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FDA-validated dry-aseptic filling system; photo: Krones AG
14 January 2010

FDA Letter of non-objection for dry-aseptics

In December 2010, Krones 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.

The system works in the low output category and has been installed in a Nestlé research department in the U.S.

In a complete dry process, bottle and closure sterilisation as well as sterilisation of seal and isolator (after caustic CIP) are based on the use of evaporated H2O2 instead of peracetic acid which had formerly been used.

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.