Medical Lab Services

Shelf-life

Package Integrity/Shelf-life

Accelerated/Real-time Aging Incubation and Testing

Packaged products are exposed to extreme conditions of temperature and humidity—the performance of the product and/or packaging is evaluated. 

Using specialized exposure chambers, Moog can expose products to the chosen accelerated aging conditions and at the conclusion of the exposure period evaluate the packaging and in the case of pharmaceutical products, perform stability indicating analyses of the active ingredients. Products that complete this exposure with no damage can be labeled with extended expiration dates, as described in ISO 11607 and AAMI TIR No. 17--1997.

Package/Container Integrity Verification

  • Sterility testing—uses the USP 40-item product immersion procedure described above under Pharmacopeial Sterility
  • Microbial aerosol challenge as recommended in ISO 11607
  • Seal leak test by dye penetration—ASTM F 1929. Aqueous dye is injected into the package near the seal and integrity of the seal is assessed visually
  • Package Burst Testing—ASTM F 1140. Air is injected into the sealed package and the pressure at which a seal fails is recorded. A modification of this procedure is called Creep to Burst Testing; in this test the package is pressurized to 80% of its theoretical burst value and held for a defined period of time. It is then further pressurized until it bursts and the final burst pressure is recorded
  • Seal Strength - ASTMF88. Peel Strength Testing of the seal to verify seal integrity/strength
  • Vial/Closure Integrity Testing
  • Distribution testing and others

Literature

ISO134852.pdf

Find More Literature

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