Sidel has secured approval from the Food and Drug Administration (FDA) for its Aseptic Combi Predis FMa blow fill seal filler for low acid product manufacturing.
The new blow fill seal solution is claimed to be the world's first aseptic PET filling equipment with dry preform sterilisation approved by the FDA.
The approval allows the company to use Aseptic Combi Predis FMa PET filler for low acid manufacturing and commercial distribution in the US.
Dover Brook Associates (DBA) is the process authority for the Sidel aseptic filler, which helped to validate the scheduled processes of the product.
Sidel Aseptic Combi Predis combines dry preform sterilisation with aseptic blowing, filling and sealing functions within a single production enclosure.
The package sterilization will be conducted at the preform rather than at the bottle phase for the new blow fill seal filler, which is different from from traditional aseptic technology
According to the company, the stringent validation tests have been carried out on a commercial filler producing aseptic UHT milk that were succeeded.
Sidel sensitive products director Guillaume Rolland said: "It confirms our Aseptic Combi Predis design is compliant with the FDA's current Good Manufacturing Practice (cGMP) requirements.
Sidel aseptic product and platform manager Arnaud Poupet said: "We accumulated more science from these tests performed with DBA. They challenged and validated the process and the technology itself.
"DBA's testing demonstrated that the sterile zone during the blowing process was the critical component, not the blow-moulding zone itself, which was due to the Sidel patented dry-preform sterilisation technology.”
In March this year, Sidel developed a new PET?bottle for Yili liquid milk division’s new Changyi brand.
Chinese dairy producer Yili Group has launched its new range of Changyi yoghurt drinks in the new Sidel PET bottles in the country.
Image: Sidel’s Aseptic Combi Predis FMa blow fill seal filler can be used for low acid product manufacturing. Photo: courtesy of Sidel.