While some medical device manufacturers (MDMs) have their own packaging lines and skills, many businesses outsource their medical device packaging to a contract packager. Small-batch sealers are cheap, but high-volume production necessitates costly packing equipment that takes up a lot of valuable floor space in a manufacturing plant. As a result, many businesses prefer to hire a contract packager instead of investing in expensive equipment and space.
While Medical device packages there are multiple factors that need to be taken under consideration by a contractor. Read the full article to know more about medical device contract packaging.
Following are a few of the factors that should be taken under consideration while contract packaging:
Food, consumer goods, medical equipment, and pharmaceuticals are all packaged in some way. The medical device and pharmaceutical industries are governed by a system of laws and regulations that ensure that their goods are both safe and effective, as well as sterile to the point of use when necessary. A contract packager who regularly packages food or consumer goods may not be familiar with all of the medical and pharmaceutical packaging standards and requirements.
The packing procedure must be validated. This involves, at the very least, an Installation Qualification (IQ), an Operational Qualification (OQ), and a Performance Qualification (PQ) for the equipment in question. You'll also need a process specification for the packaging's shaping, assembly, and sealing.
The packaging equipment must be calibrated and maintained by the contract packager. They should, for example, have procedures and regulations in place to guarantee that the sealer operates within the certified process parameters at all times.
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