Laboratory Best Practices for the HPP Industry Certified - - PowerPoint PPT Presentation

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Steven en Mitchell, ell, Presi sident dent, Certified ified Laboratori

• ries,

es, 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?

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

• us food during

ng 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 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:

• consistently produce, at a m

a minim nimum, m, a 5 a 5-log

• g redu

duction ction of the pertine rtinent microo roorg rganism sm,

• for a period at least as long as the shelf

elf life fe of the e produ

• duct

ct

• 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

• f 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

Sample Selection (based on critical parameters: pH, aw, brix etc.) Processing parameter selection Pertinent microorganism s 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 t and Poultr ultry y Prod

• ducts

ucts

❖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

Jui uices ces

http://ucanr.edu/datastoreFiles/608-604.pdf Source: http://www.hiperbaric.com http://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

Sp Spor

• re

e For

• rmi

ming ng Ba Bacter teria ia

Source: http://onlinelibrary.wiley.com/doi/10.1111/j.1541-4337.2007.00021.x/pdf

HPP and Spore Inactivation

HPP an and Temper mperat ature ure

Source: http://onlinelibrary.wiley.com/doi/10.1111/j.1541-4337.2007.00021.x/pdf

References

Crawfo ford Y.J., ., Murano no E.A., ., Olson D.G., ., Shenoy y K. (1996) J. Food Prot., 59 59, 711-715. Hayak akaw awa a I., Kanno no T., Yoshi hiyai yaina na K., Fujio Y. (1994) J. Food Sci., 59 59, 164-167. Knorr rr D. (1995) 5) In: High h Pressure ure Proc

• cess

essing ng of Food

• ds (D.A.

. Ledward ard, D.E. . Johnst nston,

• n, R.G.

. Earnsh nshaw aw, A.P.M .M. . Hasting ng, Eds.), .), Nottingham ham Univers versity y Pres ess, Notting ngham ham, p. . 123. Knorr rr D. (1995) In: New Methods of Food Preservation (G.W. Gould, Ed.), Blackie Academic and Professional, New York, p. 159. Hoover er D.G. . (1993) Food Technol., 47 47(6), 150-155. Gould G.W. . and Sale A.J.H. .H. (1970) J. Gen. Microbiol., 60 60, 335-346. Sale e A.J.H., H., Goul uld G.W., Hamilton n W.A. (1970) J. Gen. Microbiol., 60 60, 323-334. Zhu and others (2008) Int J Food Microbiol 126(1–2):86–92 Hayman an M., Baxter er I., Orior

• rdan

an P.J., ., Stewart art C.M. (2004) J. Food Prot., 67 67(8), 1709-1718. Hoover D.G., Metrick C., Papineau A.M., Farkas D.F., Knorr D. (1989) Food technology, 43, 99-107