How Medical Device Packaging Protects Life-Saving Devices

Posted by Rob Helmke | Tuesday, November 22, 2016 1 Comment

Although the pharmaceutical and medical device packaging industry is varied and complex, it’s dominated by three main types of packaging:

  • Medical work-in-progress (WIP) trays
  • Pharmaceutical packing for prescription and over-the-counter (OTC) distribution
  • Sterile barrier medical device packaging

Medical TrayWIP trays allow pharmaceutical companies and medical device manufacturers to safely store and transport products en masse. Primarily used for storage or to move components from one manufacturing cell to another, WIP trays can also be used for final delivery of pharmaceuticals or medical devices such as syringe barrel trays or electrical components.

Pharmaceutical packaging, on the other hand, encompasses any type of packaging that contains an OTC pharmaceutical product or drug or drug delivery device, such as a syringe. This packaging protects the product from damage and contamination during shipping and can be designed to aid the end user in actual delivery of the drug. Pharmaceutical packaging includes pill and syringe clamshells, pill and syringe blister packs, and liquid dosage cups.

Many medical products — among them heart transplant kits, chemotherapy kits, and catheters — require specialized sterile barrier medical device packaging. This unique type of packaging protects medical devices during sterilization, shipping, and throughout use in hospitals. Many implantable products such as bone putty and diabetes drug delivery devices also require this type of packaging.

The Importance of Specifications

Pharmaceutical and medical device packaging must meet strict specifications to ensure patient safety. After specification development, medical packaging is subjected to rigorous testing procedures during which precise requirements and specifications can be tested and confirmed, or, if needed, rejected and redeveloped.

Minimum thickness is often the most important specification for pharmaceutical or medical device packaging design. Because three common sterilization processes — ethylene oxide (EtO) sterilizations, gamma sterilization, and autoclave sterilization — kill all forms of bacteria but are very harsh on plastic materials, maintaining minimum thickness is imperative to ensure that the packaging retains its sterility and physical properties. If the sterility of the packaging is compromised, the sterility of device itself is also considered jeopardized. Although most packaging has a minimum thickness of 0.005 inches to assure it can withstand sterilization and shipping, testing may sometimes show that a minimum of 0.003 inches or even 0.010 inches is acceptable.

The flatness or warp of a product is also very important. Pharmaceutical and medical device packaging is often heat sealed with Tyvek lids; if the flat seal flange is warped in any way, successful sealing can become challenging, and seals can become undone, risking contamination. Finally, cleanliness must always be taken into account, as dust or other particles can easily contaminate medical devices. Sturdy seals help to ensure cleanliness.

Many non-hospital emergency scenarios may require unique specifications. In ambulances, for instance, ease of transport should be considered. Keeping the end user in mind at all times — and ensuring adequate simulations and testing have been done to fully understand the unique needs of particular applications — is essential to ensure quick, efficient treatment of patients.

medical-package-designWhy We Invest in Medical Device Packaging R&D

Since 1972, Plastic Ingenuity has been an industry leader in custom pharmaceutical and medical device packaging. Our team’s experience includes working with clients in the medical device industry. We pride ourselves on our continual research and development to help deliver lifesaving products to patients worldwide.

Our team is devoted to more than just high-quality packaging; we understand that patients’ lives depend on safe, sterile packaging, and at Plastic Ingenuity, we take that responsibility very seriously.

To learn more about Plastic Ingenuity and how we help doctors, nurses, and patients every day, download our Medical Packaging Capabilities Sheet.

Preserve the integrity of your medical device

Topics: ETO sterilization, medical device packaging, Medical packaging, medical packaging, medical plastic packaging, Plastics