In designing sterile barrier systems for medical devices, key questions should be thoroughly assessed:
- What factors could compromise pack sterility: size, shape, weight, physical configuration, chemical content…?
- How many products are in a pack? How many packs will be in a production run? How many packs do I except to sell in a year?
- What sterilisation method will be used? Might the package be subjected to more than one type of sterilisation?
- What method of delivery at point of use is required? Are there factors at the point of delivery that may affect the method of delivery?
- What is the distribution channel (Local? National? Continental? Global? Environmentally controlled? Cold chain?)
All these questions will help determine not just the choice of materials but also the type of equipment required to pack on.
While smaller volume products or those devices which are delicate or hard to handle could be packed manually usually by using a table top pouch or tray sealer, equipment automation can be interesting for larger volumes.
Machines for primary packaging can be divided into 5 categories:
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