laboratory best practices for the hpp industry · laboratory best practices for the hpp industry...
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Certified Laboratories, Inc.Bridging Science with Service Since 1926
Steven Mitchell, President,Certified Laboratories, Inc
Laboratory Best Practices for the HPP Industry
❖ Why HPP?
❖ Products Processed with HPP
❖ Challenge Study
❖ Juice warning Letters
❖ HPP and Low Acid Food
❖ Questions
❖ Microbial Inactivation in Various Food by HPP
Overview
❖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
Why HPP?
Challenge Studies
Critical Factors to Consider
❖ 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 heating
Temperature increase of various food during HPP
Reference; IFT, & USFDA. (2014). Kinetics of Microbial Inactivation for Alternative Food Processing Technologies. U.S. Food and Drug Administration
Substance at 25°C Temperature change per 100 MPa
Water, juice, tomato salsa, 2% milk, and other water-like
substances 3
Mashed potato 3
Salmon 3.2
Chicken fat 4.5
Beef fat 6.3
Olive oil 8.7
Soy oil 9.1
Critical Factors - Process
Pressure, Temperature, and 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.
ExampleComplete 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 HACCP Requirement:
Juice HACCP requires to have control measures that will:
oconsistently produce, at a minimum, a 5-log reduction of the
pertinent microorganism,
ofor a period at least as long as the shelf life of the product
owhen stored under normal and moderate abuse conditions,
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 HACCP violation, low acid and high acid juice
1. Fail to show 5-log reduction of Clostridiumbotulinum, 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 HACCP violation, low and high acid juices
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 Clostridiumbotulinum are not identified in the HACCP plan Source: ://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm447277.htm
Warning Letter – 2
❖Juice HACCP violation, low and high acid juices
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
Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm564197.htm
Warning Letter – 3
❖Juice HACCP violation for low and high acid juices
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 can germinate, grow and produce fatal toxins
❖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
Sample Selection
(based on critical parameters: pH, aw, brix etc.)
Processing parameter selection
Pertinent microorganisms determination
Sample Receipt- Hold at 5±1°C
until study initiation
Culture Growth - 2 consecutive
transfers to broth then
enumerate for level using non-selective agar
Inoculation -Inoculate the
product for the target pathogen at 10,000,000
(7.0-log) CFU/g
Ship Samples -Ship next day to HPP Processor
under refrigeration
HPP processing (one trial)
Samples Processed -Shipped to
Certified for next day under
refrigeration
Day 1 Enumeration - X
replicates of traveling control
samples and inoculated treated
samples enumerated for
target pathogen (on selective media to account for injured
cells)
Store Remaining Samples at
5±1°C
Enumerate for Remaining
Time Points
(on selective media to
account for injured cells)
Day 0 Enumeration -Enumerate X replicates for
target pathogen for level
immediately after inoculation
Certified Laboratories - HPP Validation Protocol
Questions
1. Do we know the resistant microorganism to validate various HPP treated food products?
2. For HPP validation how many HPP process run needs to be done? Will 2 run suffice the requirement?
3. Is one validation study sufficient to cover other similar products or do we need to validate each product that is produced by HPP ?
4. Does the Process Authority need to review the critical parameters record for HPP validation study when work through HPP tolling facility for various clients?
Questions
Microbial Inactivation in Various Food by HPP
Meat and Poultry Products❖RTE meats treated at 600 MPa, 20°C for 180 sec--- gave a 4 log reduction in Listeria monocytogenes , enhanced refrigerated shelf- life, and sensory quality (Hayman et al, 2004).
Source: http://www.hiperbaric.com
Microbial Inactivation in Various Food by HPP
Source: http://www.hiperbaric.com
Meat and Poultry Products – Shelf life Extension
Microbial Inactivation in Various Food by HPP
Juices
http://ucanr.edu/datastoreFiles/608-604.pdf
Source: http://www.hiperbaric.comhttp://www.thenfl.com/wp-content/uploads/HPP-Poster-IAFP-2015-7-23-
2015.pdf
Microbial Inactivation in Various Food by HPP
Cheese
http://jfoodprotection.org/doi/pdf/10.4315/0362-028X-
67.8.1671?code=fopr-site
Guacamole
Source: http://www.hiperbaric.com
HPP and Spore Inactivation
Spore Forming Bacteria
Source: http://onlinelibrary.wiley.com/doi/10.1111/j.1541-4337.2007.00021.x/pdf
HPP and Spore Inactivation
HPP and Temperature
Source: http://onlinelibrary.wiley.com/doi/10.1111/j.1541-4337.2007.00021.x/pdf
References
Crawford Y.J., Murano E.A., Olson D.G., Shenoy K. (1996) J. Food Prot., 59, 711-715.Hayakawa I., Kanno T., Yoshiyaina K., Fujio Y. (1994) J. Food Sci., 59, 164-167.Knorr D. (1995) In: High Pressure Processing of Foods (D.A. Ledward, D.E. Johnston, R.G. Earnshaw, A.P.M. Hasting, Eds.), Nottingham University Press, Nottingham, p. 123.Knorr D. (1995) In: New Methods of Food Preservation (G.W. Gould, Ed.), Blackie Academic and Professional, New York, p. 159.Hoover D.G. (1993) Food Technol., 47(6), 150-155.Gould G.W. and Sale A.J.H. (1970) J. Gen. Microbiol., 60, 335-346.Sale A.J.H., Gould G.W., Hamilton W.A. (1970) J. Gen. Microbiol., 60, 323-334.Zhu and others (2008) Int J Food Microbiol 126(1–2):86–92Hayman M., Baxter I., Oriordan P.J., Stewart C.M. (2004) J. Food Prot., 67(8), 1709-1718.Hoover D.G., Metrick C., Papineau A.M., Farkas D.F., Knorr D. (1989) Food technology, 43, 99-107