The importance of medical device packaging should not be underestimated – the product being delivered to the consumers safe and sound depends on it. Performing the necessary tests and complying with the requirements is essential, which is why the medical packaging design should be taken into account since the very start of the product development process.
What is medical device packaging?
Medical device packaging is a term that includes all packaging conceived to address the specific needs that medical devices present in order to endure the distribution cycle and its many risks. It is thus the main barrier between medical products and the menaces that could compromise them and performs crucial tasks such as maintaining the sterility of medical devices.
The importance of medical device packaging
Lack of proper medical device packaging can lead to serious problems for companies and their customers.
Medical device packaging materials and the designed packaging system as a whole must withstand transportation and storage conditions, and arrive at their destination without any broken seals or holes. On the contrary, incorrect packaging configuration can be the source of economic losses and failed product launches.
Medical device packaging requirements
Complying with packaging requirements is the responsibility of the medical device manufacturer. This is the only way to guarantee that the products will be protected during transportation, and that they comply with health and safety regulations.
Pharmaceutical and medical products have certain special characteristics (such as their limited shelf life). For this reason, their requirements for transportation and commercialization must be aligned with them.
The protocols aimed at guaranteeing their safety focus on factors such as the seal integrity, materials or how the package reacts to the passage of time.
At a government level, the most important regulations are those of the Food & Drug Administration (FDA) in the United States, and the Medical Devices Directive in the European Union.
Medical device packaging doesn’t just need to arrive at the hospital, clinic, or end customer free from holes, tears or missing seals; it must also withstand the passage of time in storage, where it must be able to remain for years without the drug or device having their composition altered.
Some of the medical device packaging protocols include:
- ISO 11607 Packaging for terminally sterilized medical devices.
- EN 868 Packaging materials and systems for medical devices to be sterilized, General requirements and test methods.
- ASTM D1585 Guide for Integrity Testing of Porous Medical Packages.
- ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products.
- ASTM F3475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials.
- BS EN ISO 15378:2017 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP).
- ISTA 3 packaging and transport standards are now official standards to be used for FDA approval on medical devices for the US market.
- ISO 11137, which measures Gamma and E-beam sterilization.
Before performing any of these tests, one must ensure that the package is sterile, so that protocols are performed on a product that is exactly in the same condition as that of the product to be commercialized.
Testing processes for medical packaging design
> ISTA 1 Series
Integrity performance tests without simulation to test the resistance and strength of the product-packaging combination.
>ISTA 2 and 3 Series
These involve general simulation performance tests via simulation designed to mimic the conditions that may be experienced during the shipping process.
- Environmental conditions.
- Random vibration through the use of vibration equipment.
- Drop Tests from different heights.
Protocol ISO 11607 outlines the key aspects of pharma and medical device package testing.
This ISO standard for medical device packaging offers a framework for medical packaging, focusing on key processes such as sealing and other closure systems, in addition to its stacking and manipulation. The goal is to make sure every sample that complies with the standard remains sterile throughout its distribution cycle.
On one hand, ISO 11607 describes the key aspects of testing medical device packaging, including the classification of medical device packaging materials, testing the sealing process and the integrity of the seals of the entire package.
On the other hand, it includes the physical tests to be performed, which include burst, deformation, strain to failure, detachment and leak testing.
Finally, transport simulations are also required, so as to test the package’s resistance and ability to protect the goods from the hazards of the distribution cycle.
Besides, the ISO 13485 standard describes another important medical device packaging testing. In this case, the standard outlines the requirements for the Quality Management System (QMS) that applies to the control of medical products and medical devices. It thus outlines the standardized procedures that manufacturers and distributors must follow for the medical products to meet customer requirements and comply with applicable regulations.
It’s an essential standard for companies to prove that they are implementing best practices to achieve quality in their medical products, and that they have the ability to comply with the requirements and standards of the medical industry.
Personalized tests should be considered depending on the characteristics of the product itself and the real distribution cycle to be endured by the product.
In this case, it is common to use recording devices such as a Data Recorder, which provide real information regarding transportation conditions.
In addition to the tests mentioned above, other types of simulations can be performed, including:
- Compression tests using simulation equipment to measure the resistance of a package to compression forces.
- Rotational impact and drop tests in simulation systems to measure the protective capabilities of the package in a laboratory setting.
This medical device packaging test aims to simulate shelf-life ageing as it occurs in real life, anticipating the risks that storage might pose for medical products. Accelerated ageing tests typically include visual inspections as well as dye penetration testing, peel testing and sterile barrier tests (including burst testing). These are undertaken both before and after the determined storage time for testing in order to perform a comparative study.
>Seal Strength & Integrity
These types of tests aim to validate sterile barriers will be maintained for medical device packaging, including all the product’s estimated shelf life.
All of the aforementioned requirements must be taken into account when deciding on the medical packaging design. These processes are aimed at detecting potential risks linked to the distribution cycle with the purpose of redesigning or optimizing the package. This leads to a higher safety for the goods and a reduction in costs associated with damages during transportation.
Do you want to know more about how to optimize your pharma packaging? At Safe Load Testing Technologies we have a track record of over two decades in transport simulation for the packaging industry. Get in touch with us and let’s talk about how to improve the safety of your medical device packaging.