FDA Letter of Non-Objection for dry-aseptics from Krones
Breakthrough in filling technology for low-acid aseptic products
Krones AG, Neutraubling, Germany, has received a letter of non-objection from the FDA for a rotary dry-aseptic PET-bottle filling system featuring H2O2 as the sterilising agent. This path-breaking development has so far been accomplished only by Krones, and will have been keenly noted well beyond the borders of the USA. 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. In order to evidence the requisite microbiological safety, the machine manufacturer has to have a validation procedure carried out by a "process authority" approved by the FDA. If this test is passed, the FDA will issue the letter of non-objection. This Krones has now achieved, with a rotary aseptic filling system in the low output category for one of Nestlé'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. Even the isolator, after it has been cleaned with caustic and rinsing water, and then dried, is sterilised in a dry process using evaporated H2O2 and not peracetic acid as had previously been the case. This innovation corresponds approximately to the procedure adopted in the pharmaceutical industry, and is an absolutely unique selling point for Krones' leading-edge technology.
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 filling 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.
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Press Officer KRONES AG
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