OUR INDUSTRY TODAY Ultra-High Temperature Processing and Aseptic Packaging of Dairy Products ABSTRACT This status summary was prepared for participants in a National Workshop on Research Opportunities for the Dairy Foods Industry held in Berkeley, CA, November 1986. It presents brief discus- sions of regulations that influence prog- ress in commercial manufacture of UHT products, equipment, and processes used in the US and elsewhere, changes in prod- ucts during UHT processing and storage, some economic and consumer-related considerations, quality assurance for UHT Products, and suggestions for future research INTRODUCTION Heat treatments at ultra-high temperatures for very short times cause extensive bacterial destruction with less damage to food quality (flavor, nutrient losses, color, ete.) than tradi- tional methods of food sterilization in con- tainers. To achieve the benefits of UHT pro- cessing, products are heated and cooled rapidly, usually in continuous flow, followed by aseptic packaging For many years the terms UHT and UBT Long Life have been commonly used in much of the world to designate milk products that are subjected to a UHT treatment and packaged aseptically. These products have extended shelf life without refrigeration, In the US, UHT was the name adopted for such products at the 1984 meeting of the Interstate Milk Shipments Conference, and subsequently it was approved by the US FDA. Received December 29, 1986. Accepted May 28, 1987. 1987 J Daity Sei 70:2192-2202 W. L, DUNKLEY and K. €, STEVENSON Department of Food Science and Technology University of California Davis and National Food Processors Association Dublin, CA Two important differences between UHT products and ultrapasteurized products must be recognized. The Grade A Pasteurized Milk Ordinance (PMO) (15) specifies standards for time and temperature of heat treatments for pasteurization and ultrapasteurization. In contrast, processes for UHT products are not detailed in regulations but are established as specified in regulations for thermally pro- cessed low acid foods. Processing authorities specify, for an individual product or a group of products, the temperature and time of heat treatment and other processing conditions appropriate for the equipment to be used. The second important difference is that ultra- pasteurized products must be refrigerated, but UHT products have extended shelf life without refrigeration. In Europe, UHT milk was introduced com- mercially in cans during the 1950’s and in cartons during the 1960's. Thus, European experience with UHT milk and milk-based products is pertinent in predicting commercial success of such products here, assuming that regulatory constraints will be revised in accord- ance with new information regarding the scien- tific and technological bases for the products. In some European countries, consumption of UHT milk equals or exceeds that of pasteurized milk, In Canada, a major application of UHT is for specialty products, such as flavored milks, creams, and drinkable yogurts, which have high rates of return when distributed as pasteurized products and which require extended shelf life for efficient distribution. Consumers accus- tomed to UHT products find them acceptable and appreciate the convenience of long keeping quality without refrigeration. More widespread use of UHT milk and milk-based products in the US can be expected as the products become more available, as increased volume lowers cost 2192OUR INDUSTRY TODAY of production and distribution, and as research and technological development lead to im- proved quality and greater variety of products. REGULATIONS. European Versus US Approach Differences between regulations in the US and Europe have profoundly influenced the development of aseptic equipment (41). For example, in the US before 1981 the James Dole Corp. aseptic canning system was the only aseptic filling and packaging system of commer- cial importance for UHT milk and milk-based (low acid) products, In 1981, FDA approval of the food additive petition for use of hydrogen peroxide as a sterilant for food contact surfaces provided the impetus for introduction of various aseptic filling and packaging systems into the US market. Staal (40) described regulations pertaining to UHT mitk in the US and Europe, but he did not address differences in regulations. Most Euro- pean regulations rely on spoilage data as a mea- sure of how well an aseptic system works. The FDA, however, requires microbiological (chal- lenge) and chemical tests to document whether an aseptic system provides an adequate margin of safety. Lack of understanding of this differ- ence has hampered adoption of “European” aseptic packaging systems in the US. Food and Drug