ETO (Ethylene Oxide) Sterilization Audit Question

C

CarlyH

#1
Hi All,

We recently validated an ETO cycle using the overkill approach.

A question has come back "1/2 cycles were performed date 1, date 2, date 3. Can it be demonstrated that these were consecutive experiments?"

Which leads me to two questions: since the dates listed pretty much were consecutive dates, are they asking whether there was overlap in the studies or is there something extra that I don't comprehend maybe based on an ISO 14161?

thanks for your help!
 
Elsmar Forum Sponsor
C

CarlyH

#2
Re: ETO Audit Question

Ok, Follow-up to the question:

It appears that the half cycles were not consecutive, as there was a problem with the first one (It hung during the flush cycle) and so they repeated it after 2 full cycles.

Are we likely to have a problem with them not being consecutive?

Thanks in advance for any comments!
 

planB

Super Moderator
#3
Carly,

I guess you were audited against ISO 11135-1:2007, and not the brand-new ISO 11135:2014?

ISO 11135-1:2007, Annex B.1.2 a) it says "Half-cycle approach: a total of three consecutive experiments ... shall be performed ..."

IMHO, _consecutive_ does not imply that you have to perform these runs on the same day or back-to-back, but in a chronological order according to what you have defined in your protocol. The intention of three related runs is that you can demonstrate _reproducible_ cycle lethality.

So if you can show the auditor that you did your half-cycle runs in a reproducible way according to your protocol, it should be fine.

Regarding your follow-up question:
Do I understand you right, that you actually performed 4 half-cycles, of which the first run was not within cycle specification. But still you have three half cycles runs in a consecutive way, passing your acceptance criteria? If yes, this could still be acceptable, provided you also pass the PQ and can document an acceptable rationale (refer to section 9.3.3.1) why the observed cycle deviation is not relevant to the effectiveness of your sterilization process.

HTH,

Gerhard
 
C

CarlyH

#4
Hi Gerhend,

Thanks for the reply, I've yet to purchase the new 11135 so I hope nothing has changed, but the audit is current, so they are probably aware of it!

The contract steriliser had a problem with the first half cycle they did- the flush cycle didn't engage properly due to a "hung" system and the half cycle was more like a 3/4 cycle as the gas wasn't evacuated. This cycle was then discarded.

The kept on with the schedule ran HC2, HC3, then did FC1 and FC2 before then going back and doing HC4 which they conveniently called HC1 in the report!

The repeatability of the sterilisation is shown,- if not the reliability of the actual systems they use!

I will say something similar, about the repeat ability of the sterilisation being the key question here.

I am currently trying to work out whether they used an exhaustive extraction method or simply a Simulated extraction method because the report does not really give me enough information to go on!
 

planB

Super Moderator
#5
ad (1) Refer to ISO 11135:2014, table C.2 for the minimum number of required humidity sensors

ad (2) The easiest way to fulfill, ISO 11135:2014, section D.9.3.2 b)(3) is to record the temperature range in your empty chamber during EO dwell time.

Copies of TIR16 and TI28 are available from AAMI's store.
 
#6
Does ISO 11135:2014, section D.9.3.2 b)(3) have to be fulfilled in order to be in compliance or is it a suggested target? I'm missing the criteria by less than 1 degree but the PQ is passing. Why does it matter if there is a slightly larger difference in temp averages near the door? And where did +/- 3 degrees Celsius come from? Thanks!
 

planB

Super Moderator
#7
Randall,

the section, you are referring to, is part of an informative annex - quote:

The guidance given in this annex is not intended as a checklist for assessing compliance.[...] Methods other than those given in the guidance can be used, providing their performance achieves compliance [...].
The intention of this section is to provide guidance on how to demonstrate an acceptable temperature profile throughout the usable chamber volume: potential "cold spots" in the chamber may lead to a reduced cycle performance in these locations. Did your PQ cover these spots (I assume that you are talking about lower limit temperature excursions), e.g. by having placed PCDs there (during MPQ) and residuals samples (during PPQ)? If yes, then you would have a rationale why deviating from the recommended temperature band is still acceptable in your case.

