Effect of double ETO (Ethylene Oxide) Sterilization

medwise

Involved In Discussions
#1
Dear All,

We are doing a half-cycle validation of ethylene oxide sterilization. Our worst case device is made up of Makrolon (kind of plastic) and PVC tubing. This is a single use device and the areation period for acceptable EO residual is 20 days.

We are making 10 pallets for validation. Since this is a half cycle we wont be able to release it for sale. If we resterilise this product again after 20days can we sale this product or this 10 pallet is just a waste.

I understand that there would be some affect of EO gas if we resterilise it. Can anyone suggest me any studies or test method to determine the effect of resterilisation on the device? Is there any standard regarding this?

Any suggestions or advise will be much appreciated.

Thanks

Kindest Regards:)
Romit Singh
 
Last edited by a moderator:
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Effect of double ETO Sterilization

Can anyone suggest me any studies or test method to determine the effect of resterilisation on the device? Is there any standard regarding this?
The standard is the same as applies to all other EtO sterilization issues, i.e. ISO 11135-1. If you want to be able to sterilize product twice when necessary, you need to encompass 2x sterilization within your validation process, including ISO 10993-7 residuals evaluation.

Once a 2x sterilization validation is achieved, future half cycle study product can be salvaged by re-sterilization. That however won't do you any good for the current process.

It's common to utilize accumulated scrap product, product process-setup output, physically similar but obsolete models, etc., to make up the bulk of a challenge load of this kind, so as to minimize the economic issues involved. Only the devices to be actually lab tested for verification must be actual current product. We keep challenge load stock in our warehouse for repeated use in re-validations.
 

chris1price

Trusted Information Resource
#3
Hi

The main test after 2x exposure is going to be the effect on the EtO residuals and subsequent aeration time. If this is ok after 2x cycles, and the product is ok, then you should be able to argue that product exposed to just 1.5x cycles is ok as well.

Chris
 
M

MIREGMGR

#4
The main test after 2x exposure is going to be the effect on the EtO residuals and subsequent aeration time. If this is ok after 2x cycles, and the product is ok, then you should be able to argue that product exposed to just 1.5x cycles is ok as well.
Product functionality validation/verification and sterile barrier packaging validation, both requiring accelerated aging backed up by real time aging, are parts of the sterilization validation process. Those can be significant issues in 2x validation, in addition to residuals.

I thought the implication was that a 2x validation did not yet exist for the product in question. I would agree that a 1.5x exposure would be supported by a 2x validation, but of course it wouldn't be supported by a 1x validation.
 

medwise

Involved In Discussions
#6
Re: Effect of double ETO Sterilization

Hi MIREGMGR,

I appreciate your immediate response.

Does this mean we have to do a full validation again in order to prove that we can resterilise our product from half-cycle?

Can you please explain what do you mean by 2x?

We did our full validation in 2007 and since then nothing has been altered. And we do our requalification anually. In full validation we did 3 half-cycle and a full cycle. Does 2x means that in the full validation we should do 6 half-cycle and 2 full cycle? I am confused.

Is there any other way out to use the product from half-cycle by doing any test? Having said that what if we wait for our product till the normal aeration time i.e.20 days and send it back for full sterilisation.

Thanks for your help.

Kindest Regards
Romit Singh
 

Doug Tropf

Quite Involved in Discussions
#8
20 days of aeration seems exorbitant. We sterilize a variety of devices (kits mostly) and our longest aeration cycle is 72 hours.
 
M

MIREGMGR

#9
Very extended aeration times aren't that uncommon in EtO sterilization of long tubing sets, particularly when the polymers in question have some degree of surface absorption of EtO but aren't fully EtO permeable so that molecular presence can escape through the bulk material to the outside. Tubing sets have very slow permeation through the free ends, no matter how many air changes/hour you run the aeration chamber at.

As Harry pointed out, "2x" means "twice" or "two times". Sorry to use slang.

The sterilization validation process involves not just establishing that you are achieving sterilization, but also that your sterile barrier packaging is correctly permeable without leaks or weaknesses, residuals are acceptable at time of release for shipping, and your product and packaging aren't degraded by the sterilization process either immediately or at the end of your claimed sterility period. (There are other elements of validation of your packaging, of course, but they're off topic for this thread.) Validating for "2x" means only that after the product is sterilized twice, it still passes all of the evaluations in addition to sterility.
 

chris1price

Trusted Information Resource
#10
Hi

By 2x I mean running the same product through 2 full EtO cycles back to back. You would then check the product and packaging is acceptable and at the same time test for residuals to establish a double cycle aeration time.

This is common practice when using EtO to allow you to re-sterile product in case there is a sensor failure or other problem with the first cycle.

