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Sidel Aseptic Combi Predis FMa blow fill seal filler received USFDA approval for low acid product manufacturing in the US.
Sidel Aseptic Combi Predis FMa blow fill seal filler received USFDA approval for low acid product manufacturing in the US.

Sidel has received US Food & Drug Administration (FDA) approval for its Aseptic Combi Predis FMa blow fill seal filler following tests run at a dairy customer in North America.

This means that the Sidel Aseptic Combi Predis FMa polyethylene terephthalate (PET) filler is validated for low acid manufacturing and commercial distribution in the US market.

It is said to be the world's first aseptic PET filling equipment with dry preform sterilization approved by FDA.

"We are particularly proud of this FDA acceptance," explained 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."

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.

Sidel Aseptic Combi Predis merges dry preform sterilization with aseptic blowing, filling and sealing functions within a single production enclosure and respects the fundamental concept which underpins aseptic packaging rules: producing a commercially sterile product, filled in a sterile zone, in a previously sterilized package.

It differs from traditional aseptic technology because the package sterilization takes place at the preform rather than at the bottle phase.

The company said this regulatory acceptance demonstrated that its 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 Process Authority for the Sidel aseptic filler was Dover Brook Associates (DBA), 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, and all the tests were successfully passed.

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," explained Arnaud Poupet, Aseptic Product and Platform Manager at Sidel.

The scheduled processes require minimal critical factors that have to be monitored during the production, cleaning and sterilization phases of the aseptic process. "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," continued Poupet.

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