Revalidation of Medical Device Packaging

by Todd McDonald on October 12, 2011

Pay attention….Make good choices…Work well with others….Don’t be lazy, but don’t show off….Be appropriate….Finish your work….

Sounds like a set of classroom rules from an elementary school, doesn’t it? But it’s actually words to live by derived from Jennifer Neid’s technical paper, “Revalidation of Medical Device Packaging: Tools for the Trade.”

As you can see below, while this paper was written just shy of a decade ago, it still provides excellent advice regarding the revalidation of medical device packaging systems.

1)   Pay Attention
Clearly, the first step in determining whether or not revalidation needs to be performed is to identify that something has changed (or will be changing) from the original packaging system (such as new equipment, product specifications, components, materials or processes). Neid’s advice: Have a testing system in place capable of yielding specific results and measuring characteristics that may vary.

2)   Make Good Choices
Next, one must determine effect of the identified change. If it affects the ability of the package to maintain sterility, safety or efficacy, Neid advises “action must be taken. ”

3)   Work Well With Others
Of course it is also essential to identify the source of the change. To do so, Neid suggests consulting others for help (from operators to suppliers to peers that use a similar process).

4)   Don’t Be Lazy, But Don’t Show Off
Of course, it’s important to keep in mind that one change may not require your entire packaging system to be revalidated. (Neid suggests using ISO 11607 as a checklist to help determine the affect of a change.) And remember, as Neid states, “In revalidation, you generally don’t want to do more than makes sense (as this takes resources you may not have), yet you don’t want to do too little, either (as you may not capture the extent of the effects of the change).”

5)   Be Appropriate
The next step is to ensure that your plan is appropriate. Neid suggests utilizing peer reviews involving engineering and production personnel, design team members, as well as those in purchasing and marketing.

6)   Finish Your Work
Naturally, the final step is to complete your documented revalidation and, as Neid reminds us, “don’t forget your final report!”

Do you think Neid’s advice still holds true? How does it compare to your revalidation process?

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