Dry-aseptic filling gets FDA OK for low-acid aseptic products

08/12/2010

Processors blowmold bottles or injection mold closures, and don't handle bottle filling—but knowing your customers can switch to dry-aseptic filling could impact the design on your parts. Beverage bottle filling labelling equipment manufacturer Krones (Neutraubling, Germany) received a letter of non-objection from the FDA for a rotary dry-aseptic PET-bottle filling system featuring H2O2 as the sterilising agent.

Krones claims to be the only company as yet offering this new filling variant with a line that meets FDA requirements. The U.S. 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. This test was passed using a rotary aseptic filling system for one of Nestlé's research centres in the U.S., and the FDA issued its letter of non-objection....
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