20 days aeration does sound long, but tubing can be difficult to fully sterilise and aerate.

Chris
 
Thread starter Similar threads Forum Replies Date
L ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022 Other Medical Device Regulations World-Wide 0
Stoic Details of Operational Qualification (OQ) test design for plastic extrusion processes, effect of material property noise, and GHTF/SG3/N99-10 US Medical Device Regulations 2
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
Q Autoclave and Sample Container - Pressure-steam cooking's effect Reliability Analysis - Predictions, Testing and Standards 1
J EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances EU Medical Device Regulations 2
C Design for Assembly in DFMEA - Failure Effect of Sub-System(s) FMEA and Control Plans 5
supadrai Effect of a Merger on Acquired Company's Medical Device Licenses Other Medical Device Regulations World-Wide 2
H New FAQ & SI -IATF 16949 - Effect in april and june 2018 IATF 16949 - Automotive Quality Systems Standard 0
G Effect of ISO9001 2015 transition on ISO IEC 80079-34 Other ISO and International Standards and European Regulations 3
N PFMEA no effect ratings FMEA and Control Plans 15
Ron Rompen The Effect of Heat on Production and Quality Human Factors and Ergonomics in Engineering 14
Q Risk Tools in ISO 31010 - Root Cause Analysis vs. Cause-and-effect Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Determining Effect of Failure without a DFMEA (Design FMEA) FMEA and Control Plans 1
D Is it okay to CE mark the product until the RoHS2 directive goes into effect? CE Marking (Conformité Européene) / CB Scheme 7
N Reason for determining no adverse effect on reworked product ISO 13485:2016 - Medical Device Quality Management Systems 8
S Seeking Feedback on ASQ Guide to Failure Mode and Effect Analysis FMEA and Control Plans 2
D Effect of Fixtures on Test Method Validation Design and Development of Products and Processes 1
P Cyclic Effect Factoring in DOE (Design of Experiments) Quality Tools, Improvement and Analysis 1
C CFDA MD regulation_20140331 - Comes into effect June 01, 2014 China Medical Device Regulations 33
M Effect of Boil Test on Passivated SS Medical Instruments Manufacturing and Related Processes 11
F Power supply certification and its effect on testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Does the SIC have an effect on the ISO scope on your certificate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Severity of Effect on Process (Manufacturing/Assembly Effect) Scrap or Reworking FMEA and Control Plans 3
M BS EN ISO 15223-1:2012 replaces EN 980 - What is the effect of the change? Quality Manager and Management Related Issues 44
C Cause and Effect Matrix Template Document Control Systems, Procedures, Forms and Templates 0
B Changes that could effect the Quality Management System - Management Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Length Out of Specification - How do I perform Cause and Effect Diagram? Nonconformance and Corrective Action 6
A Comparing Effect of Process Parameters on Equipment Performance during Start Ups Statistical Analysis Tools, Techniques and SPC 3
P Control of "manufacturing material" that has adverse effect on the medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Effect of Soldering on Tin Plating Manufacturing and Related Processes 5
D Effect of Puncture Orientation on Force Value Other Medical Device Related Standards 1
P Process FMEA with the effect "brakes are broken" - Is it nonconformity? IATF 16949 - Automotive Quality Systems Standard 7
S Root Cause Analysis & Cause and Effect Diagram Customer Complaints 5
V What effect has Supply Voltage on product performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A Main Effect - Interaction Plots - 2 Level Factorial DOE with 18 Runs Using Minitab Software 8
V Effect of sample size on Cpk results? Using Minitab Software 2
Chennaiite FMEA Severity Rating for Potential Manufacturing Effect mentioned in the FMEA manual FMEA and Control Plans 9
A Cause and Effect Analysis - Hardness of Rubber (i.e., durometer) Quality Tools, Improvement and Analysis 11
Ajit Basrur Pre Filled Syringes (PFS) - Effect of Containers on the Contents 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R EMP (Evaluating the Measurement Process) Studies for Bias Effect Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
I Quantifying the Effect of Excessive Within-Part Variation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
B Sampling Plan - AQL effect on Sample Size AQL - Acceptable Quality Level 9
S The Effect of implementation of an Integrated Management System & EFQM ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Cause and Effect Worksheet Quality Tools, Improvement and Analysis 2
M Effect of your Quality Role on your life Coffee Break and Water Cooler Discussions 31
N Uncertainty for Humidity Probes - Temperature Effect from 0.5?C dew point = 1.3%rh Measurement Uncertainty (MU) 2
A Effect of %GRR (% Gage R&R) on Cpk Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 13
C Evaluation of Bearing (Effect) of a Deviation on Quality Nonconformance and Corrective Action 10
M Pygmalion Effect - Communication The Reading Room 11

Similar threads

Top Bottom