Package testing and package validation are essential for getting your product to the market. Our labs work with clients provides authoritative expertise, superior testing services and fixed-base project quotes.
- Distribution simulation tests evaluate each package`s ability to protect the product devices without defect or loss of sterility throughout the handling, distribution and storage environment.
- ASTM D 4169 Standard Practice for Performance Testing of Shipping Containers and Systems is performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements (e.g. shock, drop, vibration, compression) which are encountered in various distribution environments. The Distribution Cycle (DC) most commonly used for medical device packages is DC 13 which is designed for the small parcel and overnight shipping mode.
- ISTA (International Safe Transit Association) Pre-Shipment Test Procedure is a series of tests that predetermine the probability of the safe arrival of packaged products at their destination through tests that simulate the shocks and stresses encountered during handling and transportation.
- Physical Package Integrity Tests: To maintain the sterility of an enclosed product until it reaches its point of end use, the packaging must provide a microbial barrier in the post-sterilization environment. Sterile package integrity must be maintained under the rigors of distribution, storage, handling and aging for the claimed shelf-life of the medical device. Tests used to satisfy these requirements evaluate the material performance and the whole, finished package.
- ASTM F 1608 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. The exposure chamber method determines the microbial barrier properties of porous materials, which helps assess the potential of a one porous material to contribute to the loss of sterility of the contents of the package in comparison with that of another porous material.
- Intact Package Microbial Barrier Test (Porous Packages) is used to evaluate the ability of an intact, production package to maintain its sterile environment until it reaches its point of end use. The procedure includes an aerosol challenge in a test chamber, package exterior decontamination, and subsequent sterility testing to determine the presence of the indicator organism.
- Microbial Ingress for Non-Porous Packages (Immersion Challenge Method) is a method to asses the ability of a non-porous package to provide a microbial barrier. Packages containing sterile growth medium are immersed in a buffer solution containing a known concentration of an indicator organism. After the challenge, the packages are dried under laminar flow, then incubated and inspected for growth of the indicator organism.
- Physical test methods (shock testing, vibration testing, mechanical testing, leak testing) may be used to validate that physical package integrity has been maintained throughout the packages processing, expected shelf life, and handling. They include ASTM F 1929 Package Leak Testing by Dye Penetration and ASTM D 3078 Package Leak Testing by Bubble Emission.
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