VDMA trade association publication no. 12 new edition

Date: 10.08.2020Source: VDMA

Guideline to Checking the Microbiological Safety of Filling Machines of VDMA Hygiene Classes IV and V

The guide contains an overview of the tests commonly used in practice to check microbiological safety, which are used for hygienic filling machines of classes IV and V according to VDMA. These are summarised in four groups, the most important differentiation criteria of which are worked out. The aim of this trade association publication is also to distinguish the so-called sterile test, which is carried out before a filling machine is released for commercial production, from other microbiological tests. In addition, Annex I specifies a standardised structure for the sterile test. This and the other Annexes are of an informative nature. Companies can adapt the structure of the sterile test for their facilities or define a different structure.

This trade association publication was subject to regular revision in 2020. Compared to the first edition, the following changes were made:

  • Adjustment of the pH value differentiation of acidic (pH value ≤4.6) and weakly acidic (pH value > 4.6) products to the differentiation of the FDA.
  • Addition of a section 3.3.6 ‘Integration of a sterile tank integrity test into the sterile test’
  • Updating of the bibliography and references in the text
  • Revision of Appendix I (informative) ‘Standardised sterility test according to VDMA’:
  • Insertion of a new Appendix IV (informative) ‘Procedure for carrying out a sterile tank integrity test’.

The publication was prepared by the working group “Interface problems with aseptic systems” of the VDMA Packaging Machinery Division. An English version is in preparation. This and other trade association publications published by the same working group are available as a free download at vdma.org/publikationen – branch “Food processing and packaging machines”.

David Cox / IDM

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