SCIENTIFIC PARAMETERS FOR ESTABLISHING THE …phariyadi.staff.ipb.ac.id/files/2018/05/MPTP-2018-Ekuivalensi-P... · Atau, satu perlakuan sajasebetulnya cukup untuk ... sekarang banyakpula

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Hariyadi, P. 2018. Scientific Parameters for Establishing the Equivalence of Pasteurization Processes. ITP506

phariyadi.staff.ipb.ac.id

SCIENTIFIC PARAMETERS FOR ESTABLISHING

THE EQUIVALENCE OF PASTEURIZATION PROCESSES

Purwiyatno Hariyadiphariyadi.staff.ipb.ac.id

[email protected]


Kondisi (pemanasan) dan tujuan pasteurisasi dari beberapa produk pangan … (1)

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Kondisi (pemanasan) dan tujuan pasteurisasi dari beberapa produk pangan … (2)


Kondisi (pemanasan) pasteurisasi susu & produk-produk susu*).

*) IDFA, Pasteurization: Definition and Methods. ( http://www.idfa.org/files/249_Pasteurization%20Definition%20and%20Methods.pdf)


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E


Kondisi (pemanasan) pasteurisasi susu & produk-produk susu*).

Ekivalensi? Nilai Pasteurisasi (Pasterurization value) = Pv

.

10 .

10

T = Suhu produk selama proses pasteurisasiTR = Suhu Acuan PasteurisasiZ = Nilai Z untuk mikroba (pathogen) target


SCIENTIFIC PARAMETERS FOR ESTABLISHING THE EQUIVALENCE OF PASTEURIZATION PROCESSES

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Alternative-Emerging Food Processing Technologies (FDA/IFT 2000)http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm100158.htm

• Microwave and Radio Frequency • Ohmic and Inductive Heating • High Pressure Processing • Pulsed Electric Field • High Voltage Arc Discharge • Pulsed Light • Ultraviolet Light • Ultrasound • X-Rays


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Equivalence of alternative technologies

Questions of Interest

Process Description?

Mechanism of Activation?

Critical Factors and Quantification?

Process deviations?

Organizms of concern?

Indicator organizms ?

Main reseacrh need ?

Generator(Oscilator)

+/-

+/-

FoodMaterial

H H

H H

O

O

-

++++

-“Change of Orientation

Polarization”

++

Ionicdisplacement








Process deviations?




Generator(Oscilator)

+/-

+/-

FoodMaterial

Internal Heating- keyword: Heating


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Process deviations?




Technology

Microwave Ohmic Heating

Well described Well described

Well described Well described

Well describedHard to predict cold zone

Well describedHard to predict cold zone

As in conventional thermal processing






Prediction of cold zoneand Uniformity of heating

Prediction of cold zone








Process deviations?




Technology of High Hydrostatic Pressure

• High Pressure can kill microorganisms by interrupting with their cellular function without the use of heat that can damage the taste, texture, and nutritional value of the food.

~87000 psi~36000 psi


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Process deviations?





Well described

Well described

Well describedProposed Models

Well described

Identified

Suggested

Validation kineticsInfluence of synergistic processing conditions




• Incativate food pathogens (salmonella and E.coli0157:H7)

• Preserve the fruit juice's fresh, natural characteristics.

• HHP of 80,000 psi for 30 seconds a 3‐5 log reduction of all of the pathogens of concern in fresh juice


Fruit Juice treated by HHP


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• Another example of food safety is the destruction of Vibrio bacteria in raw oysters without destroying the raw feel and taste of the oyster.

• A pressure of 200 to 300 MPa for 5 to 15 minutes at 25C inactivated : ∙ Vibrio parahaemolyticus ATCC 17803, ∙ Vibrio vulnificus ATCC 27562, ∙ Vibrio choleare ATCC 14035, ∙ Vibrio choleare non‐O:1 ATCC 14547, ∙ Vibrio hollisae ATCC 33564∙ Vibrio mimicus ATCC 33653

("D. Berlin, D. Herson, D. Hicks, and D. Hoover; Applied and Environmental Microbiology, June 1999“)

Oyster treated by HHP



Destroys the vibrio in shellfishDetaches the meat from the shell



Oyster treated by HHP


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Figure. Change in inactivation of Zygosaccharomyces bailii with pressure.

