Validation of aseptic filling machines – Revision of VDMA Document No. 6

The IVLV/VDMA document “Hygienic filling machines of class V according to VDMA: Testing of packaging sterilisation devices for their efficiency” has been revised.

The document specifies test microorganisms for testing of sterilisation devices of this machine class and defines the procedure for carrying out a count reduction test or an end-point test.

This document was compiled in 2002 under the title ‘Testing of aseptic systems with packaging material sterilisation devices for their efficiency’ in the VDMA working group “Interface problems with aseptic systems” in consultation with the Industrievereinigung für Lebensmitteltechnologie und Verpackung e.V. (Industrial Association for Food Technology and Packaging). Compared to the previous version from 2008, the following changes were made:

• Restructuring of the trade association publication
• Alignment of definitions with other VDMA technical association publications
• Revision of the section “Requirements for test germs for testing packaging sterilisation devices for aseptic filling machines”.
• Revision of section “Procedure for inoculation of the packaging”.
• Revision of section “Germ reduction test” (additions to the practice with machines with multiple treatment stations)
• Revision of the section “Endpoint test” including the calculation example in the appendix (addition to the recommendation for the determination of the initial germination scale; additional criterion for the evaluation of the stability of the sterilisation process)
• Updating and addition of references
• Deletion of appendix “Growing conditions for Bacillus subtilis SA 22 and Bacillus atrophaeus and preparation of the spore suspension”.
• Update of annex “Sources of spore suspensions”.
• Additional appendix “Example of a sensitivity test of the spore suspension to the disinfection medium – using hydrogen peroxide as an example”.

The trade association publication is available in German and English and can be downloaded free of charge from VDMA.org using the link below.

An overview of all publications of the working group on the topic of low-germ and aseptic filling with links for free download is also available from there.