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Medical Product Packaging Design: A Responsibility and a Privilege

December 28, 2022

Medical device packaging plays a key role in protecting product safety and reliability: ensuring not only that sterility is maintained upon delivery to healthcare facilities and following prolonged storage, but also facilitating a simple opening process to prevent damage or contamination.

Since medical products often have unique specifications and usually require sterilization prior to packaging, medical packaging is made to both meet the highest medical standards and preserve the integrity of a product. Patient safety cannot be compromised, so the packaging must be carefully designed and manufactured.

Concept-to-Validation 

As stated previously, medical products can differ greatly, and each has its own features and requirements: from disposables, typically used at healthcare facilities in low-risk settings, to surgical products with high safety concerns. Consequently, as the first stage of every packaging process, Taryag recommends performing a detailed requirement analysis, which helps determine the type of packaging needed.

A Packaging design for medical products is dependent on the materials employed. In order to protect both the product’s mechanical integrity and its sterilization, packages should consist of two parts: a stiff polymer for physical preservation, and flexible, high-density synthetic flash-spun polyethylene fibers to ensure a complete seal, providing a protective covering that prevents the ingress of microorganisms and a serves as a sterile barrier.

Beyond materials, packaging solutions vary in size, from pouch size and design to blister packs. In particular, the increasing development and application of large medical products, which are often highly sensitive, require specialized packages and expertise. 

As part of the design and development process, medical packages must undergo meticulous tests to meet legal standards and quality control measures. These are known collectively as packaging validation. However, apart from the regulatory approval aspect, there is a wide range of benefits to conducting packaging validation. When a product reaches its customer, packaging validation ensures not only that it is protected, usable, and sterile, but that it’s easily identifiable, as well as convenient to open.

Packaging validation tests typically include: aging and shelf life testing, usability evaluation, a sterile barrier packaging integrity test, a bubble leak test, a dye leak test, a peel strength test, an underwater vacuum leak test, and more. 

Aging and shelf life testing is of particular importance, as it determines the ability of a package to endure over time by simulating the aging process. The simulation is carried out by storing the product in a temperature- and moisture-controlled incubator for a precalculated period. The aging process conditions are monitored, recorded, and analyzed in order to prove conformance with predetermined values. At Taryag, we operate multiple temperature-controlled incubators at different volumes, tailored to the product’s characteristics. 

Another key tenant of validation is transportation testing, which is performed by subjecting packages to the same forces and conditions encountered in real-world transit. It is a prerequisite for validating sterile medical devices, defined within ISO 11607. The vast majority of laboratories focus on either sterilization or transportation testing; however, as part of our integrated approach, Targyag’s ISO 17025-accredited and ISTA-certified laboratory provides both essential services within one facility.

Package Design and Manufacture at Taryag

Dedicated solely to the medical field, with a holistic understanding of the entire product life cycle, Taryag provides clients with superior, dependable packaging solutions which encompass the packaging process as a whole: from design to manufacturing services through validation.

Proud to play our part in promoting health and saving lives, our extensive experience with the medical device industry allows Taryag to step in at any stage of the packaging development process and keep your project moving forward, ensuring compliance with industry standards.

In addition to package design, manufacturing, and validation services, Taryag offers advanced sterilization solutions, providing medical device innovators with an end-to-end development infrastructure that helps remove barriers and reduce costs.