ISO 11137 - Verification dose audit for VD max method

#1
Hi All,

I need one help with respect to verification dose audit for VD max method, we are validating our gamma sterilization process, i face problem with respect to verification dose audit, my gamma subcontractor have dose range starting at 9kGy only but my bio burden is less so the verification dose according to table 9 of 11137 is 7.5kGy,
so please let me know how i should complete my verification dose audit with this type of challenge

:thanx:
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
A Quick Bump!

This looks like a fairly complex issue, but can someone help with this question?

Thank you very much!
 
B

brianthermophilus

#3
If that's your only dose option and your bioburden is lower, I would run your samples through 9kgy and perform material & packaging assessments to confirm that your product may withstand a higher dose. Nothing wrong with a higher dose as long as your product can handle it.
 
#4
If that's your only dose option and your bioburden is lower, I would run your samples through 9kgy and perform material & packaging assessments to confirm that your product may withstand a higher dose. Nothing wrong with a higher dose as long as your product can handle it.


Thanks for your comments, this is verification dose to have confidence on my sterility not material compatibility excersise


Sent from my iPhone using Tapatalk
 

pkost

Trusted Information Resource
#5
I would suspect using a higher dose will make the validation ineffective - from recollection the dose is low enough to give a an SAL of 1x10^-2....The subsequent sterilisation tests are sufficiently powered establish the SAL is validated....if you use a higher verification dose then the sterility tests will not be sufficiently powered

I think it is permitted to carry out the VDmax study at any facility, it does not have to be the main site of sterilisation - if you can find somewhere that operates at 7.5kGy, that may be a solution
 
Last edited:
#6
I think doing dose mapping with 2 different other sources will give you different uncertainty and sterilizing agent characteristics , i am not sure if standard allow me to do ths because i am not as much expert than you may be pls correct me if i am wrong, if it is ok thn my prblm is solved


Sent from my iPhone using Tapatalk
 

pkost

Trusted Information Resource
#7
From my understanding, the dose setting is to demonstrate that the the 25kGy is sufficient to give an SAL of 10-6...25kGy is the same regardless of equipment used; the sterilising agent is gamma radiation...it's consistent

Dose mapping is different as it demonstrates that the entire load receives a dose of 25kGy...I suspect that this may need to be carried out in the intended sterilising facility, but I'm not sure.

The lab that is conducting the validation for you should be able to answer these questions and provide more qualified guidance!
 
Thread starter Similar threads Forum Replies Date
F Irradiation Sterilization Validation Maximum Dose - VDmax 25 method (ISO 11137) EU Medical Device Regulations 2
R ISO 11137 Gamma sterilization validation, dose setting, dose audit Other Medical Device Related Standards 1
I Certification in Sterilization for ISO 11135 and ISO 11137 Professional Certifications and Degrees 3
S If this EN ISO 11137 certificate acceptable for Contract Sterilization? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Does anyone have a summary of changes made to ISO 11137-2? Other Medical Device Related Standards 3
F ISO 11137 - Flow Chart | Decision Tree sterilization Other Medical Device Related Standards 4
K Very small batch validation ISO 11137 (VDmax25) ISO 13485:2016 - Medical Device Quality Management Systems 6
S Controlled Environment for Manufacturing Sterile Product - ISO 11137 Other Medical Device Related Standards 2
C Auditing Checklist for ISO 11135 and ISO 11137 (regulations for sterilization) Other Medical Device Related Standards 9
M Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 11137 Other Medical Device Related Standards 8
E ISO 11137 gamma sterilized device dose audit - Lead time? Other ISO and International Standards and European Regulations 7
M Gamma Sterility Validation - ISO 11137-2, 4.2 vs. FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 11137:1995 Sterilisation of healthcare products - Amd1:2001 ISO 13485:2016 - Medical Device Quality Management Systems 5
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 8
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
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 6
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P ISO 80369 and endoscope port/lumen Other ISO and International Standards and European Regulations 4
C ISO 639-1 Languages Other Medical Device Related Standards 0
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Logistic organization and controls - IATF/ISO 9001 audit Nonconformance and Corrective Action 2
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 17021-1:2015 toolkit General Auditing Discussions 2
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11

Similar threads

Top Bottom