Other topics you might is explore are
- the actual measurement itself: does that <1 K deviation relate to an actual measurement or might that reading be attributed to the measurement uncertainty of your temperature probes?
- design of your water jacket: Is the deviation plausible, i.e. would you expect a cold spot near the doors, e.g. because your doors are not heated the same way as the chamber walls?

To my knowledge, the +/- 3 K are an empirical temperature band.

HTH,
 
#8
Hi planB,
Thanks so much for addressing my issue. I think everything you said is rational and makes sense. I feel the same way, and it is nice to have someone to confirm.
 
#9
Hi Plan B,

I'd like to ask you another question. I can start a new thread if needed.

An auditor asked me if we use BS_EN_285 guidelines for our steam purity. I said no. We use 100% EO and not pure steam which is what 285 outlines. We have internal standards for allowable amounts of iron and chloride in the feed water and pH of the feed water. Our internal standards are considerably more relaxed than what is given in 285.

No one has told us we need to meet 285, but we are working on a rational for not following 285. My company has never gotten a complaint saying a patient was put at risk by steam contaminants on a device. Also, the materials we use to make our products can not be harmed by low levels of any contaminate that may be in steam.

Do you have any additional suggestions for this rational? (or do you think we should be following 285?) Thanks!
 

planB

Super Moderator
#10
Randall,

the governing standard is ISO 11135:2014, which is rather silent about the feed-water quality except some vague guidance in section D.6.3.2 d) "Steam is utilized to humidify the load and is not intended to be a sterilant. The consistency of steam supply can be determined by the periodic analysis of the boiler feed water or condensate."

I am suspecting that the auditor has EN 285 in mind because only there, specific contamination limits are proposed in informative Annex B therein. You are free to consider these limits as reference for your feed-water quality, but you absolutely do not have to. As long as your feed-water specification can be demonstrated to be adequate to not adversely affect product getting in contact with humidity generated from this feed water, you are all settled.

