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Container Closure Integrity Testing

CCIT1000

The USP <1207> provides guidance on the integrity assurance of nonporous packages intended to hold sterile pharmaceutical products. The documents provides background instruction about leak and how to test for leak tightness. The documents gives guidance about the evaluation of the Maximum Allowable Leakage Limit (MALL), this strongly depends on process, package, testing procedures and it is evaluated and determined by the user. ASTM is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Some 12,575 ASTM voluntary consensus standards operate globally.

Specifically the ASTM F2338 describes the procedure for leak testing of packages giving guidance about the approach for a method development.

CCI 1000 is the new , state of the art, vacuum decay based, testing instrument capable to measure on various types of containers made of glass, plastic, metal, flexible composite

  • Liquid filled ampoules
  • Sealed Vials (empty, Liquid or lyo filled)
  • Pre-filled syringes (liquid filled or empty)
  • Pouches and sachet
  • Bottles, filled and sealed
  • Bulk containers small size
  • Ophtalmic dropper tip