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The significance of package testing for medical devices cannot be overlooked, as it directly impacts the safe and intact delivery of the product to consumers. It is crucial to conduct the required tests and adhere to the necessary regulations.

Therefore, medical packaging design should be considered from the very beginning of the product development process.

Defining Package testing for medical devices:

Medical device packaging encompasses all packaging designed to meet the specific requirements posed by medical devices to withstand the challenges of the distribution cycle.

It serves as the primary safeguard against potential threats that could compromise these products, playing a vital role in maintaining their sterility.


Inadequate medical device packaging can lead to significant issues for both manufacturers and consumers. It is imperative that medical device packaging materials and the overall packaging system are resilient enough to endure transportation and storage conditions, ensuring that the products reach their destination with intact seals and no damage. Conversely, incorrect packaging configurations can result in financial losses and unsuccessful product launches.

Meeting Medical Device Packaging Requirements:

The responsibility of adhering to packaging requirements lies with the medical device manufacturer. Compliance is essential to ensure the protection of products during transit and alignment with health and safety regulations. Pharmaceutical and medical items possess unique characteristics, such as limited shelf life, necessitating transportation and marketing requirements tailored to their specific needs.

Safety protocols focus on aspects like seal integrity, material selection, and the package’s performance over time. Key regulatory bodies in this domain include the Food & Drug Administration (FDA) in the United States and the Medical Devices Directive in the European Union.

Beyond merely arriving intact at hospitals, clinics, or end customers, medical device packaging must endure prolonged storage, maintaining its integrity for years to prevent any alteration in the composition or efficacy of the enclosed drugs or devices.

Several medical device packaging protocols include:

  • ISO 11607 – Packaging standards for medical devices subjected to terminal sterilization.
  • EN 868 – Requirements and test methods for packaging materials and systems for sterilized medical devices.
  • ASTM D1585 – Guidance for testing the integrity of porous medical packages.
  • ASTM F2097 – Standard for designing and assessing primary flexible packaging for medical products.
  • ASTM F3475-11 – Guide for evaluating the biocompatibility of materials used in medical device packaging.
  • BS EN ISO 15378:2017 – Specific requirements for primary packaging materials for medicinal products, with reference to ISO 9001:2015 and good manufacturing practice (GMP).
  • ISTA 3 – Packaging and transport standards now officially recognized for FDA approval of medical devices in the US market.
  • ISO 11137 – A standard measuring Gamma and E-beam sterilization processes.

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 Procedures for Medical Packaging Design:

ISTA 1 Series
These tests assess the integrity and strength of the product-packaging combination without employing simulation to replicate real-world conditions.

ISTA 2 and 3 Series
These tests involve simulation to replicate various aspects of the shipping process, including environmental conditions, random vibration using vibration equipment, and drop tests from different heights.

ISO Tests
ISO 11607, a crucial standard for pharmaceutical and medical device packaging, provides a comprehensive framework for testing and evaluating medical packaging. This standard places significant emphasis on essential processes like sealing and closure systems, as well as stacking and handling. The primary objective is to ensure that every sample meeting the standard maintains its sterility throughout the distribution cycle.

ISO 11607 encompasses two key aspects of testing medical device packaging:

  1. Classification of Medical Device Packaging Materials: This part focuses on categorizing materials and assesses the sealing process and the integrity of the seals across the entire package.
  2. Physical Tests: These tests include evaluations for burst resistance, deformation, strain to failure, detachment, and leak resistance.

Package testing for medical devices: correct procedures

It’s crucial to conduct transport simulations to assess the package’s resilience and its ability to safeguard products during the distribution process.

Furthermore, the ISO 13485 standard delineates another significant aspect of medical device packaging testing. In this instance, it specifies the requirements for the Quality Management System (QMS) applicable to the control of medical products and devices. It establishes standardized procedures that manufacturers and distributors must adhere to in order to ensure that medical products meet customer demands and comply with relevant regulations. This standard is essential for companies to demonstrate their commitment to implementing optimal practices for ensuring the quality of their medical products and their capacity to adhere to industry standards and requirements.

Customized tests

Taking into account the unique characteristics of the product and the specific distribution cycle it will encounter, such tests may involve the use of data recorders to gather real-time transportation data.

Additionally, other simulation tests can be conducted, including compression tests using specialized equipment to assess package resistance to compression forces, as well as rotational impact and drop tests within controlled laboratory settings to evaluate package protection capabilities.

Accelerated Ageing

This is a medical device packaging test designed to replicate the aging process that occurs during real-world shelf-life, anticipating potential risks posed by storage conditions for medical products. These tests typically encompass visual inspections, dye penetration testing, peel testing, and sterile barrier tests, both before and after the specified storage duration, enabling a comparative analysis.

Seal Strength & Integrity tests

These tests are conducted to verify the maintenance of sterile barriers throughout the estimated shelf life of the medical device packaging.

All these requirements should be considered when determining the design of medical packaging. These processes aim to identify potential risks associated with the distribution cycle, with the ultimate goal of redesigning or optimizing the packaging. This approach enhances the safety of the products and reduces costs linked to transportation damage.

If you’re interested in learning more about optimizing pharmaceutical packaging, Safe Load Testing Technologies boasts over two decades of experience in transport simulation for the packaging industry. Feel free to reach out to us, and let’s explore ways to enhance the safety of your medical device packaging


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