Frequently Asked Questions

Distribution Simulation is a systematic and repetitious way of testing shipping containers, using testing equipment which exposes these packaging systems to genuine, real-life hazards that may ensue within the forthcoming distribution environment.

Accelerated Aging is an artificial procedure for establishing the lifespan or shelf life of a product in an expedited manner.

The test is conducted by placing the test item on a shelf and allowing it to be exposed to typical storage conditions. Doing this will establish the items accurate expiration date.

Conditioning atmospheres that are used prior to conducting transit simulation tests. The conditions are either historically accepted standard conditions or special laboratory conditions chosen to represent the distribution environment.

Package Validation Testing is vital to ensure integrity of the package’s seal. A packaging validation will provide assurance and security that a package is sealed properly, leak-free, and secure from any number of outside contaminants.

Visual inspection testing provides a qualitative (accept / reject) visual inspection method for evaluating the appearance characteristics of unopened, intact seals in order to determine the presence of defects that may affect the integrity of the package.

Peel Tests determine ‘Seal strength’ of the package, which is defined as the measure of the ability of a package seal to resist separation. The test results are not only related to package integrity, but also to measuring the packaging processes’ ability to produce consistent seals.

Burst testing provides a rapid means of evaluating tendencies for package failure when the package is exposed to a pressure differential. It is regularly used to assess packages during the manufacturing process and at various stages of the package life cycle. Pressure differentials may occur during processes such as sterilization and transportation.

Dye testing defines materials and a procedure that will detect and locate a leak equal or greater than a channel formed by a 50 μm (0.002 in.) wire in package edge seals formed between a transparent film and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time.

Determines package strength by pressurizing a package at a set percentage of the known burst pressure for a fixed amount of time.

The Bubble Leak test, which follows the ASTM F2096 standard, is conducted by visually inspecting for bubble streams caused from a defect in the packaging/sterile barrier system – all while it is submerged under water and gently pressurized.

Medical Package Testing

Details the elemental attributes demanded of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices. It takes into consideration the vast array of potential materials, medical devices, packaging system designs, and sterilization methods.

Describes the validation requirements for forming, sealing and assembly processes. The development and validation of packaging processes are crucial to ensure that sterile barrier system integrity is maintained until opened by the users of sterile medical devices.

Describes the standard practice for performance testing of shipping containers and systems. It provides a guide for the evaluation of shipping units in accordance with a uniform system, using established test methods at levels representative of those occurring in actual distribution.

Distribution Cycle 13 Air (intercity) and motor freight, local single package up to 150 lb.

Assurance Level. Determines the intensity of testing for distribution simulation.

Used to determine the rugged nature of medical packages and the effectiveness of its interior cushioning ability when the products/packages systems are exposed to impact during material handling operations.

Used to determine the ability of medical packages and products to withstand shock and vibration encountered during the entire transit course.