Package Testing & Validation
Package Testing & Validation
Regulatory agencies’ concern for labeling and packaging of a medical device leads to product quality scrutiny. Medical device 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.
Our technical experts approach these validations by looking at the components of the packages both individually and as a whole. The 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 incorporates the aging of the product packaging to support shelf life stability and product expiration labeling. In addition, our validation design will verify package integrity, seal strength and burst properties evaluation, and distribution of the final finished devices – whether boxes or cartons delivered remain 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 will determine the strength of a specific area of the seal for a medical device package.
Burst Strength [ASTM F 1140]
This method is used to determine a package’s ability to resist internal pressure and is a measure of 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 or FPA/SPMC 005-98)
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.
Compression Test [ASTM D 642]
This method covers compression tests on shipping containers (e.g., boxes and drums), their components, or both.
Drop Test [ASTM D 5276]
This method is used in evaluating the capability of a container to withstand the sudden shock resulting from a free fall, or to evaluate the capability of a container and its inner packing to protect its contents during the sudden shock resulting from a free fall.
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.
Liquid Dye Immersion [USP <1207.2> and USP <381>]
This method is used to detect failures, such as cracks, seams, and laminations through leaks or lack of fusion. The dye immersion method can be used on various types of materials, such as nonporous, metallic materials (ferrous and non-ferrous) and nonmetallic materials (glazed ceramics, certain nonporous plastics, and glass).
Whole Package Microbial Aerosol Challenge with Sterility Test
This microbial barrier test evaluates the ability of an intact, production package to maintain its sterile barrier until it reaches its end of use point. In the test chamber, the package is subject to an aerosol challenge, which may be performed under dynamic or static conditions.
Whole Package Microbial Talc Challenge with Sterility Test
This microbial barrier test is used to evaluate the ability of an intact, production package to maintain its sterile environment until it reaches its point of end use.
Microbial Ingress / Immersion Challenge
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 environment. 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.
Transportation Simulation Test [ISTA Project 1A, 2A and 3A]
These tests provide a means for manufacturers to predetermine the probability of the safe arrival of their packaged products at their destination through the utilization of tests developed to simulate the shocks and stresses normally encountered during handling and transportation.
Thermal Controlled Transport Packaging Test [ISTA 7D]
This method covers the thermal performance testing of packaged products to evaluate the effects of external temperature exposure.
ISTA Environmental Conditioning [ISTA Series]
Temperature cycling sequence.
ASTM Environmental Conditioning [ASTM D4332]
This practice is used to simulate particular field conditions that a container, package or packaging component may encounter during its life or testing cycle.
Accelerated Aging / Shelf Life Expiration Dating Studies (ASTM F 1980)
Accelerated Aging is a key component of the overall packaging validation for medical devices. Following ISO 11607, a package validation includes accelerated aging and the corresponding integrity testing as well as simulated distribution and its subsequent integrity testing.
Accelerated aging serves as key interim data to support product shelf life dating until real-time data is available. One way we would work with you would be to provide a recommendation to age additional samples—if appropriate and if chamber space would allow. This additional aging may be useful in the event of a future issue to support shelf life extension or supplemental data.