ISO 11135 Monitoring Routine ETO Sterilisation Parameters

Nash27

Involved In Discussions
#1
Hi All,

Just wondering if someone could suggest the ETO parameters to monitor as part of the routine ETO sterilsaition. One of our lower class device is outsourced to the contract manufacturer, the contract manufacturer shall also perform ETO sterilisation process (in-house). The ETO process is validated.

What parameters should we need to monitor for routine ETO sterilisation process to demonstrate control over contract manufacturer. What I am trying to do is, set an excel based register and for each lot record the important ETO paramaters supplied by the contract manufacturer. This register then can be evaluated for trend. However not sure what parameters I should include in this excel based register.

Any comments, suggestions would be much appreciated. Thanks
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Re: ISO 11135 Monitoring routine ETO Sterilisation

Hi Nash27,
During routine sterilization what is usually being tested is LAL and BI.
From my experience what you get from the sterilization sub-contractor includes checklists, QC Form, QC report, chamber parameters with test results, and images of package and box labels.

Hope it helps.

Shimon
 

Nash27

Involved In Discussions
#4
Re: ISO 11135 Monitoring routine ETO Sterilisation

Hi Nash27,
During routine sterilization what is usually being tested is LAL and BI.
From my experience what you get from the sterilization sub-contractor includes checklists, QC Form, QC report, chamber parameters with test results, and images of package and box labels.

Hope it helps.

Shimon
Hi Shimonv, Doug

Thanks for your reply. I agree with your suggestions, unlike gamma irradiation (which we are more familier with) ETO process relies on yearly validations. Would the bio-burden count have any weight for routine monitoring.

ISO 11135 section 10 Routine Monitoring and Control list the points that can be monitored by the contract manufacturer, however being product manufacturer, regulator may want to see the controls that are applied by us. I hope that bio-burden, BI results, LAL test and ETO residuals may be sufficient to monitor the routine sterilisation trend.
 
Thread starter Similar threads Forum Replies Date
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
I Certification in Sterilization for ISO 11135 and ISO 11137 Professional Certifications and Degrees 3
planB ISO 11135:2014 cancels and replaces ISO 11135-1:2007 and ISO/TS 11135-2:2008 Other Medical Device Related Standards 15
S ETO ISO 11135-1 & ISO 17665-2 - Purity and Quality of Steam (Humidity) Qualification and Validation (including 21 CFR Part 11) 3
Q Sterilisation ISO 11135 EtO-in-a-Bag (Novel Non-Traditional EtO Sterilization) Other Medical Device Related Standards 10
F Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization Other Medical Device Related Standards 4
I ETO Sterilizer Validation (ISO 11135:2007) Other Medical Device Related Standards 23
C Auditing Checklist for ISO 11135 and ISO 11137 (regulations for sterilization) Other Medical Device Related Standards 9
K EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation Qualification and Validation (including 21 CFR Part 11) 5
B ISO 11135:2007 (EtO Sterilization) ISO 13485:2016 - Medical Device Quality Management Systems 5
G EtO Sterilization - DIN/EN 550 - ISO 11135 Other US Medical Device Regulations 20
I The Status of EN 550 and Whether it will be Replaced Soon by ISO 11135 ISO 13485:2016 - Medical Device Quality Management Systems 5
K Iso 11135:1994 - Validation and Control of Ethylene Oxide Sterilization ISO 13485:2016 - Medical Device Quality Management Systems 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 12
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 2
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 0
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
Z Auditor Findings ISO 14001:2015 vs. 45001:2015 ISO 14001:2015 Specific Discussions 5
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
G ISO 17023 2017-11 - Suggestions for good books ISO 17025 related Discussions 0
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 2
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
J ISO 9001:2015, ISO 14001 & OHSAS18000 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Qualification question - ISO 13485 Reliability Analysis - Predictions, Testing and Standards 0
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
G National Structural Steel Specification 7th Edition - Do I now have to be audited against ISO 3843-3 as well as ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 8536-4 Contamination Index ISO 13485:2016 - Medical Device Quality Management Systems 0
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6

Similar threads

Top Bottom