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Contract Cleanroom Assembly and Packaging

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Phone : (714) 694-0348
E-mail : Info@SpecialTeam.com

An ISO and FDA Registered Facility: ISO 13485:2003 | FDA Registered 2032092

Medical Device & Package Testing Services

Testing Services

Medical Device Testing

Sterility assurance level (SAL) is a term used in microbiology to describe the probability of a single unit being non-sterile after it has been subjected to the sterilization process. SAL is used to describe the killing efficacy of a sterilization process, where a very effective sterilization process has a very high SAL.

Sterilization of medical devices and ensuring that biological products are not contaminated with harmful agents requires stringent testing procedures to isolate and identify any existing contaminants.

Medical Package Testing

Medical device manufacturers are called upon to obtain approval on each medical device package per ISO standard 11607. Package Validation Testing is vital to ensure integrity of the package's seal. Validation will provide assurance and security that a package is sealed properly, leak-free, and secure from any number of outside contaminants. Accelerated aging should take place after the integrity of the product and package has been determined.

The main culprit for feeble package strength is the seal-sealing parameters. If a formal validation of the sealer is not carried out, the medical device manufacturer can expect failure. Packages may also lose their integrity as a result of the various events that occur during processing and / or distribution. Package Validation Testing may be used to validate that the package integrity has been maintained throughout the package's processing, expected shelf life, and handling.

At SpecialTeam, testing includes (but is not limited to):

  • Visual Inspection - ASTM F1886
  • Peel Strength - ASTM F88
  • Dye Penetration - ASTM F1929
  • Accelerated Aging Package Validation testing - F1980-07 (2011)

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