PETpla.net Insider 04 / 2018

BOTTLING / FILLING PET planet Insider Vol. 19 No. 04/18 www.petpla.net 35 FDA approval of Sidel’s Aseptic Combi Predis blow fill seal filler for low acid product manufacturing in the U.S. UHT liquid dairy products in PET Sidel has received Food and 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 PET filler is validated for low acid manu- facturing and commercial distribution in the United States market. The Sidel Aseptic blow fill seal solution is claimed to be the world’s first aseptic PET filling equipment with dry preform sterilisation approved by FDA. The FDA approval officially quali- fies the Sidel aseptic solution with dry preform sterilisation technology to produce and distribute shelf-stable low acid products in PET bottles for the U.S. market. The Process Authority for the Sidel aseptic filler was Dover Brook Associates (DBA). DBA applied their 30 years of professional experience in ster- ile processes to validate the scheduled processes of the Aseptic Combi Predis. Using a scientific-based approach of specific tests and acceptance criteria, DBA was able to prove that the sched- uled processes were in compliance with the predicate rules and expectations of the FDA so that the equipment could produce a commercially sterile low acid product. The Sidel patented technology is said to be safe for the packaging of UHT milk, soymilk, coconut water, or teas in PET bottles, sold through the am- bient chain market in the US and the rest of the world. Merging dry preform sterilisation with aseptic functions The Sidel Aseptic Combi Predis merges dry preform sterilisation with aseptic blowing, filling and sealing functions within a single production enclosure and respects the funda- mental 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. It dif- fers from traditional aseptic technol- ogy because the package sterilisation takes place at the preform rather than at the bottle phase. DBA 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 suc- cessfully passed. “We accumulated more science from these tests per- formed with DBA. They challenged and validated the process and the technology itself”, explains Arnaud Poupet, Aseptic Product and Platform Manager at Sidel. DBA concluded that the minimised sterile zone provided a safe and successful aseptic process that produced a commercially sterile, hermetically sealed bottle. “DBA’s test- ing demonstrated that the sterile zone during the blowing process was the critical component, not the blow-mould- ing zone itself, which was due to the Sidel patented dry-preform sterilisation technology”, comments Poupet. The scheduled processes require minimal critical factors, which have to be moni- tored during the production, cleaning and sterilisation phases of the aseptic process. The critical parameters are continuously monitored to ensure full production sterility, beverage integrity and food safety. “Our best warranty for food safety is simplicity, because a line with a small sterile zone and mini- mal critical factors is managed more safely, easily and effectively,” continues Poupet. “We partnered with one of the major dairy producers in North America who was confident of the safety and efficiency of the Aseptic Combi Predis. He invested in the solu- tion to introduce new UHT liquid dairy products in PET bottles. Under the coordination of DBA, we went through a rigorous FDA qualification pro- cess at the FDA registered customer site”, explains Poupet. The Aseptic Combi Predis approved by the FDA is very similar to the existing machines installed for aseptic production in cus- tomers’ plants worldwide. www.sidel.com