4 Strict Requirements That Goes Into Medical Packaging

Packaging can oftentimes be an after-thought when developing products, with the actual product taking center stage. But as customers continue to demand a satisfying unboxing experience, more and more companies are starting to pay more attention to their packaging. 

This shift towards focusing more on packaging is especially important when it comes to medical packaging. This packaging does not only round off the presentation but more importantly, it keeps packages, safe, and sterile. Understanding the requirements for packaging in the medical industry is key in order to keep everyone safe.

Medical Packaging Requirements For Terminally Sterilized Devices

ISO 11607 is the standard for terminally sterilized medical devices when it comes to packaging. This standard ensures that all products are delivered safely and their integrity has not been compromised during their distribution. Therefore it is critical distributors work closely with manufacturers to make sure the selected package is able to not only reach its destination intact but also able to withstand long periods of time not being used without breaking down.

Testing the products is the longest part of the process, this can take anywhere from one to six months. During this time many tests are performed to analyze many facets of the product packaging.

Stability Test

During this test, the product endures two particular tests, examining the product’s integrity over time: which are:

  • Accelerated Aging
  • Real-Time Aging (Required to be used as a back up to Accelerated Aging)

Performance Test

Here, the product is placed under a simulation to prove the packaging can provide enough protection to the product through handling, distribution, storage, and any other hazards. This testing reviews:

  • Compressive resistance of shipping containers, components, and unit loads
  • Compressive properties of rigid plastics
  • Compressive properties of rigid cellular plastics
  • Performance testing of shipping containers and systems

Package Strength Test

The packaging’s strength is tested to ensure the sterile barrier system can preserve the product’s integrity, which includes:

  • Peel Adhesion Test
  • Seal Peel Test
  • Burst Testing
  • Burst Testing of flexible package seals using internal air pressurization 

Package Integrity Test

A number of tests to demonstrate the package’s integrity and sterility:

  • Package Integrity (Bubble Test)
  • Seal Integrity (Visual Inspection & Dye Test)
  • Seal Strength (Peel Test & Bust Test)

Pioneer Can Handle Your Medical Packaging

Packaging in the medical industry is more important than any other industry, as picking the wrong design or materials can set you back months in development and loss of money in the process. Pioneer Packaging has been engineering innovative packaging solutions for more than 35 years, meeting the stringent requirements and standards set forth by the medical industry. Contact us today to get started.

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