Administration and US Department of Agriculture Regulations for UHT milk and milk-based products that contain little or no meat or poultry are contained in Title 21 of the Code of Federal Regulations (CFR), parts 108, 113, and 114, Section 113.40(g) lists specific require- ments for aseptic processing and packaging systems. The UHT milk-based products that contain at least 3% raw meat or 2% cooked poultry are regulated by the USDA. The USDA has developed Guidelines for Aseptic Processing and Packaging Systems in Meat and Poultry Plants (45), which describes their requirements for obtaining approval for aseptic processing and packaging systems. Pasteurized Milk Ordinance Processors of UHT milk or milk-based prod- ucts must adhere to the appropriate FDA and 2193 USDA regulations and guidelines cited and also the requirements imposed by the PMO. The PMO was revised in 1983 and 1985 to include UHT milk (15). Unfortunately, there are some conflicts between requirements in the PMO and 21 CFR 113, There is a distinct need for revi- sions in the PMO and 21 CFR 113 to make these regulations compatible and up-to-date. State Regulations Many states actively regulate the processing of food products, but, in general, their regula- tions have had little effect on aseptic proces- sing. Two major exceptions include PMO- regulated products in states where the PMO is adopted and enforced, and products produced in California, where the state Department of Health Services issues all processes for acidified and low acid foods produced in California, and the state Department of Food and Agriculture has regulations similar to those in the PMO. Hazard Analysis Critical Control Point Approach The Hazard Analysis Critical Control Point (HACCP) system has been successfully applied by the FDA to the regulation of acidified and low acid canned foods. A recent report by the Food and Nutrition Board Subcommittee on Microbiological Criteria (16) recommended the HACCP system be applied by industry and regulatory agencies to all US food protection programs ULTRA-HIGH TEMPERATURE PROCESSING Ultra-High Temperature Processing Equipment Several reviews and proceedings of symposia, are available that provide excellent descriptions of UHT processing and aseptic packaging equip- ment (3, 6, 8, 22, 30, 38). Recent trends and advances have focused on equipment that can be used for processing products that contain particulates (28, 31, 46) and on various aspects related to automated control. Establishing Ultra-High Temperature Processes. Food and Drug Administration regulations require that scheduled thermal processes for low acid foods be established by qualified Journal of Dairy Science Vol. 70, No. 10, 19872194 persons having expert knowledge of thermal processing requirements and having adequate facilities for making such determinations (21 CFR 113.83). A processing authority could be an individual, but in practice it is usually an organization such as National Food Processors Association, Some large food companies may have sufficient expertise and facilities to act as their own processing authorities. In California, all thermal processes for low acid and acidified foods are issued by the state Department of Health Services. To assure safety of products, processes for low acid foods must ensure that Clostridium botulinum spores will not survive, Processes are based upon the resistance of spores in the prod- uct and the maximum number of spores that could be present along with the addition of ap- propriate safety factors, Regulations also provide for achieving “commercial sterility,” that is, that the processes render foods free of micro- organisms capable of reproducing in the foods under normal unreftigerated conditions of stor- age and distribution. This necessitates con- sideration of numerous factors, such as types of organisms likely to cause spoilage, their thermal resistance in the food, their ability to grow under expected storage conditions, and num- bers of organisms that might be present ini- tially. In UHT milk, commercial sterility re- quires more severe heat treatment than that needed to destroy C. botulinum spores. Traditional processes for aseptic products in the US have been based upon the minimum temperature and the minimum residence time in the hold tube. These standards tend to result in a relatively conservative process, because the product must be heated above the minimum ‘temperature in the product heater, no heat may be applied to the hold tube, and with few exceptions, all of the calculated lethalit sidered to occur in the hold tube (28) Processes employed in the US are usually more severe than those employed in Europe. ‘An example of a process for UHT milk is to hold products at a minimum