American graduation exam for the Contiform AseptBloc
It was four years ago that we premiered the Contiform AseptBloc. Meanwhile, some models of this bloc system, comprising a stretch blow-moulder and a filler, are up and running worldwide, have been successfully validated, and are filling a wide range of different aseptic products. Up to now, however, we’ve not able to place a system in the USA.
Why exactly is that?
In the USA, the filling of weakly acidic products is regulated by the FDA (Food and Drug Administration). In order to put a system on the market for bottling these products in the USA, its design and its microbiological validation data have to be rigorously checked by the FDA. This testing by the FDA is acknowledged in the sector as the most stringent standard for the safety of an aseptic filling system. When interacting with government agencies, machinery manufacturers are supported by what are called “process authorities”, which renders the procedure a whole lot easier for firms like Krones.
In the shape of the PET-Asept D, an aseptic bottling system for the small output range featuring a different process sequence, Krones had in 2007 already succeeded once in overcoming this obstacle.
In the past, however, some machinery manufacturers failed to obtain an approval from the FDA, and the machines the client has purchased could not be used for the filling purpose originally intended. So understandably enough, bottling firms are rather sceptical when it comes to new system concepts.
In order to prove that the system does indeed meet the requirements involved, there is an option for obtaining what is called a “proof of concept” beforehand. Here, together with the process authority, a design review and all steps in the validation procedure are carried out as exemplified by an existing machine.
All the empirical feedback from 300 PET-Asept systems and the first system for the USA, the PET-Asept D, has now been incorporated in the design concept for the Contiform AseptBloc. The philosophy here has always been: keep it simple, keep it safe. So meanwhile, in conjunction with the Dover Brook Associates company, the proof of concept has meanwhile been approved without difficulty – precisely as we had hoped and expected.
So there’s nothing to stop a triumphal progress of the Contiform AseptBloc on the USA’s aseptic market, wouldn’t you say?