LFC Technology for CCIT on Pre-filled Syringes In-Line and the validation approach

Abstract

  The increasing expectations of CCI inspection in any kind of pharmaceutical product has been also observed for pre-filled syringes.
  Beside the single testing stations, a high speed solutuion has been developed and designed.
  A non-destructive deterministic CCI testing method suitable for detection of leaks in pre-filled syringes will be shown as well as their performance and validation approach at high speed conditions.
  Statistics comparing sensitivity, repeatability and separation of pass/fail will be shared as well as a discussion about the validation approach when testing prefilled syringes (PFS) in a deep vacuum decay testing cycle.