The Eurofins team of process authorities routinely provides expert guidance to food manufacturers to prepare microbiologically safe products. The role of the process authority is multi-faceted, including but not limited to:
In this service, we encounter many questions that span across a variety of food products and manufacturing processes. Here we list our most common questions and answers.
Martha Kimber: "It might be possible, but you will need data to support what you are hoping to achieve. The first step would be to clearly define your performance criteria for success. For example, is the preservative intended to:
In some cases, we can refer to the scientific literature and do pathogen modeling to predict success, however, the gold standard would be to perform inoculated challenge studies with the new product formulation containing preservatives, in order to determine if the performance criteria are met. Notably, the challenge study design and execution would differ depending upon the applicable regulations and performance criteria."
Martha Kimber: "Navigating the regulatory classification of acidified vs. acid foods can be murky at times. Our team can perform an assessment to determine if a product may be categorized as an acid or an acidified food by closely examining the composition and pH of individual ingredients and the finished product formulation as a whole. Based on our assessment, we can prepare a process authority opinion letter. Acidified foods are required to be filed with the FDA per 21CFR114. Other products that are naturally acidic, refrigerated, carbonated, fermented, etc., may be exempt from 21CFR114 (but will still be covered by 21CFR117)."
Shirin Abd: "Yes, if the product has a pH >4.6 and is held at ambient conditions, then you will need to file with the FDA under the low acid canned foods regulations (LACF; 21CFR113)."
Martha Kimber: "Absolutely! To start, we can assist by reviewing each product formulation and by grouping similar formulations together. We can then select representative formulations from each grouping for subsequent challenge studies which will be designed based upon guidance from the FDA and applicable scientific literature. Finally, we can provide process authority letters based upon the grouping and challenge study results, and even provide filing assistance, if required."
Shirin Abd: "Yes, our laboratory has the capability to inoculate the juice product(s) with pertinent pathogenic organisms per Juice HACCP (21 CFR 120), HPP-treat the samples, and then test the samples over the desired refrigerated shelf life. The data generated from the studies will allow you to determine if the HPP treatment is adequate to achieve and maintain appropriate log reductions of the target organisms, and can be used in support of your food safety plan."
Martha Kimber: "Not necessarily, but you need to make sure that you are addressing the risk of post-process contamination by acid tolerant pathogens and spoilage organisms which may be introduced after cooling, during filling, or from the non-sterile packaging. We can recommend conservative hot fill processes, or even cold-fill-hold processes, based upon data available in the literature and/or laboratory data."
Shirin Abd: "Of course! We will start by gathering info about ingredients, finished product specifications, processing capabilities, packaging, desired shelf life, etc. We will then provide a conservative process recommendations based on scientific literature. Or, if you would like to use a non-standard process, we can perform process validation studies."
Martha Kimber: "Absolutely. We can review processing records, batching records, finished product test results, etc. We will then provide a process deviation letter that either recommend additional testing, destruction of the affected lot(s), rework, or we might state that the affected lot is safe for release."
Shirin Abd: "Yes, process validation is one of our core services. The approach of the study will depend upon the product, how it is processed, and the type of equipment that you are using. In some cases, we can do a laboratory benchtop study with the actual target pathogen(s). In other cases, we might need to go onsite and run product that is inoculated with a non-pathogenic surrogate through your actual processing equipment. The conclusion of both study types is to better understand the efficacy of your CCP/kill step for your pet food product."
If you have a question for a process authority that is not answered here, let us know.