Quarterly Dose Audit

[SMJaliparthi]

How do you perform dose audits for products manufactured at different suppliers? i.e., casted, polished and packaged at different suppliers.
We have products manufactured at different suppliers but final cleaned, packaged and sterilized at the same vendor.

 

[Jen Kirley]

Hello SMJaliparthi,

Supplier audits are done against the processes they are contracted to provide. If final cleaning and sterilization takes place at final, then casting/polishing suppliers would not realistically be audited against dosing (I take it you are referring to Gamma sterilization) unless you require them to be dosing. I would, however expect that their cleanliness requirements to be more like free of dirt, grease etc. and packaged in a manner already approved by your organization.

What is your requirement of them? Have cleanliness and packaging requirements been established for the parts?

 

[somashekar]

How do you perform dose audits for products manufactured at different suppliers? i.e., casted, polished and packaged at different suppliers.
We have products manufactured at different suppliers but final cleaned, packaged and sterilized at the same vendor.

I understand that the minimum cleanliness requirements at the various suppliers is determined and the process validated based on the final product sterilization validation. One approach is to carefully monitor the cleanliness process validation at the suppliers and identify changes made if any and how the revalidation was done and was ensured that the changes did not alter the challenge posed in the final product sterilization. An added way is to ensure that you have established good change control agreements with the different suppliers and the same are periodically renewed and come within your dose audit scope.

 

[SMJaliparthi]

Hello SMJaliparthi,

Supplier audits are done against the processes they are contracted to provide. If final cleaning and sterilization takes place at final, then casting/polishing suppliers would not realistically be audited against dosing (I take it you are referring to Gamma sterilization) unless you require them to be dosing. I would, however expect that their cleanliness requirements to be more like free of dirt, grease etc. and packaged in a manner already approved by your organization.

What is your requirement of them? Have cleanliness and packaging requirements been established for the parts?

Thank you .
Yes, Gamma sterilization. The cleanliness requirements have been established. The problem is identifying a product type / simulated product to conduct dose audit as these are manufactured at different sites. Can I have a simulated unit ( coupon ) made at one of these facilities and perform the dose audit ?

 

[somashekar]

Thank you .
Yes, Gamma sterilization. The cleanliness requirements have been established. The problem is identifying a product type / simulated product to conduct dose audit as these are manufactured at different sites. Can I have a simulated unit ( coupon ) made at one of these facilities and perform the dose audit ?

This is where your traceability requirement comes into effect. Yes, you can have simulated unit linked with the various manufacturers, perhaps even a shape defined scientifically for a particular manufacturer, and you have these supplied along with the identified batch, for the quarterly dose audit. You have to establish the process and trend the result over time to build the confidence levels.
Additionally THIS could be helpful to you.....

 

[chris1price]

I don't see anything within ISO11137 that allows the use of simulated units for dose audits. The purpose behind the quarterly dose audit is to ensure the continued validity of the sterilization dose and to identify any change in the level and resistance of bioburden. If you have different manufacturing processes then the bioburden may differ, so your rationale for the product families should be carefully considered.