Sidel gained the FDA’s approval after successfully completing test runs at one its North American dairy customer’s facilities. 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.
“This FDA approval officially 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,” Guillaume Rolland, sensitive products director at Sidel, said.
It confirms also confirms the Aseptic Combi Predis design is compliant with the FDA’s current Good Manufacturing Practice (cGMP) requirements, Rolland added.
According to GMP requirements, all manufacturers and processors must register their low-acid aseptic filling systems with the FDA within 10 days of first using the packaging or processing machine.
Approval process
The Sidel patented aseptic technology is safe for the packaging of UHT milk, soy milk, coconut milk, or teas in PET bottles, according to the company.
The Process Authority for the Sidel aseptic filler, Dover Brook Associates, used a scientific-based approach of specific tests and acceptance criteria to prove and validate that the scheduled processes were in compliance with the rules and expectations of the FDA so that the equipment could produce a commercially sterile low acid product.
“We accumulated more science from these tests performed with DBA. They challenged and validated the process and the technology itself,” Arnaud Poupet, aseptic product and platform manager at Sidel, said.
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-moulding zone itself, which was due to the Sidel patented dry-preform sterilization technology,” Poupet added.
“The successful completion of this extensive and exhaustive evaluation process confirms the performance of the other 100 Combi Predis lines in operation worldwide,” the company said in a statement.