In-process Package Testing for the Manufacturing Process

摘要

For many medical device manufacturers (MDMs), it is an accomplishment to bring their packaging and sealing operations in-house. However, when you're not the expert on a certain process in the medical device packaging supply chain, bringing your sterile packaging in-house can create problems. Systems are available that MDMs can put in place to make sure their sealing and packaging process remains good over time, and one of those is in-process testing. There are three parts to in-process testing, and we'll look at each one below. Think about what is happening at your facility during the packaging process. Your operators are gowned up in the clean room, inserting your device into the packaging, and sealing it. Therefore, your in-process testing should be evaluating the sealing process. It is imperative that the sealing process remains good over time and it's important that the packages being sealed are tested in-process for each lot to make sure there aren't any weak seals going to market.