SIDEL announces FDA approval.
The Sidel Aseptic blow fill seal solution is the world's first aseptic PET filling equipment with dry preform sterilisation approved by FDA. It has recently received Food and Drug Administration (FDA) approval for its Aseptic Combi Predis(tm) 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. "We are particularly proud of this FDA acceptance", explains Guillaume Rolland, Sensitive Products Director at Sidel. "It confirms our Aseptic Combi Predis design is compliant with the FDA's current Good Manufacturing Practice (cGMP) requirements." 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 US market.
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.
Sidel's reputation is built on a long history and experience with sensitive products: 40 years in aseptic beverages and dairy bottling solutions, more than 35 years in PET packaging and 50 years in blowing. Sidel was a pioneer in preform sterilization, allowing the first production of PET bottles for UHT milk on a Sidel aseptic Combi with this dry preform sterilization technology in 2002. With its proven and patented solution, Sidel Predis, Sidel continues to enjoy a leading position in sensitive beverages and liquid dairy production technology. Sales of Sidel Predis have grown steadily as companies throughout the world have recognized the benefits it offers: safety and simplicity, cost-effectiveness, no water and use of very few chemicals (offering significant environmental advantages).