What Med Device companies look for in a Packaging PQ?
Speaking from experience of working with Medical Device companies, there are some key points to note when it comes to Packaging Validations. Any Process validation be it cleaning or packaging examines the repeatability and consistency of the process, taking into account normal variation. This “process stability” can depend on several factors that influence the performance and quality of packaging. To take a Simple Blister packaging machine. The following factors should be challenged in a Packaging Performance Qualification.
Setup – If multiple tooling is available, setup should be challenged by a tool change, at a minimum of 3 distinct setups. Remember, that Standardised setups, appropriately trained people and documented procedures should be in place.
Worker-At a minimum, two workers/operators should be used during the qualification, this takes into account normal variation from operator to operator. For example, there might be subtle differences in how components are placed.
Material- Three distinct lots for each component should be used during the execution of the Packaging PQ. This takes into account potential lot to lot differences of the material eg. Thickness.
Time- The validation should be conducted over a suitable period of time to take into account normal variation. E.g. start, middle and end of shift.
It is important to point out that PQ studies should be executed at nominal settings. Typically, 3 consecutive lots are produced.
And there you have it! By reviewing the influencing/ dominating factors of a process, a validation can be suitably designed to ensure an appropriate level of challenge is achieved.
Looking for more content, check out this pod-cast by the BBC, In-business Program on the subject "Packaging in a Pickle"
Modern living generates ever increasing amounts of packaging to wrap up the things we purchase and that generates widespread criticism of the packaging industry. But packaging companies are trying to innovate to respond to both environmental and marketing needs. Peter Day investigates what is wrapped around the products we all buy.
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