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MedTech Outlook | Thursday, May 27, 2021
The primary purpose of sterile packaging is to ensure sterility from the manufacturing line to the surgery center.
FREMONT, CA: Maintaining a medical device's sterility is essential for protecting patients and preventing disease transmission during surgery. In the medical device industry, achieving and sustaining sterility are two of the most challenging tasks. Packaging plays a vital role in helping medical device manufacturers achieve and maintain sterility. The primary purpose of sterile packaging is to ensure sterility from the manufacturing line to the surgery center. Packaging is subjected to testing and validation to ensure that it can preserve its sterilization integrity before it is used.
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In medical devices, there are many different types of sterile packaging. Trays (metal or plastic) and pouches (paper/plastics) are the most popular sterilization packets used in medical devices.
Thermoformed Trays
Thermoformed trays may be made of plastic or metal. Thermoformed trays are made specifically for each use. Thermoformed trays are a low-cost, long-lasting packaging solution that provides a sterile barrier. Tyvek lipstock is used to seal thermoformed trays. Tyvek is a one-hundred percent synthetic material made from spun-bound polyethylene fibers with a high density. It is light, solid, and breathable, but it is also water, abrasion, bacterial penetration, and aging resistant.
Polyethylene or Polyamide Film Pouches
Polyethylene or polyamide film pouches are used for packaging devices that need to be protected from sun, moisture, or oxygen. Moisture and gas barriers are strong in polyethylene and polyamide films. Gas sterilization of polyethylene or polyamide film pouches requires the use of a Tyvek or medical paper strip inserted in the pouch to allow the gas to move through and sterilize the medical device. Otherwise, the gas would not be able to penetrate the film if it is contained in polyethylene or polyamide film pouches.
Metal Trays
Metal trays are commonly used to store medical instruments or screws. Aluminum or stainless steel is used to make metal trays. Metal trays can be customized to meet the specific needs of the products. They can include polymer inserts for lightweight, long-lasting device safety. They also allow for the simultaneous organization, delivery, and sterilization of multiple devices. During sterilization, trays are covered in a flat wrap to preserve sterility after the cycle is completed.
Aluminum Foil Pouches
Aluminum foil-based pouches are used for photosensitive packaging devices or require a high level of moisture resistance. Heat seal, simple lint-free peel, and protection from sharp edges of the packed device are all provided by combining Aluminum Foil with Polyamide or Polyethylene based films. The pouches made of aluminum foil are sterilized by exposing them to radiation.
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