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Filling & Packaging 27.08.2020

Contipure AseptBloc DN now validated and filed to the US FDA

Krones is pleased to announce it has successfully completed the process of validating its Contipure AseptBloc DN system, and gained its approval from the US Food and Drug Administration (FDA).

Contipure AseptBloc DN now validated and filed to the US FDA
Earlier this year, the Krones Contipure AseptBloc DN obtained 3-A certification from the independent verifying organization 3-A Sanitary Standards. Now, the US Food and Drug Administration (FDA) has also confirmed that the Contipure AseptBloc DN reduces the risk of end-product contamination to an absolute minimum. (Photo: Krones)

Krones is pleased to announce it has successfully completed the process of validating its Contipure AseptBloc DN system, and gained its approval from the US Food and Drug Administration (FDA).

The Contipure AseptBloc DN is part of the standard aseptic equipment portfolio from Krones, and consists in a bloc configuration system with both aseptic filling and blowmolding of PET containers. Decontamination of primary packaging materials, consisting in preforms and closures, is performed with gaseous hydrogen peroxide (H2O2).

The system, already 3-A Certified, is now FDA approved for the filling of sterile low acid foods that can be stored and distributed at ambient temperature conditions. To gain the approval, the necessary validation activities were performed on the equipment by Krones, a third party process authority, and Krones’ major food and beverage partner and customer in the Midwest. All the required validation documentation, including multiple primary packaging material sizes and closures, was then satisfactorily received from the FDA.

Contipure AseptBloc DN is automatically cleaned and sterilized in less than two-and-a-half hours, providing its users the most line availability in the aseptic technology market. The system can also run continuous production without need of cleaning and sterilization cycles for over a week. All the sterile surfaces of the equipment are also sterilized with gaseous hydrogen peroxide, eliminating the need of hazardous chemicals and massive water consumption.

The state-of-the-art system from Krones also includes additional benefits such zero product waste at beginning of the production cycle, precise equipment high speed motion guaranteed by the integration of servo drives, and the best-in-class blowmoulding and filling expertise from Krones.

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