Medical Primary Packaging: Importance and Benefits
Learn about medical primary packaging and its role in protecting products with proper design and material choices.
Primary packaging is the first level of medical product packaging — the sterile barrier system in direct contact with the device. The right combination of pouch style and material protects sterility through processing, shipping, and shelf life, and presents aseptically at the point of use. The best way to choose a style and features is to work with an experienced packaging engineer; a poor fit between product and packaging often causes damage whose cost exceeds any savings from off-the-shelf packaging.
Pouch Styles
Common medical-device pouch constructions and where each fits best.
Chevron Peel Pouch
Most commonly used for sterile medical products that don’t require the rigidity or other protective characteristics of a thermoformed tray. The most popular materials used in this pouch construction are a Tyvek back and a clear film face.
Corner Peel Pouch
Same construction as a chevron pouch with a different seal configuration. Corner peel pouches are used when it is desirable for the product to fit close to the top seal of the pouch, or for bulky products.
Squared Sealed (No-Peel, Tear) Pouch
Commonly used for multi-layer laminate barrier materials. The heat seal is permanent and cannot be peeled apart; a tear notch is typically provided in the heat seal near the top of the pouch to facilitate opening.
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Header Pouch
Two layers of clear thermoplastic film form the pouch and a strip of breathable material (usually Tyvek) is sealed along the topside. The strip is peeled off to access the contents. Clear construction allows the product to be seen from both sides. Most commonly used for bulky items and large items such as procedure kits.
Standard Method of Dimensioning Pouches
- All pouches, regardless of style, are defined by their outside dimensions.
- The “A” dimension is the opening or width and is always listed first.
- The “B” dimension is the length and is always listed second.
- Example: 4″ x 8″. The 4″ dimension is the width and the 8″ dimension is the length of the pouch.
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