Laboratory Best Practices for the HPP Industry Certified Laboratories, Inc. Bridging Science with Service Since 1926 Steven en Mitchell, ell, Presi sident dent, Certified ified Laboratori ories, es, Inc
Overview ❖ Why HPP? ❖ Products Processed with HPP ❖ Challenge Study ❖ Juice warning Letters ❖ HPP and Low Acid Food ❖ Questions ❖ Microbial Inactivation in Various Food by HPP
Why HPP? ❖ Inactivate pathogens including Listeria, Salmonella, E.coli in various food matrices ❖ Effective on spoilage microorganisms ❖ Enhance shelf life of product ❖ Processes foods with low temperature and preserves product quality (taste, texture, nutritional) compare to traditional pasteurization ❖ Processing the product in final container prevents contamination of food ❖ Additive free preservation technology
Products Processed with HPP Source: http://www.hiperbaric.com/en/applications
Products Processed with HPP Source: http://www.hiperbaric.com/en/applications
Challenge Studies Critica tical l Facto ctors rs to Conside der ❖ Product (pH, aW, fat/oil content, preservatives) ❖ Process ( Pressure, temperature, time, packaging) ❖ Monitoring CCP and Record keeping ❖ Microorganisms – Pressure resistant microorganisms and related to outbreak ❖ How many trials? ❖ Process Deviation and Corrective Action ❖ Safety of product throughout the shelf life
Critical Factors Temperature of different food materials increases quickly during compression and returns back to its initial value upon decompression- Adiabatic atic hea eating Temperature mperature increase rease of v various ous food during ng HPP Substance at 25°C Temperature change per 100 MPa Water, juice, tomato salsa, 2% milk, and other water-like 3 substances Mashed potato 3 Salmon 3.2 Chicken fat 4.5 Beef fat 6.3 Olive oil 8.7 Soy oil 9.1 Reference; IFT, & USFDA. (2014). Kinetics of Microbial Inactivation for Alternative Food Processing Technologies. U.S. Food and Drug Administration
Critical Factors - Process Pres essure, sure, Tempe mperatu rature, re, and d Time ❖ Temperature above or below room temperature increases the inactivation rate of microorganisms during HPP treatment. ❖ 45 to 50°C appear to increase the rate of inactivation of food pathogens and spoilage microbes and thus warrant the development of processes which incorporate a uniform initial food temperature in this range. ❖ Combined pressure (500-700 megapascal (Mpa)) and temperature (90-110°C) have been used to inactivate spore forming bacteria such as Clostridium botulinum . ❖ Important to monitor pressure and product temperature throughout processing ensuring product is held at required Pressure and Temperature for the required time. Reference; IFT, & USFDA. (2014). Kinetics of Microbial Inactivation for Alternative Food Processing Technologies. U.S. Food and Drug Administration
Critical Factor - Microorganism ❖ Determining the most resistant microorganism of public health concern related to the product ❖ Validating the required level of inactivation of the target microorganism ❖ Determine number of trials and replications that would give confidence on the data ❖ Consider to evaluate the recovery of sub lethally injured cells post processing
Standardization of Study Design ➢ The Almond Board ➢ FDA scrutiny of study design ➢ Surrogate development ➢ How does the industry approach the challenge?
Process Deviation and Corrective Action ❖ The critical factors during processing must reach the critical limits defined in HACCP plan ❖ When the critical limits could not be achieved during processing necessary corrective action needs to be taken after determining the severity of the deviation. Exampl ple Complete loss of process pressure before the process is complete could 1. Require reprocessing. 2. A 10% loss of process pressure, for a known time, could be corrected by adding additional holding time on the process at the specified pressure Reference; IFT, & USFDA. (2014). Kinetics of Microbial Inactivation for Alternative Food Processing Technologies . U.S. Food and Drug Administration
Critical Factor – Shelf life Choose appropriate storage temperature which would represent the moderate temperature abuse condition for the product during it’s normal distribution and storage condition ❖ Ensure safety of product through out the shelf life from recovery of injured cells Shelf-life of a food product is commonly defined as the length of time from final product packaging to the point where it is no longer suitable for consumer consumption, either for quality or safety reasons, at a given storage condition.
Warning Letters - HPP & Juices Juice ice HACCP CCP Requi quireme rement: t: Juice HACCP requires to have control measures that will: o consistently produce, at a m a minim nimum, m, a 5 a 5-log og redu duction ction of the pertine rtinent microo roorg rganism sm, o for a period at least as long as the shelf elf life fe of the e produ oduct ct o when stored red under nder norm rmal l an and mo moder erate ate ab abuse use condi nditions tions, to comply with 21 CFR 120.24(a)
Warning Letter -1 Source: https://www.fda.gov/ICECI/EnforcementActions/Warning Letters/2016/ucm530262.htm
Warning Letter – 1 ❖ Juice ce HACC CCP P viola latio tion, n, low acid and high acid juice ce 1. Fail to show 5-log reduction of Clostridium botulinum , the pertinent microorganism for the refrigerated 100% low acid juice product through HPP ( HPP coupled with refrigeration are not validated processes that can reduce the spores of Clostridium botulinum in low-acid juices) 2. No scientific data or evidence that the current critical limits being used by the firm for HPP are sufficient to control the hazards associated with acidic juices Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm530262.htm
Source: ://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm447277.htm
Warning Letter – 2 ❖ Juice ce HACC CCP P viola latio tion, n, low and high h acid juices es 1. Validation study did not identify any pertinent microorganism targeted for various juice products 2. Validation study inadequate to show a 5-log reduction of microorganisms 3. In another validation study, product pH during validation study and actual pH of the product during inspection are different 4. Critical control and critical limit for Clostridium botulinum are not identified in the HACCP plan Source: ://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm447277.htm
Warning Letter – 2 ❖ Juice ce HACC CCP P viola latio tion, n, low and high h acid juices es 5. HACCP plan for “Coconut Water” lists a critical limit of “high pressure processing” that is not adequate to control C. botulinum . HPP processing in the absence of high temperatures does not eliminate Clostridium botulinum spores. The firm’s refrigeration measures are inadequate to control germination of non-proteolytic C. botulinum spores and subsequent toxin formation. 6. The firm did not monitor sanitary conditions for protection of food, food packaging material, and food contact surfaces from adulteration with contaminants, or the proper labeling, storage and use of toxic compounds. Source : www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm447277.htm
Warning Letter – 3
Warning Letter – 3 Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm564197.htm
Warning Letter – 3 ❖ Juice ce HACC CCP P viola latio tion n for low and high acid juices ces 1. Fail to show HPP can achieve 5 log reduction of C. botulinum in refrigerated low acid juices 2. the 3 validation studies to cover multiple high acid juice products with varying compositions based on pH equal or less than the juice(s) studied. “However, no scientific support was given to substantiate the conclusion” Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm564197.htm
Warning Letter – 3 3. For each validation study, only one HPP process run with multiple samples was evaluated and there was no true replication of the HPP process to understand process variability 4. Process deviation (Did not reach the desired pressure) was identified however no corrective action was taken. 5. Lack CCP monitoring record Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm564197.htm
HPP and Spore Inactivation In Low Acid Food ❖ Spores (proteolytic and non- proteolytic C. botulinum) in low acid food are big concern as they y can germin inate te, grow and produce ce fatal toxi xins ❖ Development of Low Acid Shelf stable food by HPP is a challenge ❖ Need to identify the most pressure resistant strain of C. botulinum and worst case product ❖ Optimize HPP processing condition in combination with other hurdle technology to develop shelf stable low acid product
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