US FDA approves GEA’s aseptic technology

USA – The U.S. Food and Drug Administration (FDA) has awarded GEA a letter of no objection (LONO) for its ABF 1.2 technology, an integrated blowing, filling and capping solution featuring a fully aseptic rotary blowing machine.

According to GEA, that is the only system equipped with a 100% aseptic blower that is allowed to produce shelf-stable low acid (LA) beverages free from preservatives for distribution at ambient temperature in the U.S. market.

The GEA solution is based on an integrated blowing, filling and capping process that runs within a 100% aseptic environment.

With the help of the microbiological isolator, GEA ABF 1.2 aseptically blows preforms that have been previously treated with hydrogen peroxide vapor (VHP).

The result is a single zone sterilization process that requires no water and significantly fewer chemicals.

“The FDA certification is an accolade for the ABF 1.2 technology – the world’s first fully aseptic blow-fill-cap system,” said Alessandro Bellò, Head of Blowing, Filling and Packaging applications at GEA.

“For us technology developers, food safety is our highest priority.

That is why we have developed the GEA ABF 1.2, which erases the risk of recontamination of any drinks during filling through fully automated operations.

With ABF, we achieve a full decontamination process control that is unique in the market.”

The FDA testing is considered one of the most comprehensive validation protocols available in the aseptic beverage market.

Their stringent requirements ensure enhanced product safety, and their approval is highly valued even outside the U.S.

The FDA clearance confirms that GEA’s ABF 1.2 technology ensures maximum sterilization efficiency and reliability during every step of sensitive beverage bottling.

GEA successfully passed the validation tests which were performed on an ABF 1.2 system installed in the U.S. – and which is now already producing and delivering shelf-stable liquid dairy products to the North-American market.

“How do we manage to maintain complete sterility during operations?” said GEA Product Manager Massimo Nascimbeni.

“We achieve this by placing the aseptic blowing wheel in the same sterile zone where the filling and capping processes are performed.

The newly blown sterile bottles are transferred to the filling and capping carousels without leaving the sterile zone.

That’s why we don’t need any unnecessary H2O2 carry-over in the following modules.”

Beverage producers can completely monitor and control the preform sterilization process with the unique GEA Smart Sensor, which checks the spraying performance of each sterilization nozzle just before the preforms are treated.

The environmental sterilization process is completely automated requiring no manual intervention from the operator, therefore greatly decreasing any risk of system recontamination.

GEA added that it is currently the only supplier in the world able to provide both PAA- and H2O2-based sterilization technologies that are FDA approved.

GEA’s latest FDA approval was made easier in part due to its extensive experience in filing FDA projects – its first FDA certification having been awarded more than ten years ago for its PAA-based bottle sterilization platform, and given the number of installation references GEA has in the U.S. without a single bottle claim.

“Without a doubt, aseptic technology is the safest and most efficient production system for bottling sensitive beverages without preservatives, which never shies away from comparing costs and benefits.

The higher the production volumes, the higher the desired production quality and the higher the need for flexibility in bottle design, the clearer the advantages of aseptic systems become when compared to other solutions.

With our ABF 1.2 FDA certification we can finally service customers with VHP based sterilization platforms in the U.S,” concluded Bellò.

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