Non-destructive vacuum decay method for PFS closure integrity testing

Non-destructive vacuum decay method for PFS closure integrity testing

The following article was published on Pharma World Magazine on April 30th, 2015. “Non-destructive vacuum decay method for pre-filled syringes closure integrity testing”.

The case study, investigated the capability of the LF-S equipment to detect simulated defects of different sizes and types on PFSs and to quantify the false-result rates. VDM process indicators as:

  • Detection Rate of Positive Controls (DR PC);
  • Detection Rate of Negative Controls (DR NC),
are determined and:
  • False-Negative Rate FNR = 1- DR PC;
  • False-Positive Rate FPR = 1- DR NC.
are obtained.
The following link takes you to the complete article published on the Pharma World Magazine: http://www.pharmaworldmagazine.com/current-practices-challenges-new-developments/

download pdf


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