Note that 345 MPa = 50,000 psi. (Enrique Palou, GRA, BSysE Dept., WSU)

Effect of pressure is very similar to the effect of temperature in thermal processes

High hydrostatic pressure



Thermally-assisted high-pressure lifts quality of shelf-stable foods

Process Variables for Optimum Quality

Tempera-ture

Pressure Products

90°C 700 MPaMain meal entrees, meats, pasta dishes, most vegetables, sauces, cheese, soups, stews, flavored milk drinks

80°C 830 MPa Whole potatoes, most vegetables

70°C 1,000 MPa All potato products, all vegetables, seafood

60°C 1,240 MPa Eggs, milk

Source: Richard S. Meyer, PhD, Washington Farms, Inc.



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Two things must be done.

1. First, develop the kinetic information necessary to file a petition with the FDA and USDA. To do that, we have to select the most heat and pressure-resistant strain of Clostridium botulinum.

2. Second, we need commercial-size, inexpensive high-pressure vessels.

What's needed to commercialize UHP for sterilizing shelf-stable products?





Pressure(Mpa)




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NACMCF definition of ‘pasteurization’ :

Any process, treatment, or combination thereof, that is applied to food to reduce the most resistant microorganism(s) of public health significance to a level that is not likely to present a public health risk under normal conditions of distribution and storage.

Suatu proses, perlakuan (atau kombinasi perlakuan) yang diaplikasikanpada produk pangan untuk mengurangi jumlah mikroba yang paling tahan (resistant) terhadap perlakuan (atau kombinasi perlakuan) yang diberikan dan berpotensi nyata mengancam kesehatan publik sampaijumlah akhir yang tidak lagi memberikan risiko terhadap kesehatanpublik jika produk disimpan dan didistribusikan pada kondisi normal


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NACMCF recommends that:

• Regulatory agencies establish a Food Safety Objective (FSO) and/or a performance standardfor food/pathogen combinations that can be used as the basis for judging equivalency when a proposed process is evaluated as an alternative to traditional pasteurization.



1. ”Suatu perlakukan (atau kombinasi perlakuan) .... ”

• Pasteurisasi bisa mencapai dua tujuan sekaligus, yaitu tujuan untuk memberikan perlindunganterhadap kesehatan publik dan tujuan memperpanjang umur simpan produk pangan. Namundemikian, pemilihan “suatu perlakukan (atau kombinasi perlakuan)” hendaknya didasarkan padapencapaian tujuan utama yaitu untuk memberikan perlindungan terhadap kesehatan publik (menjamin keamanan pangan).

• Tujuan pasteurisasi dapat dicapai dengan kombinasi perlakukan terutama jika satu perlakuan saja tidak cukup untuk mencapai tujuan utamanya. Atau, satu perlakuan saja sebetulnya cukup untukmencapai tujuan utamanya tetapi akan menyebabkan perubahan mutu produk yang terlalu tinggiatau tidak dikehendaki.

• Secara tradisional proses perlakuan pasteurisasi adalah dengan panas sebagaimana yang banyakdiaplikasikan – terutama untuk pasteurisasi susu dan telur cair.

• Prinsip yang sama terutama yang terkait dengan model inaktiviasi termal mikroba, bisa digunakansebagai landasan merancang proses pasteurisasi dengan perlakuan lain tetapi masih berbasiskan pada termal yaitu perlakuan pasteurisasi dengan gelombang mikro (microwave), pemanasan ohmic (ohmic heating), maupun penggunaan uap panas (untuk pasteurisasi permukaan pangan padat).

• Untuk perlakuan selain panas, misalnya perlakuan tekanan tinggi (high pressure), radiasi UV dan iradiasi diperlukan model inaktivasi mikroba yang sesuai dan hal ini berbeda dengan model inaktivasi termal mikroba.


