Validation Considerations for New Technologies:

Transcription

1 Validation Considerations for New Technologies: A Practitioner s Perspective 2012 GMA Science Forum

2 Hormel Foods Originate, don t imitate George A. Hormel

3 So, What s New? Marketing just heard about this new great technology They want it tomorrow They heard that it needs to be validated So can you just write something up that takes care of that?

4 What Does It Take? How does a company validate that a new technology will deliver safe food? Do you understand what it is that you think you know? Do you know enough to understand what it is that you need to know?

5 1. Know Your Products How is the product stored? Fresh, frozen, refrigerated, shelf stable? What are the product key characteristics? ph, water activity, moisture, formulation, chemical inhibitors (natural or added), modified atmosphere?

6 1. Know Your Products Stability What is the normal temperature range for the product? What happens if the temperature is abused? What happens if stored at different conditions?

7 2. Know your equipment. What is it expected to do? Rated capacity? Batch process, or continuous? How much variation is there? Machine effects mixing, temperature, speed, uniformity Product effects viscosity, particulates, etc.

8 3. Know your process. Will all product get the same process? What temperatures or other lethal agents are required? Will all product get at least the minimum required process? Are the conditions in the product and the equipment reasonably uniform?

9 3. Know your process. What can go wrong? How will you know? Three important parameters: Precision Accuracy Reliability

10 4. Know your enemy. What microorganisms are present? What microorganisms need to be addressed? Vegetative cells only? Spores?

11 4. Know your enemy. Pathogen of consequence Most resistant spoilage organism Can change with ph, temperature range, storage conditions, water activity, process dynamics

12 Where Do We Start? All four parts are interrelated, need to look at them all together. Answers in one area may change the answers in another. If an item changes, review previous assessments, go through list again.

13 Validation What do we use to do to actually validate the process? Known testing protocols Literature, test results Challenge studies

14 Known Testing Protocols Heating Hot fill and hold Aseptic fill Heating after fill (pasteurizer, retort) Chemical inhibitors Sorbate and benzoate well known Fermentation, salt, nitrite, pickling Other inhibitors less certain?

15 Known Testing Protocols What lethality is needed? How is it documented that it is there?

16 Literature and test results Literature searches Published testing by others What assumptions are being made? Do the results really cover your situation? May require additional testing to prove

17 Challenge Studies Specific testing that challenges a system directly with microorganisms Must consider all of the previous knowledge areas (product, equipment, process, microorganisms of consequence) Ranges and extremes worst case? Commonly uses surrogate microorganism which one?

18 Needs Expertise Testing capability In-house Trade organizations Consortiums Manufacturers? Consultants Your know-it-all brother-in-law

19 Regulatory Issues Regulatory personnel are not your friends Protect the public, not build your business In the right situations, can be helpful in preventing serious oversights and erroneous assumptions

20 So Do you really understand what it is that you think you know?

21 Examples High pressure - HPP Primarily used for pasteurization Has been validated for use on fruit and vegetable products Used to reduce potential post process contamination in sliced meat products Testing showed that Listeria monocytogenes was most resistant pathogen

22 What is HPP? Isostatic, hydrostatic pressure Equal but uniform No shear force

23 Microbial Inactivation Key Factors in HPP Pressure Compression time Time at Pressure Decompression time Product Composition water activity ph Temperature

24 Commercial HPP systems Vessel layout horizontal Automatic loading / unloading Wave 6000 / 55 L Wave 6000 / 135 L Wave 6000 / 300 L Wave 6000 / 420 L Maximum pressure 600 MPa = 87K psig

25 Application: Produce Food safety assurance Stabilizes enzyme activity Preserves and enhances: Natural flavor Color Texture Other quality attributes Extends shelf-life

26 Application: RTE Meats Post-process intervention Fully cooked Extended shelf life Food safety assurance

27 Examples High pressure Commercial Sterility Clostridium botulinum most resistant organism of concern Initial evidence that high pressure made C. botulinum more resistant later, not true Synergistic effects uncertain, FDA process filing based on adiabatic heating only

28 Examples Microwave processing - pasteurization Used for pasteurization of various products, including ready to eat refrigerated meals Can heat at atmospheric pressure? Commercial lines operating in Europe Used as a method of heating only no synergistic effects accounted for Measurement of microwave energy delivered to each package not a trivial problem

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30 Cold Spots

31 Cold Spots

32 Examples Microwave processing - shelf stable Can be used to produce commercially sterile product pressurized system Commercial lines operating in Europe product 100% incubated and inspected FDA filed processes in USA for prototype equipment Heat only used for lethality Energy difficult to measure and prove

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34 Cold Spots

35 Cold Spot

36 Microwave Energy

37 Other Technologies Irradiation Ohmic heating Pulsed Electric Field Pulsed High Intensity Light Ultraviolet Light Radio Frequency Chemical Genetic?

38 Thank you!