Hope this helps,
 
Thread starter Similar threads Forum Replies Date
N Decision to file a new 510(k) - ETO (Ethylene Oxide) Sterilization Other US Medical Device Regulations 4
M Effect of double ETO (Ethylene Oxide) Sterilization ISO 13485:2016 - Medical Device Quality Management Systems 13
K EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation Qualification and Validation (including 21 CFR Part 11) 5
V EMS for Medical Device Facility with Ethylene Oxide (ETO) Sterilization process. Miscellaneous Environmental Standards and EMS Related Discussions 4
chris1price EtO Sterilisation Consultant Wanted Job Openings, Consulting and Employment Opportunities 0
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
A Is Aeration Process in ETO Sterilization Validation Required? Manufacturing and Related Processes 7
N ETO Sterilisation Validation - EO Residual Minimum Sample Requirement ISO 13485:2016 - Medical Device Quality Management Systems 2
N Converting ETO Residual Limits from PPM to mg ISO 13485:2016 - Medical Device Quality Management Systems 6
N ISO 11135 Monitoring Routine ETO Sterilisation Parameters Other Medical Device Related Standards 3
M Is it essential to do the Fractional Test for ETO Revalidation? ISO 13485:2016 - Medical Device Quality Management Systems 1
K Re-validation of EtO sterilization after change of tape Other Medical Device and Orthopedic Related Topics 1
A How to overcome brown stains after ETO sterilization process ? Other Medical Device Related Standards 2
B Number of Biological Indicators for Routine Monitoring of ETO Sterilization Cycle Other Medical Device Regulations World-Wide 8
S Fractional cycle fail in Eto sterilization validation ISO 13485:2016 - Medical Device Quality Management Systems 3
R Eto Sterilization Product Adoption SOP ISO 13485:2016 - Medical Device Quality Management Systems 4
M EtO compatible or recommended materials Other Medical Device Regulations World-Wide 1
X EtO Steriliser Software (PACS) Update Validation Requirements Qualification and Validation (including 21 CFR Part 11) 5
S IV Catheter Biological Evaluation - EtO Residuals - Permanent Contact Definition Qualification and Validation (including 21 CFR Part 11) 2
S ETO ISO 11135-1 & ISO 17665-2 - Purity and Quality of Steam (Humidity) Qualification and Validation (including 21 CFR Part 11) 3
A Eto Sterilisation Re-Validation Requirements Other Medical Device Related Standards 4
Q Sterilisation ISO 11135 EtO-in-a-Bag (Novel Non-Traditional EtO Sterilization) Other Medical Device Related Standards 12
A Aeration Room Requirements for EtO Sterilization Other US Medical Device Regulations 3
T ETO Sterilization through luer caps Manufacturing and Related Processes 5
F Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization Other Medical Device Related Standards 4
N EtO Sterilization Process Waste Treatment System Other Medical Device Related Standards 1
G "Intrinsically Safe" requirement - EtO sterilization of device with Battery Other Medical Device Related Standards 9
D Will just Heat and Humidity be Adequate to Simulate EtO Sterilization? Design and Development of Products and Processes 2
K Sterilization for Hypodermic Needle - EtO or Gamma? ISO 13485:2016 - Medical Device Quality Management Systems 1
D ETO Sterility Requirements for FIM Clinical Study in Europe Other Medical Device Regulations World-Wide 3
Mikilk ETO Sterilization - Annual Report of all Sterilization Validations to send the NB EU Medical Device Regulations 3
L ETO vs. Gamma Irradiation Sterilization of DBM (Demineralized Bone Matrix) Other Medical Device and Orthopedic Related Topics 3
S AAMI TIR28:2009 Product adoption & process equivalency for ETO sterilization Other US Medical Device Regulations 2
P ETO Sterilisation of Single Use Part supplied in Non-Sterile State EU Medical Device Regulations 12
I ETO Sterilizer Validation (ISO 11135:2007) Other Medical Device Related Standards 23
M Eto Certificate of Sterilization (vs. gamma irradiation) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B ISO 11135:2007 (EtO Sterilization) ISO 13485:2016 - Medical Device Quality Management Systems 5
I Guidelines that specify the frequency of ETO Sterilizer Re-Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
T ETO Sterilization - Process monitoring and out-inspection ISO 13485:2016 - Medical Device Quality Management Systems 3
M Japanese rule on EtO residuals in sterilized medical devices? Various Other Specifications, Standards, and related Requirements 16
G EtO Sterilization - DIN/EN 550 - ISO 11135 Other US Medical Device Regulations 20
Ajit Basrur Audit Checklist for Contract Gamma and ETO Sterilization needed ISO 13485:2016 - Medical Device Quality Management Systems 3
T ETO Product Sterilisation Testing Standard Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
V ETO Sterilization of Urological Catheter ISO 13485:2016 - Medical Device Quality Management Systems 5
Q EtO vs. Gamma Sterilization - Stainless Steel and Titanium Orthopaedic Implants ISO 13485:2016 - Medical Device Quality Management Systems 7
C How to verify the SAL (sterilie acceptable level) is 10-6 for ETO Sterilization ISO 13485:2016 - Medical Device Quality Management Systems 6
G Supplier audit of ETO Sterilization Lab - Need a checklist or advice Supplier Quality Assurance and other Supplier Issues 3
P ETO Sterilization Validation Process and an NCR - ISO 13485:2003 CMDCAS audit ISO 13485:2016 - Medical Device Quality Management Systems 1
M Informational USFDA Ethylene Oxide Sterilization for Medical Devices website Medical Device and FDA Regulations and Standards News 0
M Informational FDA Posts Information about Ethylene Oxide Sterilization and Medical Devices Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom