Global Packaging Validation for Medical Devices: FDA, EU MDR & NMPA
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作者:admin
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Date: 2025-06-26
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FDA recommends package test methods include simulated distribution and aging followed by associated packaging testing to demonstrate packaging materials can maintain sterile barrier integrity during device shelf - life. Device - specific performance testing for storage effects is needed. For double - barrier packaging, both internal and external systems should be tested. The text details various test items (Microbial Barrier Properties, Package Integrity, Package Strength, Simulated Transport), their standards, scopes, and test methods, such as using DIN58953 - 6 for microbial barrier properties, ASTM F1886/F1886M for visual inspection of package integrity, ASTM F88/88M for seal strength, and ASTM D4169 for simulated transport.
To demonstrate that the packaging materials can maintain the integrity of the sterile barrier during your device indicated shelf life, FDA recommends that package test methods include simulated distribution as well as simulated (and/or real-time) aging followed each by associated packaging testing, including package integrity, package strength, microbial barrier properties and so on. You should conduct device specific performance testing to determine whether storage (aging) may affect the performance of the device. Please be aware if the packaging of your device consists of a double barrier system, both internal and external packaging systems should be tested.
Test Item | Standard | Scope | Test Method |
Microbial Barrier Properties | DIN58953-6 | Porous materials. | Testing at moisture: Microorganisms are brought into drops on specimens. After drying the drops, it is investigated whether microorganisms have penetrated the underside of the specimens. |
Testing at dry: By cooling the air in the microbial barrier tester, which is sealed with the packaging material to be tested, an air flow (suction) enters a laboratory glass bottle. |
Package Integrity | Visual Inspection ASTM F1886/F1886M YY/T 0681.11 | This test method is applicable to packages with at least one transparent side so that the seal area may be clearly viewed. | Determinate channels in the package seal down to a width of 75μm [0.003 in.] with a (60-100) % probability. |
Vacuum Leak ASTM D(3078) | Determinate gross leaks in flexible packaging containing a headspace gas. | Test sensitivity is limited to 1×10−5 atm cm3/s (1×10−6 Pa m3/s) or even less sensitive. Small leaks may not be detected by this procedure. |
Dye Penetration ASTM F1929 YY/T 0681.4 | This test method is intended for use on packages with edge seals formed between a transparent material and a porous sheet material. The test method is limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. It’s require that the dye penetrant solution have good contrast to the opaque packaging material. | Detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent material and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. |
Package Strength | Seal Strength ASTM F88/88M YY/T 0681.2 | Measure the strength of seals in flflexible barrier materials. The test may be conducted on seals between a flexible material and a rigid material. | This test method measures the force required to separate a test strip of material containing the seal. It also identifies the mode of specimen failure. |
Withstand Internal Pressurization ASTM F1140/F1140M YY/T 0681.3 | Determine the ability of packages to withstand internal pressurization. Pressure differentials may occur during processes such as sterilization and transportation. | Brust Test: Packages are tested in apparatus that internally pressurizes the package until the package fails. The test measure is the maximum pressure detected before the package fails. |
Creep Test: Packages are tested in apparatus that internally pressurizes the package to a specified pressure and maintains that internal package pressure for a specific time. The test measure is pass/fail. |
Creep to Failure Test: Packages are creep tested and held until the package fails. The test measure is the time until failure. |
Simulated Transport ASTM D4169 YY/T 0681.15 | Test specimens consist of representative samples of complete shipping units, including actual contents. | Evaluate the ability of shipping units to withstand the distribution environment. |
