Case Studies

Validation of aseptic fillers intended for the production of low-acid, shelf-stable products is a core requirement of the FDA’s low-acid canned food (LACF) regulations (21CFR113 and 108.35). Microbiological challenges of the aseptic zone and packaging material sterilization cycles are important components of the validation process. These challenges are often conducted at the production site using non-pathogenic surrogate organisms that mimic the resistance of the pertinent target pathogen. This presentation will provide a brief history of the use of such surrogates for the validation of low-acid aseptic fillers along with the approach we have used to qualify the surrogates as adequate for the intended technology.”