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2. “…yang diaplikasikan pada produk pangan untuk mengurangi jumlah mikroba (atau

mikroba‐mikroba) …”

• Pengertian “mengurangi jumlah mikroba” pada definisi ini tidak hanya berarti menginaktivasi mikroba (bisa dengan panas, tekanan dan lain‐lain) tetapi juga dapat berarti mengurangi jumlah mikroba dengam cara filtrasi.

• Pada prinsipnya pengurangan jumlah secara total (absolut) tidak dapat dicapai karena secara mekanisme inaktivasi mikroba (juga secara peluang statistik), selalu ada peluangsatu mikroba yang tetap bertahan dalam produk, walaupun peluangnya sangat kecil(misalnya dalam 1 produk diantara 1,000,000 produk yang diproduksi), sehinggakeberadaan mikroba dalam produk ini tidak lagi mengancam kesehatan publik.

• Pada awalnya proses pasteurisasi ini dikembangkan dan diaplikasikan untuk produk pangan cair (minuman, misalnya pasteurisasi susu, sari buah, telur cair, dll), tetapisekarang banyak pula diaplikasikan pada produk pangan padat (misalnya sosis, hot dogs). Untuk produk pangan cair proses pasteurisasi harus dipastikan supaya setiappartikel produk menerima tingkat perlakuan yang cukup. Untuk produk pangan padat harus dipastikan bahwa setiap permukaan produk menerima tingkat perlakuan yang cukup.



3. “…(i) paling tahan (resistant) terhadap perlakuan (atau kombinasi perlakuan) yang

diberikan dan (ii) berpotensi nyata mengancam kesehatan publik …”

• Sebagaimana dinyatakan di atas, tujuan utama proses pasteurisasi adalah untukmemberikan perlindungan kesehatan publik. Karena alasan itu, maka mikroba target (microrganisms of concern) untuk proses pasteurisasi umumnya dikembangkanberdasarkan pada data epidemiologi yang berkaitan dengan produk pangan yang akandipasteurisasi.

• Mikroba target ini bisa mencakup bakteri, virus, dan parasit penyebab penyakitataupun pembentuk racun.

• Identifikasi mikroba (atau mikroba‐mikroba) target ini sangat dipengaruhi oleh sifatintrinsik mikroba (terutama sifat ketahanan dan jumlah awal mikroba) dan sifat produk pangan yang mempengaruhi pertumbuhan dan ketahanan mikroba (pH, aw, komposisigizi, dan lain‐lain).

• Pada umumnya, proses pasteurisasi dirancang untuk menginaktivasi (membunuh) ataumengurangi sel vegetatif patogen target, termasuk sel vegetatif pathogen pembentukspora. Namun demikian, pada kasus khusus tertentu proses pasteurisasi dapatdirancang untuk menginaktivasi spora misalnya spora Clostridium botulinum non‐proteolitik (psychrotrophic) pada daging kepiting atau rajungan (crabmeat).


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4. “…jumlah akhir yang tidak lagi memberikan risiko terhadap kesehatan publik …”

• Risiko kesehatan publik merupakan fungsi dari jenis, jumlah awal dan kemampuan produk pangan untuk mempengaruhi pertumbuhan atau ketahanan patogen, serta kerentanan konsumen yang mengkonsumsinya.

• Keberadaan patogen pada produk pangan tidak serta merta memberikan risiko terhadap kesehatan publik (misalnya keberadaan patogen pembentuk spora pada produk pangan yang tidakcocok untuk pertumbuhan patogen tersebut).

• Jika produk pangan bersifat mendukung pertumbuhan patogen tertentu, maka lamanya masa simpan akan berpengaruh pada potensi risiko kesehatan publik. Misalnya mikroba pembentukspora kemungkinan tidak akan terbunuh pada proses pasteurisasi, tetapi jumlah atau populasinyadapat dikendalikan selama proses penyimpanan pada suhu rendah. Dengan demikian, lama penyimpanan produk pada suhu tinggi akan meningkatan potensi risiko kesehatan publik.

