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 by the industry last year (GMP News of 12 September 2001), the final version was published on 24 June 2002. The recommendation came into force on 1 July 2002.

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

The history of the document was discussed in the GMP News of 12 September 2001. In comparison to the draft, the general structure of the document has not changed (8 chapters with basic requirements on 6 pages; a 14-page-long appendix with detailed information). Some of the chapters have been modified or expanded. In the following we have listed the most important differences between the draft and the final version:

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

  • A minimum of 10 Pascal positive differential air pressure is recommended in contrast to the draft (15 Pascal)

  • The material to be sterilised should be identified, and the rationale used should be documented
  • After testing the HEPA filters with dispersed oil, the first gassing should be considered as neutralising operation
  • If studies have been carried to show that the lethality of the bioindicators on the carrier material is approximately as high as the lethality on the material to be sterilised, no in-house studies have to be conducted
  • Generally speaking, the requirements on the use of bioindicators is described in more detail than in the draft
  • ECA organises the following events in this field/context:

    The recommendation can be downloaded via the following link.

    Dr Andreas Mangel

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