Medical packaging must maintain its protective performance during transport, storage and use. Seal integrity, environmental and ageing tests provide demonstrable evidence of safety. This results in a validated packaging solution that meets relevant standards and regulations.
Medical packaging cannot be declared safe based on a single standard test. The appropriate testing strategy depends on the type of packaging, the medical device, the sterilisation method, and the conditions encountered during storage, transport, and use. A distinction must also be made between the sterile barrier system, which prevents contamination, and the protective transport packaging surrounding it.
At Faes, we therefore assess not only the packaging as a product, but the entire use and logistics chain. We translate risks such as shocks, vibrations, moisture, contamination, and incorrect handling into a substantiated packaging design and an appropriate testing and validation plan.
Packaging for a medical device must demonstrably continue to perform until the moment the product is used. For terminally sterilised devices, this means that the sterile barrier system must maintain sterility. The outer packaging must also prevent the device or the sterile barrier from being damaged during transport, storage, and handling.
A defective seal, perforation, inadequate fixation, or material degradation can lead to contamination, damage, or loss of functionality. This may affect patient safety, product release, continuity of supply, and the manufacturer’s liability. Safety testing is therefore not merely a final inspection, but an integral part of risk management and design validation.
In many Faes projects, the challenge is not to develop the primary sterile barrier itself, but to protect the complete medical system surrounding it. For example, we design reusable cases, custom interiors, and transport solutions that prevent sensitive equipment or validated inner packaging from being subjected to excessive loads or damage during transport.
The required tests are determined through a risk analysis. Not every package needs to undergo every test. A lightweight case intended for internal hospital use is exposed to different risks than packaging that is transported internationally, cleaned repeatedly, or used under changing climatic conditions.
For sterile barrier systems, tests are performed to determine whether seams and seals are sufficiently strong, uniform, and leak-tight. Depending on the material and construction, methods may include visual inspections, seal-strength measurements, dye penetration tests, and leak-detection tests.
These tests do not all assess the same characteristics. A seal-strength test measures mechanical strength, while a leak test identifies open channels, perforations, or other defects.
Packaging may be subjected to drop tests, vibration, shock, compression, and stacking loads. Temperature and humidity conditioning may also be necessary when materials or products are sensitive to climatic fluctuations. A distribution simulation must accurately represent the actual route, modes of transport, handling events, and storage conditions.
After such a simulation, it is not sufficient to check whether the outside of the packaging still looks intact. The fixation, the medical device, the seals, and the overall packaging integrity must also be reassessed. This determines whether the packaging has genuinely retained its protective function.
For packaging with a defined shelf life, real-time ageing and, where appropriate, accelerated ageing are used. For reusable packaging, use cycles are particularly relevant, including opening, closing, cleaning, disinfection, transport, and repair. Testing must reflect the intended service life and actual conditions of use.
At Faes, we take this operational context into account from the engineering phase onwards. We consider material selection, fixation, ergonomics, cleanability, replaceable components, and manufacturability. This results not only in strong packaging, but in a solution that remains practical and effective in day-to-day medical logistics.
ISO 11607-1 specifies requirements for materials, sterile barrier systems, and packaging systems for terminally sterilised medical devices. ISO 11607-2 focuses on the validation of forming, sealing, and assembly processes. Since 2023, both parts have placed greater emphasis on risk management.
ISO 11607 does not automatically apply to every medical transport package. For cases and other transport solutions, additional test methods from organisations such as ASTM or ISTA may be relevant. The required tests depend on the medical device, the intended environment, the logistics route, and the function of the packaging.
In Europe, the Medical Device Regulation, or MDR, provides the legal framework for medical devices. Harmonised standards can help demonstrate compliance with specific requirements. CE marking, however, is the result of a broader conformity assessment and is not a separate packaging test.
In the United States, the FDA Quality Management System Regulation has applied since 2 February 2026 and incorporates ISO 13485:2016.
Biocompatibility is only relevant when substances from the packaging could migrate into the medical device. The need for additional testing is therefore determined separately for each application.
Effective testing does not begin in the laboratory, but with a well-defined set of requirements. We therefore work with the customer to identify the product, its vulnerabilities, the logistics route, the use environment, the cleaning method, and the applicable standards. Based on these requirements, we develop and specify the packaging solution.
Faes combines custom engineering with packaging development, production, and assembly. Where necessary, we provide support with system integration, test selection, prototypes, test preparation, and documentation for standardisation or certification. We align the construction, interior, and materials with the loads that the solution must withstand in practice.
This integrated approach prevents packaging from being tested only at the end of the development process and then having to be redesigned. By considering test criteria, production, handling, and service life at an early stage, a robust, consistently manufacturable, and practical solution can be created.
Safety testing of medical packaging requires more than a series of isolated tests. The testing strategy must demonstrate that the packaging system continues to perform its intended function during sterilisation, storage, transport, ageing, and use, insofar as these conditions apply to the specific application.
At Faes, we approach this as both an engineering challenge and a supply-chain challenge. We do not simply deliver a case, crate, or interior. We help translate the need for protection into a manufacturable design, clear specifications, and appropriate verification.
In this way, packaging becomes a manageable component of quality, compliance, and reliable medical logistics.
Carlo Leijten is an account manager at Faes specializing in medical applications and audiovisual equipment. He helps customers in these plastics industries develop customized packaging solutions that meet stringent requirements for protection, cleanability and mobility.
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