of 137.8°C (280°F) for at least 6.5 s or an equivalent (z = 10°C) process based upon turbulent flow in the hold tube, More severe treatments are used for some flavored milk and formulated milk products, These processes should be re- evaluated to determine whether lower tempera~ tures or shorter times could be used to mini- is con- Journal of Dairy Science Vol. 70, No. 10, 1987 DUNKLEY AND STEVENSON mize heated flavors, Existing data should be studied critically, especially with respect to identity of sporeformers that cause spoilage, their heat resistance, whether inhibitors in UNT milk influence their growth, and numbers of spores present in US Grade A milk supplies. Microorganisms of public health significance must receive special consideration. If new infor- mation is needed, research to develop it should receive high priority. With each new processing installation, packs usually are made of milk and milk products inoculated with a test organism to determine that the calculated process provides commer- cial sterility and chat the equipment is installed and operating properly. These tests will become more important in confirming the efficacy of processes for products containing particulates. Comparisons of Ultra-High Temperature Systems Many studies have been conducted that com- pared effects on products of different proces- sing systems. In some of these studies, the lethality of the processes was not comparable, either because lethal effects during heating and cooling were not considered or because the pro- cesses may have included variability of heating of individual milk particles (as in injection heat- ing) or variability of residence time (as in the discharge from infusion heaters) (33). Relia- bility of evaluations of lethal effects is limited by the inadequacy of information such as tem- perature dependence of viscosity and of heat transfer coefficients at UHT temperatures (28). Additional research is needed with improved equipment and with adequate consideration of variables such as those noted. ASEPTIC FILLING AND PACKAGING Aseptic Filling and Packaging Equipment Stevenson (41) and others feg., (3, 6, 8 22)) have provided general reviews of aseptic packaging, Table 1 lists general categories of aseptic filling and packaging systems based upon the types of containers and the methods of forming the containers, and provides some examples of systems for each of the categories. ‘The Dole canning system and Tetra Pak machines are the most common aseptic units used for packing UHT milk and (low acid) milkOUR INDUSTRY TODAY 2195 TABLE 1, Classification of aseptic filling and packaging systems." Category Examples of systems 1. Metal and rigid containers sterilized by heat Steam/metal containers Hot air composite can 2, Webfed paperboard sterilized by H,0, 3. Preformed paperboard containers 4, Preformed rigid/plastic containers 5, Thermoform-fill seal 6, Flexible plastic containers Bagin-box type Pouches Blowmolded Dole canning systems Drum fillers, ¢.g., Scholle, FranRiea, Imdec Dole hot air'system ‘Tecra Pak (Brik Pak) International Paper Combibloc LiquiPak Metal Box, Fresh Fill Gasti Crosscheck Benco Asepack Bosch Servac Conoftast Thermoforming USA Scholle LiquiBox Asepak Prepac Prodo Pak Bortlepack Serac "From Stevenson (41). products in the US. The lower cost of flexible packaging materials compared with metal for cans has stimulated increased interest in form- fill-seal aseptic packaging machines, Stevenson (41) summarized recent developments and trends in aseptic systems in the US. In many instances the aseptic filling and packaging equipment used in Europe for UHT milk and milk products does not meet require- ments in the US regulations [21 CFR 1134g (2)]. Before equipment is approved for use, tests must be conducted to show that the ‘equipment can: 1) bring the equipment to a condition of commercial sterility prior to pro- duction; 2) sterilize the air delivery system and produce sterile air; 3) sterilize the containers and lidding material; and 4) maintain sterility during production, In addition, the FDA re- quires establishment of critical factors for each unit and of appropriate monitors and controls for the critical factors, Davis and Dignan (12) provided information concerning these topics and the regulatory issues associated with packaging foods in aseptic systems that utilize hydrogen peroxide for equipment or package ‘rends in aseptic filling and packaging sys- tems related to UHT milk and milk products include: 1) redesign of filling equipment to include use of dispensing pumps or multiple filling heads; 2) increase in the variety of packaging materials and introduction of addi: tional convenience features (eg., opening tabs, tamper-evident