New PIC/S Recommendation PI 014-1: "Isolators used for aseptic processing and sterility testing"

GMP News No. 228

GMP News
27 August 2002

New PIC/S Recommendation PI 014-1
"Isolators used for aseptic processing and sterility testing"

After PIC/S published the draft of this recommendation for commenting bythe industry last year (GMPNews of 12 September 2001), the final version was published on 24 June2002. The recommendation came into force on 1 July 2002.

Like all PIC/S documents, this document, too, addresses inspectors ofsupervisory authorities. However, since it reflects the state of the artand as it shows which questions might arise in future inspections, it isalso of great interest to the pharmaceutical industry.

The history of the document was discussed in the GMPNews of 12 September 2001. In comparison to the draft, the generalstructure of the document has not changed (8 chapters with basicrequirements on 6 pages; a 14-page-long appendix with detailedinformation). Some of the chapters have been modified or expanded. In thefollowing we have listed the most important differences between the draftand the final version:

  • The final version gives more details regarding the requirements onisolators for sterility testing; whereas isolators used for productionhave to be located in a class-D cleanroom, those used for sterilitytesting only have to be placed in a controlled, but not necessarilyclassified room
  • The expression "sporicidal process" and the requirementsthat result from it are mentioned more often; a six-log reduction isnot defined, but is considered to be the state of the art
  • More emphasis is placed on maintenance (maintenance program), amongothers for gloves and gas generators
  • The sterilisation of the cooling zone at the end of a hot-airsterilisation tunnel is considered to be critical
  • A program to minimisethe risk of loss of integrity of gloves, sleeves and suits is required

  • A minimum of 10 Pascalpositive differential airpressure is recommended in contrast to the draft (15 Pascal)

  • The material to be sterilised should be identified, and therationale used should be documented
  • After testing the HEPA filters with dispersed oil, the first gassingshould be considered as neutralising operation
  • If studies have been carried to show that the lethality of thebioindicators on the carrier material is approximately as high as thelethality on the material to be sterilised, no in-house studies haveto be conducted
  • Generally speaking, the requirements on the use of bioindicators isdescribed in more detail than in the draft

The recommendation can be downloaded via the followinglink.

Dr Andreas Mangel


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