Package Integrity

Accelerated aging studies (sometimes referred to as extended shelf life testing) are performed by iuvo BioScience for clients who wish to be able to market their product more quickly than real-time stability studies would permit.

The design of these studies, which are performed in parallel with real-time aging studies, is based on ASTM F1980, and exposes both products and packaging to extremes of temperature and humidity. iuvo maintains both walk-in incubators and smaller test chambers specifically for these projects. All chambers are equipped with automatic phone-out temperature and humidity alarms, and we maintain an on-site electrical generator to minimize any interruptions in the aging studies. Temperature and relative humidity data are captured and stored electronically over the course of the study.

Combining Accelerated Aging with Product and Packaging Testing

Our package integrity testing program is available to clients who perform the accelerated aging and real-time incubation studies at our facility or elsewhere. Comprehensive capabilities (listed below) of available package testing protocols includes both the standard dye migration and creep to burst physical tests and additional microbiology aerosol challenge tests in which sealed packages are exposed to a suspension of B. atrophaeus and the package contents assayed for ingress of the organism.

In addition, iuvo BioScience is one of the few test facilities able to examine the properties of porous packaging materials by the ASTM F1608 microbial ranking method. In the case of pharmaceutical products, stability indicating analyses of the active ingredients can also be performed.

Package/Container Integrity Verification

  • Sterility testing - Uses the USP product immersion procedure

  • Microbial aerosol challenge – ISO 11607
  • Seal leak test by dye penetration – ASTM F1929
    • Aqueous dye is injected into the package near the seal and integrity of the seal is assessed visually
  • Package burst testing – ASTM F1140
    • 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 testing – ASTM F88
    • Peel strength testing of the seal to verify seal integrity/strength.
  • Vial/closure integrity testing
  • ASTM distribution testing and others
  • Stability studies for pharmaceuticals, including:
    • Sterility
    • Identification
    • Closure integrity
    • Potency
    • Other chemical and biological assessments
  • Microbial Ranking of Porous Packaging Materials - ASTM F1608

Tests

Accelerated Aging
Aerosol Challenge (Not Including Sterility Transfer)
ASTM F1140 Burst/Creep Testing (per sample)
ASTM F1929 Dye Testing (per sample)
ASTM F88 Tensile Testing (per pull)
Microbial Ranking ASTM F1608 (Dilution)
Microbial Ranking ASTM F1608 (Direct Plate)
Packaging Aging
Shelf Life Determination