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erman Krones has received a letter of non-objection from the US FDA for a rotary dry-aseptic PET-bottle filling system featuring H2O2 as the sterilising agent. The company says this development has not been accomplished by other bottling line makers.

The 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 is what Krones has now achieved, with a rotary aseptic filling system in the low output category for one of Nestlé's research centres in the US.

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 to the procedure adopted in the pharmaceutical industry, says Krones.