• Proses pasteurisasi tidak lagi dapat berfungsi memberikan perlindungan jika produk pangan mengalami pencemaran atau kontaminasi setelah proses pasteurisasi atau setelah kemasanproduk telah dibuka.

• Risiko kesehatan publik ini dipengaruhi oleh jumlah patogen pada produk dan jumlah dan frekuensi konsumsinya. Oleh karena itu penentuan “jumlah akhir yang tidak lagi memberikanrisiko terhadap kesehatan publik” juga harus mempertimbangkan data konsumsi (selain data epidemiologi).



5. “…produk disimpan dan didistribusikan pada kondisi normal.”

• Tujuan utama proses pasteurisasi adalah untuk memberikan perlindungan padakesehatan publik. Proses pasteurisasi tidak dirancang untuk membunuh mikrobasehingga produk menjadi awet pada suhu ruang.

• Industri harus memberikan spesifikasi suhu ”normal” penyimpanan yang disarankan, sehingga produk akan tetap aman. Umumnya produk pasteurisasi memerlukan penyimpanan pada suhu rendah (suhu refrigerasi) dengan persyaratan suhupenyimpanan yang tepat juga dipengaruhi oleh jenis produknya.

• Dalam hal ini proses pasteurisasi harus secara jelas dibedakan dengan dengan proses sterilisasi (sterilisasi komersial). Seperti telah dikemukakan tadi, bahwa produkpasteurisasi memerlukan penyimpanan refrigerasi sedangkan produk pangan sterilkomersial bersifat stabil pada suhu kamar (bersifat shelf stable). Walaupun demikian proses pasteurisasi dengan kombinasi perlakuan lain (misalnya pengendalian pH) dapatpula menghasilkan produk yang bersifat shelf stable.


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• Conduct a hazard analysis to identify the microorganism(s) of public health concern for the food.

• Determine the most resistant pathogen of public health concern that is likely to survive the process.

• Assess the level of inactivation needed. Ideally, this would involve determining the initial cell numbers and normal variation in concentration that occurs before pasteurization.

• Consider the impact of the food matrix on pathogen survival.

• Validate the efficacy of the pasteurization process.

• Define the critical limits that need to be met during processing so that the food will meet the performance standard.

• Define the specific equipment and operating parameters for the proposed pasteurization process This may include developing specific Good Manufacturing Practices (GMPs) in addition to the Hazard Analysis Critical Control Point (HACCP) system.

NACMCF guidelines to developing a proposed pasteurization process :


= f (food‐pathogen combinations)

• Egg (liquid) 8.75‐log10 reduction of Salmonella

• Egg (in‐shell) 5‐log reduction of Salmonella

• Beef (e.g., cooked beef, roast beef, cooked corn beef, and cooked poultry products) 6.5‐log10 reduction of Salmonella

• Pultry 7‐log10 reduction of Salmonella.

• Fishery products 6‐log10 reduction of L. monocytogenes

• Crabmeat based on shelf life extension and significantly exceeds a 12‐log10 reduction of type E non‐proteolytic C. botulinum

• Juice 5‐log10 reduction of the most resistant microorganism of public health significance

NACMCF : Scientific criteria to determine if a process is

equivalent to pasteurization?

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Parameter ketahanan panas mikroba Coxiella burnetii,dengan nilai Z=4,34oC = 8oF (Ocerf and Condron, 2006).

= f (food‐pathogen combinations)

• Milk 6‐log10 reduction of Coxiella burnetii

NACMCF : Scientific criteria to determine if a process is

equivalent to pasteurization?


Regulasi mengenai kecukupan proses pasteurisasi pada susu (the FDA Pasteurized Milk Ordinance by US FDA; NACMCF, 2006).

161

8 10 . = 15 detik

SUSU PASTEURISASI

NACMCF• Milk 6‐log10 reduction of Coxiella burnetii

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SUSU PASTEURISASI

US FDA (PMO, 21 CFR 1240.61)• Milk 6‐log10 reduction of Coxiella burnetii

1. In the case of thermal pasteurization of milk and milk products, the most resistant human pathogen known organism is C. burnetii.

