Sidel has received Food and Drug Administration (FDA) approval for its Aseptic Combi Predis FMa blow fill seal filler following tests at a dairy customer in North America.
This means that the machine is validated for low acid manufacturing and commercial distribution in the US market.
Guillaume Rolland, sensitive products director at Sidel, said: “We are particularly proud of this FDA acceptance. It confirms our Aseptic Combi Predis design is compliant with the FDA’s current Good Manufacturing Practice (cGMP) requirements. This FDA approval officially qualifies the Sidel aseptic solution with dry preform sterilisation technology to produce and distribute shelf-stable low acid products in PET bottles for the US market. “
The Sidel Aseptic Combi Predis merges dry preform sterilisation with aseptic blowing, filling and sealing functions within a single production enclosure and is said to respect the fundamental concept which underpins state-of-the-art aseptic packaging rules: producing a commercially sterile product, filled in a sterile zone, in a previously sterilised package.