Press release — 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 manufacturing and commercial distribution in the United States market. The blow fill seal solution is the world’s first aseptic PET filling equipment with dry preform sterilisation approved by FDA.
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 U.S. market.
Independent evaluation from experienced organisation
The Process Authority for the Sidel aseptic filler was Dover Brook Associates (DBA). DBA applied their 30 years of professional experience in sterile 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 scheduled 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 successful completion of this extensive and exhaustive evaluation process confirms the performance of the other 100 Combi Predis lines in operation worldwide. 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 regulatory acceptance demonstrates how the Sidel patented technology is 100% safe for the packaging of UHT milk, soymilk, coconut water, or teas in PET bottles, sold through the ambient chain market in the US and the rest of the world.
A scientific approach for regulatory validation
The Sidel Aseptic Combi Predis merges dry preform sterilisation with aseptic blowing, filling and sealing functions within a single production enclosure and respects 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. It differs from traditional aseptic technology 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 successfully passed.
The Aseptic Combi Predis approved by the FDA is very similar to the existing machines installed for aseptic production in customers’ plants worldwide.