2. The thermal process must be applied at levels of intensity that will inactivate the most resistant pathogen and assure the safety of the pasteurized milk or milk product.

3. The thermal process must be applied in properly designed and operated equipment, and is dependent on raw material quality.

4. There must be some means for regulators in those jurisdictions that are receiving the pasteurized milk and milk products to independently verify that the thermal process has been adequately applied*).

____________

*) In the case of milk and milk products, the phosphatase test is commonly used for this purpose.


SUSU PASTEURISASI

US FDA (PMO, 21 CFR 1240.61)• Milk 6‐log10 reduction of Coxiella burnetii

• EQUIVALENCE OF PASTEURIZATION PROCESSES??

Processes other than thermal pasteurization, which are proposed to be applied to milk and milk products, must be recognized by FDA as equally efficient in the destruction of microbial organisms of public health significance.

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• FAO/WHO (2004) defined pasteurization as “A microbiocidal heat treatment aimed at reducing the number of any pathogenic microorganisms in milk and liquid milk products, if present, to a level at which they do not constitute a significant health hazard.

• Pasteurization conditions are designed to effectively destroy the organisms Coxiella burnetii.

• Pasteurization was designed to achieve at least a 5-log reduction of C. burnetiiin whole milk.

• Pasteurization efficiency can be determined by Phosphatase test.

• Alkaline phosphatase, an enzyme naturally present in milk of all mammals have a thermal resistance greater than that of the most heat resistant non-spore-forming pathogens commonly found in milk its destruction confirms proper pasteurization

• Positive Phosphatase activity is the indicative of inadequate pasteurization or contamination of pasteurized milk with raw milk or post-process bacterial contamination.

SUSU PASTEURISASI

FAO/WHO (2004) :


SUSU PASTEURISASI

Diskripsi

Susu pasteurisasi adalah susu segar, susu rekonstitusi, susu rekombinasi yang telah mengalami prosss pemanasan padatemperatur 63°C ‐66°C selama minimum 30 menit atau padapemanasan 72°C selama minimum 15 detik, kemudian segeradidinginkan sampai 10°C, selanjutnya diperlakukan secara aseptisdan disimpan pada suhu maksimum 4,4°C.

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SUSU PASTEURISASI

Diskripsi

Susu pasteurisasi adalah susu segar, susu rekonstitusi, susu rekombinasi yang telah mengalami

prosss pemanasan pada temperatur 63°C ‐66°C selama minimum 30 menit atau padapemanasan 72°C selama minimum 15 detik, kemudian segera didinginkan sampai 10°C,

selanjutnya diperlakukan secara aseptis dan disimpan pada suhu maksimum 4,4°C.

63°C, 30 menit72°C , 15 detik

• Sesuai dengan Pasteurized Milk Ordinance/PMO (US‐FDA)

• Ekivalen dengan penurunan Coxiellaburnetii sebesar 6 Log


SUSU PASTEURISASI

CHECK: Microbiological Specifications for Foods

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• Pulsed electric field (PEF) treatment involves the application of high voltage (typically 20‐80 kV/cm) to foods placed between two electrodes.

SUSU PASTEURISASIPEF_____________


• Energy loss due to heating foods is minimized, reducing detrimental changes of the sensory and physical properties of foods.

• Destruction of microbial cells is the result of electroporation of cell membranes.

• The process can be static (batch) or continuous.

• Considerable data have been published that support the adequacy of PEF technology as a feasible pasteurization treatment for fluids.

• Inactivation as electromechanical instability in the cell membrane at a critical electric field strength increasing field strength correlated with increased leakage and the loss of ability to maintain pH homeostasis ‘fatal event’ is the membrane damage.


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NACMCF (2006)

1. What are the scientific criteria that should be used to determine if PEF

treatment is equivalent to pasteurization?

