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Krones letter of non-objection.

Krones has received a letter of nonobjection from the FDA for a rotary dry-aseptic PET-bottle filling system featuring H2O2 as the sterilising agent.


The American Food and Drug Administration (FDA) test includes verifying microbiological safety when filling low-acid aseptic products in the range from pH 4.6 to pH 7. If this test is passed, the FDA will issue the letter of nonobjection. This Krones has now achieved, with a rotary aseptic filling system in the low output category for one of Nestle's research centres in the USA.

Krones is thus the first bottling line manufacturer able to provide a complete dry process featuring H2O2 in strict compliance with the stringent stipulations applying in terms of sterilisation performance, residual concentration and shrinkage. Not only is the bottle and closure sterilisation process a completely dry one, but a seal sterilisation feature is also based on H2O2.

The downtime required for cleaning and sterilising the system has consequently been minimised. The machine has currently been validated for 48 hours of continuous operation. The cleaning and sterilisation process after this period takes a mere 3.5 hours.

With its FDA-compliant aseptics, Krones has succeeded in providing a completely dry PET-bottle tilling system for low-acid products in a rotary system using a continuous, easily mastered process, while reliably achieving the stipulated values for sterilisation performance and residues and at the same time significantly reducing the client's operating costs.

Contact Krones on tel 01942 845000 or visit
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Title Annotation:Packaging
Publication:Food Trade Review
Date:Feb 1, 2011
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