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Technical Terms Glossary

Medical Package Testing

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.

Used to determine the maximum compression resistance and long-term stacking strength of both individual medical packages and their master shipping containers.

Sterilization & Validation

Living single cell w/out organized nucleus (>0.22 micron).

A test system containing viable microorganisms providing a defined resistance to a specified sterilization process

Physical removal of organic soil from an item to the extent necessary for further processing or for the intended use.

An agent that destroys pathogenic and other kinds of microorganisms by chemical or physical means. A disinfectant destroys most recognized pathogenic microorganisms, but not necessarily all microbial forms, such as bacterial spores.

A process that destroys pathogens and other microorganisms by physical or chemical means. Decontamination processes do not ensure the same margin of safety associated with sterilization processes. The lethality of the decontamination process may vary, depending on the nature of the disinfectant, which leads to the following subcategories:

a. High Level Decontamination: A lethal process utilizing a sterilant under less than sterilizing conditions. The process kills all forms of microbial life except for large numbers of bacterial spores.

b. Intermediate Level Decontamination: A lethal process utilizing an agent that kills viruses, mycobacteria, fungi and vegetative bacteria, but no bacterial spores.

c. Low Level Decontamination: A lethal process utilizing an agent that kills vegetative forms of bacteria, some fungi, and lipid viruses.

An agent that destroys microorganisms, especially pathogenic organisms. Other terms with the suffix –cide(e.g., virucide, fungicide, bactericide, sporicide, tuberculocide) indicate an agent that destroys the microorganism identified by the prefix.

Living (viable) organism.

A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device. (21CFR 880.2800(b))

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Validated processes used to render a medical device that has been previously used or contaminated, fit for a subsequent single use on another patient. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization.

A device intended for repeated use either on the same or different patients, with appropriate cleaning and other reprocessing between uses.

A SUD is a device that is intended for one use or on a single patient during a single procedure.

The dormant state of a microorganism, typically a bacterium or fungus, which exhibits a lack of biosynthetic activity, reduced respiratory activity, and has resistance to heat, radiation, desiccation and various chemical agents.

An agent that destroys all viable forms of microbial life.

State of being free from viable microorganisms.

A validated process used to render product free from viable microorganisms.

A sterilization wrap (pack, sterilization wrapper, bag, or accessories) is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. (21 CFR 880.6850)

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