• Critical Product Characteristics:• Electrical conductivity, ionic strength, pH, water activity, particulate

size and content, viscosity• Critical equipment and operating parameters:

• Equipment design, including static (batch) versus continuous processing, • Flow rate (if applicable), pulse width, pulse frequency and duration,

and electrical field strength. • Additional hurdles?

• organic acids• ????



NACMCF (2006)

2. What is the most resistant microorganism of public health significance for

PEF treatment?

• Rotovirus is completely resistant to PEF processing, as it does not have a lipid membrane.

• Yeast cells are more susceptible to PEF treatment than bacterial cells

the most resistant strains of a pathogenic species must be identified for PEF process optimization and validation.


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NACMCF (2006)

3. What biological hazards might be created as a consequence of PEF

treatment?

• A potential consequence of sub‐lethal treatment of PEF cells that may later repair and multiply under storage conditions.

• Assurance of application of a critical electric field (Ec)

• At less than the critical level, damage is reversible

• Once a critical electric field (Ec) is applied, cells are essentially completely inactivated.




Square pulse generator using a pulse-forming network of 3 capacitors inductor units and a voltage trace across the treatment chamber

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KINETICS :

GENERAL• Intensity applied should be above the threshold electric field intensity, the critical electric field intensity for the target microorganism.

where: • DR= decimal reduction time at a reference electric field intensity (ER),

• z(E) = the increase in electric field intensity (E) required to reduce the decimal reduction time (D) by I‐log cycle at a specific temperature and pressure.

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KINETICS :Lack of agreement among researchers on the best way to define the microbial inactivation kinetics of PEF processing.


Microbial survival fraction as a function of (A) E, electric field and (B) t, treatment timeB = kinetic constants, subindex: e, electric field, t, time, c, critical.E is the critical electric field obtained by the extrapolated value of E for 100% survival.t is the critical treatment time obtained by the extrapolated value of t for 100% survival

A B

Critical electric field (Ec)



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t = treatment time, tc = critical treatment time, Ec= critical electric field intensity,and K = the kinetic constant.

K values calculated by fitting experimental data




Onother model (Peleg, 1995):

where: • Ed= the electric field intensity when microbial population has

been reduced by 50%. • K = a coefficient with magnitude based on the slope of the

survivor curve obtained at several levels of electric field intensity.

S =

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Onother model (Peleg, 1995):


SUSU PASTEURISASIPEF___ ~ Ekivalensi

How to assess “As Equally Efficicent”? Use of Microbiological Specification of Pasteurized Milk

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The Performance Criterion (PC) could be defined as the effect on frequency and/or concentration of a hazard in a food that must be

achieved by the application of one or more control measures to provide or contribute to a Performance Objective (PO) or a FSO (NACMCF

2006).

In milk a FSO can be considered as achieving a low probability that a serving of milk contains a viable vegetative cell of a pathogen (e.g. < 1

cell per 1,000 servings), and a PC as a treatment sufficient to reduce the levels of C. burnettii by greater than 6-log cycles

SUSU PASTEURISASIPEF___ ~ Ekivalensi

How to assess “As Equally Efficicent”? Use of Microbiological Specification of Pasteurized Milk


Critical Process Factors and How they Impact Microbial Inactivation

Process factors a) Electric field intensity. b) Treatment time. c) Pulse waveshape. d) Treatment temperature.

Product factors a) Conductivity, pH, and ionic strength.b) Particulate foods. c) Hurdle approach.

Microbial factors a) Type of microorganismsb) Concentration ofmicroorganisms. c) Growth stage of microorganisms.

SUSU PASTEURISASIPEF___ ~ Faktor Kritis

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SUSU PASTEURISASIPEF___ ~ Faktor Kritis


Terima kasih . . . . .


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SCIENTIFIC PARAMETERS FOR ESTABLISHING THE …phariyadi.staff.ipb.ac.id/files/2018/05/MPTP-2018-Ekuivalensi-P... · Atau, satu perlakuan sajasebetulnya cukup untuk ... sekarang banyakpula