Krones, Neutraubling, Germany, said it successfully completed the process of validating its Contipure AseptBloc DN system and gained approval from the FDA.
According to the Krones, the Contipure AseptBloc DN is part of its standard aseptic equipment portfolio and consists of 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.
The system 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, Krones, a third-party process authority and Krones’ major food and beverage partner and customer in the Midwest performed the necessary validation activities on the equipment. All the required validation documentation, including for multiple primary packaging material sizes and closures, was then satisfactorily received from the FDA, Krones said.
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. Krones said the system can also run continuous production without need of cleaning and sterilization cycles for over a week.