Pharmaceutical or medical device packaging plays an essential role in protecting and ensuring safety both for the product that they contain and for the end customer. For this reason, before distributing these products, it is paramount to perform a medical package testing, with the purpose of certifying their protective ability against the hazards faced during the distribution cycle.

This being the case, having a deep knowledge of the package testing standards, the distribution cycle that the product will be subjected to, and of the product + packaging system itself, is essential when developing packages for medical and pharmaceutical devices, kits and other products that require sterilization.

Accordingly, the medical packaging testing process must take the characteristics of medical packaging into account:

  • The ability to maintain the goods sterile and free from contact with the exterior.
  • An effective sealing system as well as ease of opening for the end-user.
  • Use a safety guarantee for the end customer.
  • Safety guarantee for the personnel that transports and delivers the goods.

 

Medical package testing: why it should be performed and its benefits

The purpose of medical device package testing is to thoroughly examine the package in search of possible weaknesses that might endanger the product within.

This guarantees a safe use for the end customer as well as the personnel in charge of transporting and delivering the goods, since certain medical or pharmaceutical products could be considered to be dangerous goods.

There are two main reasons why you may want to perform a medical packaging testing process:

  • To characterize the materials. Pharmaceutical packaging must provide an effective barrier that can endure diverse physical, chemical and microbial hazards. With this in mind, the testing of pharmaceutical packaging materials calibrates the ability of packaging materials to withstand these risks and maintain the product’s sterility when facing a potential external contamination.
  • To measure the sealing strength. Medical device packaging validation may also be aimed at guaranteeing that the package’s sealing system is effective against the various threats that it will encounter throughout its service life. For this, the package’s design must be intuitive so as to facilitate its opening by the end user, guaranteeing at the same time that the sealing strength will act as a microbial barrier, as will the rest of the packaging materials.

When facing these threats, medical package testing offers two main advantages:

  • Improved safety. Medical package testing enables a company to foresee the risks that might endanger the product and work toward guaranteeing that it will arrive in good sterility and safety conditions to the end customer. This translates into a number of advantages. First, the company puts measures in place to prevent damages during transportation. Second, it will be able to provide reliable information to the consumer regarding the optimal storage conditions, and will provide him with detailed information about the package’s shelf life. In other words, the customer will know for how long and under which conditions the package can keep the product inside it safe. This prevents accidents when using the medical products, while generating a safe package for all those involved in the transportation of these goods.
  • Economic savings. Testing allows for the protective ability of the medical device packaging to be determined before it is mass-produced and distributed. On one hand, this prevents the manufacture or purchase of an inefficient packaging product, and on the other, it reduces unexpected costs due to shrinkage during transportation due to inadequate packaging. Furthermore, performing a medical device package testing allows the package to be optimized, avoiding unnecessary costs linked to over-packaging.

You might be interested in learning: Which medical device packaging standards are there?

 

Existing medical packaging testing methods

Based on the specific characteristics of the pharmaceutical packaging, there are 5 types of tests that allow companies to simulate the risks of the distribution cycle with the purpose of offering a safe and optimized packaging:

Transport simulation

These analyze the hazards that the package will be subject to during the distribution cycle and include various tests:

  • Impact. Impact tests measure the ability of a package to withstand incline and horizontal impacts using simulation equipment.
  • Free fall. Free fall tests simulate drops of the transported material and the resulting damages experienced by the product + packaging system through the use of Drop Testers.
  • The vibrations that take place during transportation can compromise the protective ability of the package and damage the products that arrive to the end customer. Vibration tests allow for the study of the way in which the package performs when facing these forces, through the use of vibration simulation equipment.
  • Compression. By using a compressometer, it is possible to test the package’s resistance against vertical and lateral compression forces that typically occur during shipping, handling and storage of the goods.
  • Horizontal stability. Horizontal stability testers simulate the horizontal accelerations and decelerations that can take place during road transportation, such as accelerations, sudden stops or entering a roundabout.

These tests can be performed inside environmental chambers, so that they are performed under the real-world humidity or temperature conditions that the package will face on its way to the end customer.

Tests to verify the sealing strength

They are aimed at foreseeing the protective ability of a seal in medical device packaging and allow for the design of a safe system. Several standards apply in regard to its measurement:

  • ASTM F88-09 Standard Test Method for Seal Strength of Flexible Barrier Materials
  • ASTM F1886 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection.
  • ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
  • ASTM F2054 / F2054M – 13 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates

Tests to confirm the sterility of a package

These evaluate the package’s ability to provide an effective barrier against the entry of microorganisms. Some of these medical package tests are outlined in the ISO 11607-1:2019 standard, including the bubble test and dye penetrant test.

Testing the package service life

To guarantee that the packaging materials or their seals do not wear over time.

Extreme environmental condition testing

Which provides information regarding a package’s protective ability and its durability under various temperature and humidity parameters.

Do you need to perform medical package testing? At Safe Load Testing Technologies we help companies design a safe package through our transport simulation equipment and our experience in packaging optimization. Contact us and let’s talk about how we can help you.

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