Quite Involved in Discussions
The TIR can be purchased on-line and downloaded in PDF format at the AAMI website.
Doug Tropf
Quite Involved in Discussions
Depending on your approach, see Annex A or B of 11135-1:2007.
A
Aqeel Abbas
Hi,
First of all, I reiterate the fact that I love this educational forum and the huge amount of guidance provided by so many devoted people.
We are in the process of performing Sterilization Process Validation and compiling the report. We are subcontracting the ETO Sterilization services from a local vendor who is certified for ISO 13485. I understand that as such we only have to develop and validate a suitable sterilization cycle and to perform Performance Qualification. I need a brief guidance on to what extent we need to include the IQ and PQ details in our report. Does the fact that the vendor is ISO 13485 certified sufficient to skip too much IQ and PQ details?
I will appreciate if a detailed reply can summarize what needs to be covered and most importantly, how?
A sample validation report of such a situation is also appreciated.
Thanks in anticipation.
First of all, I reiterate the fact that I love this educational forum and the huge amount of guidance provided by so many devoted people.
We are in the process of performing Sterilization Process Validation and compiling the report. We are subcontracting the ETO Sterilization services from a local vendor who is certified for ISO 13485. I understand that as such we only have to develop and validate a suitable sterilization cycle and to perform Performance Qualification. I need a brief guidance on to what extent we need to include the IQ and PQ details in our report. Does the fact that the vendor is ISO 13485 certified sufficient to skip too much IQ and PQ details?
I will appreciate if a detailed reply can summarize what needs to be covered and most importantly, how?
A sample validation report of such a situation is also appreciated.
Thanks in anticipation.
T
The Specialist
The validation report should include the following:
· References to the following:
URS
VP/VMP
RA (if not included in VP)
IQ
OQ
PQ
· Revision History
· Contents list
· Validation Status Summary
· Introduction
· Equipment Description
· System Process Flow
· Documentation review (SOPs/Maintenance and calibration schedules/O&M manuals etc)
· Validation Review (to include):
· List of tests conducted at IQ
· List of tests conducted at OQ
· List of tests conducted at PQ
· (indicate Pass/Fail Result and record deviations and deviation status)
· Gap analysis (against RA/test requirements/user requirements)
· Conclusion
· References to the following:
URS
VP/VMP
RA (if not included in VP)
IQ
OQ
PQ
· Revision History
· Contents list
· Validation Status Summary
· Introduction
· Equipment Description
· System Process Flow
· Documentation review (SOPs/Maintenance and calibration schedules/O&M manuals etc)
· Validation Review (to include):
· List of tests conducted at IQ
· List of tests conducted at OQ
· List of tests conducted at PQ
· (indicate Pass/Fail Result and record deviations and deviation status)
· Gap analysis (against RA/test requirements/user requirements)
· Conclusion
