Adding an extra Label on an Ethylene Oxide Sterilized Box

dr1vn

Involved In Discussions
#1
I have a device that is packed in a cardboard box and then sterilized via EtO. The sterilization process has been validated. Does adding an extra label to the outside of the box before the device gets sterilized mean a new validation study to ensure the EtO is not absorbed by the new label? i.e. does the addition of a new label affect permeability of the EtO gas through the box?
 
Last edited:
Elsmar Forum Sponsor

bjohnsonrli

Starting to get Involved
#2
Hi dr1vn,

I would recommend reading through AAMI TIR28:2009(R)2013 Product Adoption and Process Equivalence for Ethylene Oxide Sterilization. Annex A contains a list of questions which we took and made into a type of product adoption form and use it to determine if further evaluations are required with a candidate product or to document the rationale for adopting the candidate product into the cycle.

In general, the answer to your question is, maybe...Adding a label could effect the transfer of heat, moisture, or gas. This would depend on the size of the label, the material permeability, etc. Assuming that you are using a contract sterilizer, they should be able to walk you through the process and even provide services for product adoption studies ($$$).

Assuming you are using the overkill EtO method, I would recommend performing a reduced microbial study. Otherwise, you will need a solid rationale to justify your reasons that the addition of the label does not compromise the effectiveness of the sterilization cycle.
 

planB

Trusted Information Resource
#3
dr1vn,

concurring with bjohnsonrli:

You have to evaluate whether the additional label implies that your product constitutes a greater challenge to the sterilization cycle than you validated product in terms of

- cycle lethality: can you demonstrate with existing data that your product with label does not create a more tortuous pathway for the sterilant gas (and humidity) to achieve the required SAL? Does your PCD (process challenge device) cover your product with label?
-> "Is it harder for the gas to get in?"

- residual levels: can you demonstrate with existing data that your product with label does not have a negative impact on the aeration properties of your product and thus negatively affect your validated residuals levels? Would you have another worst-case product for residuals that still covers your product with attached label?
-> "Is it harder for the gas to get out?"

As bjohnsonrli popinted out, AAMI TIR28, question list in annex A helps you through this evaluation process. In case of any "yes" answer, consider to perform (limited) experimental re-validation work.

HTH,

Gerhard
 

dr1vn

Involved In Discussions
#4
Thanks Gerhard and bjohnsonrli,

I checked the standard and I feel like I should be answering "yes" as a label on a cardboard box would impede gas going in and out... that is if the gas permeates through the cardboard to get into the device packaged within. If the gas goes around the corners and folds to reach the device then perhaps a label on the outside is okay.

Since permeability is an unknown, then I think a study is in order to at least put some numbers behind our ultimate labelling decision
 
Thread starter Similar threads Forum Replies Date
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
D Adding a Class I to a sample box Canada Medical Device Regulations 5
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 10
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
F Adding a medical device in another medical device package EU Medical Device Regulations 2
K Relabeling or Not Relabeling - Adding our internal Part Number barcode label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Adding Remote Site to Current IATF 16949 Certification IATF 16949 - Automotive Quality Systems Standard 2
S Adding Value prior to signing EASA Form 1 EASA and JAA Aviation Standards and Requirements 5
D Adding a new site to 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S Adding claims on medical device labelling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Adding a UDI Compliant Label to previously manufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
L IATF 16949: Adding a Remote Location between certifications IATF 16949 - Automotive Quality Systems Standard 2
T Adding an adapter to a Torque Meter to change the Range Capability, Accuracy and Stability - Processes, Machines, etc. 6
R Coexisting Investigational Use and CE-Mark - Adding a new Indication EU Medical Device Regulations 4
K Adding a New Site to Our ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 9
C Adding information to Labels - Class II Medical Devices US Food and Drug Administration (FDA) 1
K Medical device procedure tray - Adding products in Custom packs Other Medical Device and Orthopedic Related Topics 3
E Adding a "Scope Statement " to my Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W Quality for value adding or certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
somashekar Adding an other process into the system - Authorised Economic Operator (AEO) Scheme ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Adding 1% error to data in a column in Minitab Using Minitab Software 3
M Is 510k Required for Adding a section on use of Disinfectants to Product Manual? US Food and Drug Administration (FDA) 3
D Adding PPAP forms to the ISO procedures Document Control Systems, Procedures, Forms and Templates 2
S FDA CDRH Premarket Review Submission Cover Sheet - adding more products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B What to do when adding new Proprietary name under same 510(k) Other US Medical Device Regulations 2
M PPAP requirements when adding Part Transfer Robots between Machines APQP and PPAP 1
M Adding AS9100C Lead Auditor Certification to an IRCA ISO 9001 LA Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Need help in adding second location to FDA Registration Other US Medical Device Regulations 4
K Adding a Disclaimer on an FMEA FMEA and Control Plans 4
M Adding Bizminer's Industry Financial data to my Peer Company Comparison Manufacturing and Related Processes 0
D Rounding Numbers - Adding numbers in Excel - I want the average Excel .xls Spreadsheet Templates and Tools 3
F Implementing ISO 11135 - Facilities Conditions - Adding ETO Sterilization Other Medical Device Related Standards 4
Q Adding to our A2LA Scope of Accreditation General Measurement Device and Calibration Topics 2
AshleyE ISO 9001 company now adding Welding to the Scope - What needs to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
marmotte Adding a Funct. Earth. to a class II / BF device...retest needed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Document Changes not affecting the process - Adding Logos, etc. Document Control Systems, Procedures, Forms and Templates 8
V Option for adding date-time to the copies printed from Adobe Acrobat (pdf) Quality Assurance and Compliance Software Tools and Solutions 1
V What are the Value Adding Quality Assurance Processes and how to measure them? Quality Tools, Improvement and Analysis 3
P Can 'adding a new service' be a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Quality System Manual question - Adding Satellite Facility ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Adding Malicious Operator to FMEA? Quality Manager and Management Related Issues 12
F Adding a New Office Location to an ISO 9001 Certificate (Scope of Registration) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Adding ISO13485 to existing AS9100 QMS - Summary of the differences ISO 13485:2016 - Medical Device Quality Management Systems 9
S Adding an additional site to our current TS 16949 registration scope IATF 16949 - Automotive Quality Systems Standard 5
N Pivotal in Value adding to the Implementation of Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
E Adding value to audit using checklist & getting results ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom