CHICAGO— Acidified products have an outstanding safety record; however, recent outbreaks have shown that a number of pathogens can survive for extended periods. Silliker Food Science Center, a Merieux NutriSciences company, now offers process authority services to support manufacturers of acidified foods.
The U.S. Food and Drug Administration (FDA) now requires manufacturers of these products—defined as a low acid food with added acid or acid food(s) to obtain a pH of 4.6 or below, and a water activity greater than 0.85—to register their facility and file scheduled processes for their products with the agency in accordance with 21 CFR 108 and 114. Recently, the FDA issued a draft guidance outlining proposed changes to procedures utilized by acidified food manufacturers for submitting process information.
Support services provided by the research center include assistance in filing required FDA forms, process consultation, Process Authority Letters, and scientific studies to verify process performance. Personal consultation on filing the required processing forms is offered upon request. Process consultation can be conducted via telephone or during an on-site visit. The Food Science Center is qualified to issue a Process Authority Letter, which assesses submitted production process and formulation details, supplemented in some cases with literature review and other scientific substantiation.
“Our key scientists have extensive educational backgrounds, personal experience, credentials as process control experts and numerous successful scientific studies in this field," said Wendy McMahon, general manager at the Food Science Center. “We’ve seen a large increase in the need for process authority services from this industry segment."
For the acidified foods requiring a scientific study, such as a challenge or preservative efficacy study, to verify log reduction or organism inactivation, the Merieux NutriSciences team have the needed expertise and tools at their fingertips. The facility houses a biosafety level 2 pilot plant, a large culture collection and the personnel have years of experience in running challenge studies in accordance with NACMCF guidelines.