Revalidation under VDmax25 following material change

#1
Hi all

We are looking at a material change to a single component in one of our devices due to supply issues.
The gamma sterilisation process has been validated using VDmax25.
The new material is a slightly different hardness of the same material grade used in the original. The volume and surface area of the component (and device) have not changed and the difference in density between the original and proposed components is <1%.
The manufacturer, process, manufacturing environment, handling etc. will not change.

What I was wondering is whether this would/should trigger a sterilisation revalidation?

Thanks in advance.
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Have a look into ISO 11137-1, section 12.5.2, Assessment of change:

A change in product, its package or the presentation of product for sterilization shall be assessed for its effect on the appropriateness of the sterilization process. Those parts of process definition or PQ that have to be undertaken shall be determined based on the nature of the change. The outcome of the assessment, including the rationale for decisions reached, shall be recorded (see 4.1.2).
From what you write, you seem to have gathered evidence that you do not significantly change "the presentation of product". You may also want to demonstrate that your change in material has no significant impact on the bioburden of your final device, either with a rationale or e.g. by a dose audit together with a bioburden determination of your changed final device.

Hope this helps,
 

Philip B

Involved In Discussions
#3
You could also talk to your test lab, they often have their own guidelines on what changes would necessitate a new sterilisation validation.
 
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