Sterile Packaging Assessment to Determine Your Level of Risk
Have you ever attempted to assess your level of risk for a sterile medical device package and its manufacturing process? Some may call this a state of compliance, but if specific items are not met or are incomplete, there is risk involved.
In an attempt to provide some meaningful and useful tools to determine your level of risk associated with package and process validation, I dug into my archives and came up with this checklist. It is simply a tool to aid in understanding where you or your company stand with regard to package and process validation.
There is an attempt to provide validity to each item with CEN/ISO 11607 Part 1 and 2, or the US Food and Drug Administration's Quality Systems Requirements. However, there are items that are not part of either organization's requirement. These items simply make good sense and are included to ensure a quality package is produced.
In the Process Validation section, you will find the terms "equipment qualification" and "process qualification" instead of the current terminology "installation, operational and performance qualifications." I agree that these may be outdated terms and do not conform to present terminology, but the individual requirements are still valid.
If you can say "yes" to all items, you will certainly be producing a robust (and validated) sterile medical device package.
Hal Miller, President, PACE Solutions