The validation means the technology can be used for low acid manufacturing and commercial distribution in the US.
Low acid products
According to Guillame Rolland, sensitive products director, Sidel, the FDA approval qualifies the aseptic filler with dry preform sterilization technology to produce and distribute shelf-stable low acid products in PET bottles for the US market.
The Process Authority for the Sidel aseptic filler was Dover Brook Associates (DBA).
Regulatory approval means the technology is 100% safe for packaging UHT milk, soy milk, coconut water, or teas in PET bottles, sold through the ambient chain market in the US and the rest of the world.
DBA conducted a review of the design, critical factors, and sterile zone boundaries. The validation tests were performed on a commercial filler producing aseptic UHT milk, and all the tests were successfully passed.
“We accumulated more science from these tests performed with DBA. They challenged and validated the process and the technology itself,” added Arnaud Poupet, aseptic product and platform manager, Sidel.
“DBA’s testing demonstrated 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 sterilisation technology.”
He said it partnered with one of the major dairy producers in North America who invested in the technology to introduce UHT liquid dairy products in PET bottles.