packaging, microwavable trays, cups, and bowls); and 3) increase in rates of production and use of bulk fillers for low acid products. Product-Related Issues Some potential problems are associated with UHT creamer-type products produced in small cups. Many of these products are labeled and marketed as refrigerated foods, and thus, they are not regulated under 21 CFR 113, However, if hydrogen peroxide is used to sterilize the pack- aging material, it must be used in accordance with the requirements in 21 CFR 178.1005. Journal of Dairy Science Vol. 70, No. 10, 19872196 Some UHT creamertype products are not refrigerated and therefore must meet the requirements of 21 CFR 113 (and 21 CFR 178.1005, if hydrogen peroxide is used), To our knowledge, low acid processes have not been filed for these products, and the aseptic filling and packaging systems for small creamer packages have not been shown to meet the requirements in 21 CFR 113. Similarly, some processed cheese products are produced with aseptic filling and packaging equipment that does not comply with the low acid food regu- lations. Until now, the FDA has not taken many adverse actions against these products however, with the recent increase in FDA in- spection activities related to the dairy industry, these UHT unrefrigerated creamers and pro- cessed cheese products are in jeopardy with respect to the areas cited. EFFECTS OF HEAT TREATMENTS AND STORAGE Recent reviews (7, 9, 24, 29, 36, 37, and others) present the theoretical basis for UNT and aseptic processing and provide comprehen- sive summaries of research on changes that occur during heat treatments and storage of UHT products. Destruction of Microorganisms Destruction of microorganisms during UHT processing has been discussed (9, 29, 34, 43, 47, and others). There is some concern that the variation of death rate wich temperature may change at the higher temperatures utilized for UHT processes (9, 28). However, the prepond- erance of data indicates that the variation with temperature between 100 and 145°C for a specific spore crop remains constant or varies only insignificantly, There is a need to obtain additional thermal resistance data at UHT Process temperatures for spores of C, botu linum and for organisms of significance with respect to commercial sterility for a variety of milk produets Changes in Milk Proteins The milk constituents that undergo the greatest change during UHT processing and storage are proteins, Alterations in proteins are related to many technological problems with UHT products, such as flavor, gelation, sediment Journal of Dairy Science Vol. 70, No. 10, 1987 DUNKLEY AND STEVENSON formation, fouling of heat transfer surfaces, loss of nutritional value, and browning ‘The principal effect of UHT treatment on caseins is a change in distribution of sizes of the micelles (9). In general, micelle size increases, but this phenomenon is accompanied by in- creased numbers of very small particles and in the amount of soluble caseins, Little is known about the kinetics of these changes and whether they influence changes in physical properties such as gelation and sediment formation. When whey proteins are denatured, they form complexes with themselves, with caseins, and with fat globules. The nature of these com- plexes is markedly influenced by the conditions of heating, The individual whey proteins vary in heat stability: f-lactoglobulin and a-lactal- bumin are more heat resistant than bovine serum albumin. Limited kinetic studies of denaturation of individual whey proteins indicate that the kinetics differ depending on whether the heat treatment is below or above 90 to 100°C. Enzyme Inactivation During the last 10 yr, extensive research reported the presence and characteristics of heat-resistant enzymes in milk and their effects on UHT products during storage (1, 13, 23, 27, 42). Proteases and lipases are of greatest con- cern, Identification of heat resistant proteases produced by psychrotrophic bacteria stimu- lated active research on this subject. Recently increased attention has been directed to the role of native proteases in milk, especially plasmin, In early studies, investigators attributed the presence of an enzyme in UHT milk to reactiva- tion. Discovery of heat-resistant enzymes that are not completely destroyed by UHT treat- ment necessitates reevaluation of some early conclusions, Development of sensitive assays for enzyme activity has been important for recognition of the role of enzymes in deteriora- tion of UHT products during storage, especially with respect to changes in flavor and physical stability. Nutritional Changes Changes in the nutritive value of UHT milk during heat treatment and in subsequent storage have been reviewed