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

By: 
December 07, 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.

Not only is the bottle and closure sterilization process a completely dry one, but a seal sterilization feature is also based on H2O2. The isolator, after it has been cleaned with caustic and rinsing water, and then dried, also 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.

The machine has currently been validated for 48 hours of continuous operation, reports Krones, and then 3.5 hours of downtime are required for for cleaning and sterilizing the system. [email protected]

 

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