FDA okays low-acid aseptic blow-fill-seal filler

Following tests run at a dairy customer in North America, Sidel (Hünenberg, Switzerland) has received Food and Drug Administration acceptance for its low-acid Aseptic Combi Predis FMa blow fill seal filler to be used in the United States. The system is the world’s first aseptic PET filling equipment with dry preform sterilization approved by FDA.Sidel’s low-acid Aseptic Combi Predis FMa blow fill seal filler

“We are particularly proud of this FDA acceptance,” says Guillaume Rolland, Sensitive Products Director at Sidel. “It confirms our Aseptic Combi Predis design is compliant with the FDA’s current Good Manufacturing Practice (cGMP) requirements.”

FDA approval qualifies the Sidel aseptic solution with dry preform sterilization technology to produce and distribute shelf-stable low acid products in PET bottles for the US market.  

The successful completion of this extensive and exhaustive evaluation process confirms the performance of the other 100 Combi Predis lines in operation worldwide. Sidel’s key accounts, along with co-packers and local brands, have been manufacturing low- and high-acid products using PET line applications for nearly 10 years. The patented technology is 100% safe for the packaging of UHT milk, soymilk, coconut water, or teas in PET bottles, sold through the ambient chain market in the US and the rest of the world.

The Sidel Aseptic Combi Predis merges dry preform sterilization with aseptic blowing, filling and sealing functions within a single production enclosure. It differs from traditional aseptic technology because the package sterilization takes place at the preform rather than at the bottle phase.


Additional details

The Process Authority for the Sidel aseptic filler was Dover Brook Associates (DBA) of Chester, NY, which conducted a detailed review of the design, critical factors, and the sterile zone boundaries. The stringent validation tests were performed on a commercial filler producing aseptic UHT milk.

“We accumulated more science from these tests performed with DBA. They challenged and validated the process and the technology itself,” explains Arnaud Poupet, aseptic product and platform manager at Sidel. DBA concluded that the minimized sterile zone provided a safe and successful aseptic process that produced a commercially sterile, hermetically sealed bottle.

“DBA’s testing demonstrated that the sterile zone during the blowing process was the critical component, not the blow-molding zone itself, which was due to the Sidel patented dry-preform sterilization technology,” Poupet adds. The scheduled processes require minimal critical factors, which have to be monitored during the production, cleaning and sterilization phases of the aseptic process. The critical parameters are continuously monitored to ensure full production sterility, beverage integrity and food safety. “Our best warranty for food safety is simplicity, because a line with a small sterile zone and minimal critical factors is managed more safely, easily and effectively,” continues Poupet.

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