comprehensivelyOUR INDUSTRY TODAY by Renner (36). Ford and Thompson (18) concluded: UHT processing of milk causes very little im- Pairment of nutritional qualicy, but during storage after aseptic filling there may be signi cant losses of several nutrients, Of critical im- Portance in this connection are temperature of storage, the initial oxygen content of the milk, and the nature of the packaging material (opa- city and permeability to oxygen). The nutri- tional quality is best conserved by hermetic packaging of deaerated milk into opaque con- tainers and, ideally, storing under refrigeration Future research related to nutritive value of UHT produets will probably be most produe- tive if emphasis is given to minimizing losses during storage. Flavor Flavor is the one property that most seri- ously limits acceptability of UHT milk products in US. Changes in flavor during storage are at least as important as those caused by the UHT treatment. Research on flavor of UHT milk has been reviewed elsewhere (5, 29). The dominant characteristic of freshly processed UHT milk is a cooked flavor. During storage, cooked flavor decreases in intensity, and other characteristics become evident. These vary in origin and sensory properties and include “UHT flavor” and stale flavors. After prolonged storage, stale flavors limit accept- ability of the product. Typically, flavor accept- ability increases during the first few weeks of storage as intensity of the cooked flavor de- creases; then acceptability decreases as stale flavors increase. The rates of change of flavor characteristics are influenced by many vari- ables, including properties of the milk, intensity of the heat treatment, type of processing equip- ment, type of package, concentration of oxygen, and time and temperature of storage. Badings et al. (4) described the effects of different heat treatments on milk flavor. Pasteurized milk has a bland flavor, which differs little from fresh raw milk. At higher processing temperatures, “cooked” flavor be- comes apparent. This flavor is caused particu- larly by hydrogen sulfide, which is formed by thermal degradation of B-lactoglobulin and pro- teins from the fat globule membrane. Other flavor compounds contribute to a smaller 2197 extent. Processing with UHT results in a typical “UHT-milk” flavor caused particularly by ketones, lactones, and sulfur compounds. Milk lipids are the most important source of the UHT flavor. Milk subjected to more intense heat treatment has a typical “sterilization” or “caramelization” flavor. The overall flavor impression results from caramelization and Maillard reactions. As the intensity of the heat treatment is in- creased, there is initially a parallel increase in concentration of hydrogen sulfide. However, with treatment that is more severe than the minimum used for UHT processing, hydrogen sulfide concentration decreases, probably be- cause of further reactions of hydrogen sulfide with other milk constituents or their degrada- tion products. Processing and packaging influ- ence the intensity of the cooked flavor through their influence on formation of volatile flavor compounds (heat treatment), removal of flavor compounds (vacuum cooling), and oxidative reactions (oxygen concentration in the milk, storage temperature, properties of the package). ‘The cooked flavor can be reduced by use of chemical additives (eg., cystine) or by aseptic addition of sulfhydryl oxidase after the UHT treatment, but these approaches have not been adopted commercially, The cooked flavor is not as serious a limitation on acceptability as other flavors, especially stale flavors that develop during storage. Processing and storage conditions influence the concentrations of lactones, aldehydes, and ketones that are formed during heat treatments and also during storage. Variability of fatty acid composition also influences the formation of such compounds. Extensive research reviewed by Bassette and Mantha (5) and Mchta (29) has provided helpful information about volatile compounds in UHT products, but there is dis agreement regarding their role in contributing to stale flavors. Bassette, Rerkrai, and Jeon (personal communication) developed a pro- cedure for concentration of a compound(s) that reproduces the stale flavor when added to milk ‘This procedure has promise for use in future research on stale flavor. Oxidized flavor is not as serious a problem with UHT as with pasteurized milk, probably because of the antioxidant effect of the high temperatures of processing and the low con- centration of oxygen in the product. Research Journal of Dairy Science Vol. 70, No. 10, 19872198 on heat-resistant proteases and lipases is con- tributing to our understanding of the origins of bitter and