Package Testing and Validation
Regulatory agencies' concerns for labeling and packaging of a medical device lead to product quality scrutiny. Package validations are a key component of all medical device design history files and regulatory submissions. Whether the device is sterile or nonsterile, packaging of the product to ensure it arrives as intended is of the utmost importance.
Packaging validation consists of three components: package and seal integrity testing, accelerated aging or shelf life stability, and simulated distribution testing. Our validation and ongoing testing incorporate the aging of the product packaging to support shelf life stability and product expiration labeling. In addition, our validation design will evaluate package integrity, seal strength, and burst properties, to verify that during distribution of the final finished devices - whether boxes or cartons - the packaging remains intact.
- Seal Integrity Testing
Regulations dictate that the seal strength and specification limits be determined for pre-sterilization sealer performance verification (high, low, and standard parameter settings) and seal strength consistency qualified for post-sterilization production, shipping, and shelf-life qualifications.
Seal Tensile Strength [ASTM F 88]
This method determines the strength of a specific area of the seal for a medical device package.
Burst Strength [ASTM F 1140]
This method determines a package's ability to resist internal pressure and measures the strength of the package seals.
- Package Integrity Testing
Regulations require the integrity of sterile packages be maintained during the production, shipping, and shelf life of the product. Physical testing for package leaks has been shown to be more sensitive than the microbial challenge test and is generally the preferred method.
Bubble Emission Test [ASTM F 2096]
This method, which covers the determination of gross leaks in flexible packaging, is applicable to nonporous packaging and to porous packaging that has its porous component sealed using a blocking agent. It is used to detect leakage of air through a channel in the seal or pinhole in the package.
Dye Penetration [ASTM F 1929]
This method, which covers the determination of gross leaks in flexible packaging, is applicable to porous and nonporous medical device packages. It is used to detect small leaks in materials or seals of packages where harmful biological or particulate contamination may enter.
Microbial Barrier Test [DIN 58953-6:2016]
This microbial barrier test is used to assess the ability of a non-porous package to provide a microbial barrier.
- Transportation/Distribution Simulation Testing
Manufacturers must adequately evaluate the ability of the package and shipper to protect the product through the handling, shipping, and distribution environments. Damage such as puncture, abrasion, and seal failure may result.
Distribution Simulation Shipper Test [ASTM D 4169 - DC 13]
This test method is performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements (e.g., shock, drop, vibration, or compression) that are encountered in various distribution environments.
If you have additional questions about the test, or would like to consult with the experts at Biolink, ASK OUR EXPERT