TESTING & VALIDATION OF MEDICAL DEVICE PACKAGING

Some of the medical device packaging protocols include:

• ISO 11607 Packaging for terminally sterilized medical devices.

• ISO TS 16775, “Packaging for Terminally Sterilized Medical Devices - Guidance on the Application of ISO 11607-1 and ISO 11607-2.”

• 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.

Notable changes to ISO medical packaging standards

Updates to ISO 11607 and ISO TS 16775, standards covering packaging for terminally sterilized medical devices, may help manufacturers comply with EU Medical Device Regulation set to go into effect next year.

With an application date of May 2020, the new EU Medical Device Regulation (MDR) is fast coming —a daunting prospect for medical device manufacturers. But updates (one published and one still undergoing revisions) to two standards covering packaging for terminally sterilized medical devices could help prepare the industry for compliance with the new European rules.

Revisions to ISO 11607-1/2 and ISO TS 16775 were written to harmonize with the General Safety and Performance Requirements (GSPR) contained in the EU MDR.

A provision in ISO 11607-1:2019, “Packaging for Terminally Sterilized Medical Devices — Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems,” directs packagers to complete a documented usability evaluation for aseptic presentation in either a real or simulated-use environment. That requirement is in line with the EU MDR directive that medical device manufacturers find ways to improve usability in case of unfavorable post-market surveillance feedback from end users.

Other notable changes in ISO 11607-1/2:2019 “Sterilization of Health Care Products—Packaging,” include the following:

• Formal inclusion of risk management.

• A new annex on ways to differentiate a sterile barrier system from protective packaging.

• A new section on visual inspection.

• A section on design changes and validation.

• A revised section on process validation that includes the new concept of a process specification.

• A new annex on environmental aspects according to ISO and CEN guidance.

The EN ISO versions have not yet been published, but Wagner said the EU committee in charge of EN ISO 11607 was set to meet with a consultant last month to work on harmonization with the EU MDR.

Also still under revision is ISO TS 16775, “Packaging for Terminally Sterilized Medical Devices - Guidance on the Application of ISO 11607-1 and ISO 11607-2.” A new effort is seeking to develop a symbol to enable users of sterile packaging to distinguish a sterile barrier system from a protective layer and help packagers comply with the EU MDR Annex I Section 23.3, which requires indication of a sterile barrier.

Testing Processes for Medical Packaging Design

Protocol ISO 11607 outlines the key aspects of pharma and medical device package testing.

On one hand, it describes the key aspects of testing medical device packaging, including the classification of the material, testing the sealing process and the integrity of the seals of the entire package. On the other, 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.

In summary, transport testing involves three types of tests:

1. ISTA 1 Series. Integrity performance tests without simulation to test the resistance and strength of the product-packaging combination.

2. ISTA 2 and 3 Series, as well as ASTM D 4169. These involve general simulation performance tests via simulation designed to mimic the conditions that may be experienced during the shipping process.

These include:

• Environmental conditions.

• Random vibration through the use of vibration equipment.

• Drop Tests from different heights.

3. A third type of personalized test, 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.

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.

For a more comprehensive review of the description of the various test protocols & relevant standards, please refer to the paper given in reference 4.

In packaging medical products that impact lives and health, the costs of poor-quality control can be enormous. In today’s fast moving global markets, the stakes are higher than ever. As competition and time pressures have grown, the industry and its regulator shave come to recognize that traditional testing method scan be slow and potentially risky. Package integrity testing has been acknowledged to be an important tool for ensuring the safety of package systems and the products they protect.

References:

1. The Wiley Encyclopedia of Packaging
2. www.safeloadtesting.com
3. www.packagingdigest.com
4. Packaging Testing for Medical Devices: Medical Plastics Data Service : March-April 2017 Pages28-29