Medical device packaging testing
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Stability testing and expiry dating of sterile barrier systems
ISO 11607-1, the central standard used by regulators to assess sterile medical device packaging, requires manufacturers to demonstrate the stability of sterile barrier systems through aging studies. Real-time aging is an integral part of every comprehensive assessment, while accelerated aging can be used to establish preliminary expiry dates and is typically sufficient to bring products to market before data from real-time studies become available.
Accelerated aging of medical device packaging is typically performed in accordance with ASTM F1980, an FDA-recognized consensus standard that is also widely applied in Europe. In a typical study, the packaging system is stored at elevated temperature for a relatively short period (such as three months) to simulate the effects of long-term ambient storage (for example, two years).
Both real-time and accelerated aging studies include periodic testing to confirm that packaging performance is maintained. Examples of parameters that can be assessed include the bioburden and sterility of the enclosed product, the mechanical durability of the packaging, and relevant chemical or material changes.
Aging conditions, test parameters, and pass/fail criteria are defined case by case based on the device, the packaging system, and the regulatory pathway. Our experts can help with this process to ensure that the results meet regulatory expectations.
Distribution testing of shipping containers
Medical device shipping unit performance during handling, storage, and transportation is typically assessed in accordance with ASTM D4169. The standard defines structured simulation protocols that expose packaging systems to the mechanical and environmental stresses encountered in distribution, including vibration, shock, compression, stacking loads, and varying temperature and humidity conditions. The goal is to demonstrate that the enclosed medical devices and their immediate packaging remain protected throughout the distribution cycle.
ASTM D4169 includes a range of distribution cycles and assurance levels that reflect the expected shipping environment, transportation modes, and the level of protection required for the product. Measurlabs’ experts can help select appropriate testing conditions to ensure that your packaging system meets relevant performance and regulatory expectations.
Questions?
Testing Expert Elina Tenhunen is happy to provide more information about our services.
All medical device packaging tests in one place
Measurlabs combines in-house expertise with a wide network of ISO 17025-accredited partner laboratories to deliver all required packaging tests through one point of contact. This means that clients benefit from consistent expert support and regulatory-ready results without the hassle of working with multiple laboratories.
Beyond aging studies and distribution testing, the following are some examples of additional tests we offer for medical device packaging:
Microbial ranking of porous packaging materials according to ASTM F1608
Packaging integrity and mechanical durability tests, such as seal strength, puncture resistance, bursting strength, and tensile properties
Assessment of barrier properties, including water vapor transmission rate (WVTR) and oxygen transmission rate (OTR) measurements
Chemical analyses and migration tests to verify material safety and ensure the packaging does not adversely affect the product
We also provide a comprehensive range of testing services for medical devices themselves, including biocompatibility, sterility, and cleaning validation. Do not hesitate to ask us for more information or a quote.
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