rancid flavors during storage of UHT products. Fat Separation Fat separation can occur either in the form of a creamy layer, which mixes in easily, or as a cream plug, which is difficult to disperse. Because UHT milk is stored for extended periods (eg., 4 to 12 mo) at room tempera- ture, preventing separation of fat is a more serious problem than with pasteurized or ultra- pasteurized products stored under refrigeration for much shorter times. Efficient homogeniza- tion is very important for products without additives that retard fat separation, such as stabilizers in chocolate milk or acidulants that increase the viscosity of acidified products Homogenizing efficiency is influenced by such processing variables as homogenizing pressure and temperature, deaeration, valve design, and location of homogenization in the processing sequence. Milk supplies vary in efficiency of homogenizing treatments in dispersal of fat. Much still remains to be learned about design of homogenizing valves to achieve maximum dispersion (35). Golation and Sedimentation Defects of gelation and sedimentation are discussed together because some investigators consider them to be manifestations of related physical stability problems. Similar conditions appear to influence both defects, but if gelation occurs rapidly, it prevents sedimentation. Some processors consider gelation to be the defect that most seriously limits the shelf life of their products. There are marked differences in inci- dence of gelation in UHT milks in relation to milk supplies, geographic location, and pro- cessing conditions (especially heat treatments) and storage conditions. Investigators are not in agreement regarding the mechanism of gelation (21), Perhaps there are two mechanisms, one primarily physico-chemical, the other enzy- matic. Australian workers (25) postulated that some proteolytic activity, perhaps from heat-resistant enzymes, is needed to provide conditions for gelation by a predominantly physico-chemical mechanism. Further research is needed to establish the role of both native Journal of Dairy Science Vol, 70, No. 10, 1987 DUNKLEY AND STEVENSON proteases and those produced by bacteria in the proteolysis and gelation of UHT products. ‘The relation between these proteases and any protease inhibitors or activators must also be established. Color The color of UHT milk is influenced by many factors such as composition of the milk, changes in size distributions of particles as a result of homogenization and heat treatment, and Maillard reactions during heat treatments and storage. Color is not considered a defect that limits acceptability of milk, but it is of concer for products that contain increased concentrations of reducing sugars. Special Considerations for Milk-Based Products Defects that limit acceptability of UHT products differ among products. In comparison with whole milk, the initial flavor of lowfat milk is more acceptable because of lower inten- sities of cooked and UHT or lactone flavors, but stale flavors develop similarly in both during storage, Whipping cream has greater intensity of cooked and lactone flavors when fresh and is more susceptible to development of oxidized flavor, fat separation, and gelation, so it is usually stored under refrigeration. Oxidized flavor is a problem with acidified products also. Chocolate milks contain stabilizers that, when effective, retard or prevent settling of cocoa. The dominant chocolate flavor masks other flavors enough to give UHT chocolate milks acceptability comparable with pasteurized products. Goat milk is particularly susceptible to physical instability, which leads to sediment formation, but this can be prevented by pH adjustment or by addition of phosphate salts (48). Concentrated UHT milks are very suscep- tible to gelation (21). Research has demon strated that addition of polyphosphate salts can delay gelation, but results seem to be variable and depend on both the milk and the polyphos- phate used. Lactose-hydrolyzed milk is very susceptible to browning during storage because of the increased concentration of reducing sugars. Ice cream and ice milk mixes present problems with flavor deterioration, browning, and gelation, In cheese sauces and related prod- ucts, physical properties are adjusted by use‘OUR INDUSTRY TODAY of stabilizers and other constituents. Flavor changes are similar to those in milk, but some cheese products are subject to browning. Milk- based puddings are successful commercially. ‘Their physical properties can be controlled by appropriate selection of ingredients, but stale flavor develops during storage, especially in bland-flavored products, MARKETING AND DISTRIBUTION In the US, consumers are poorly informed about UHT products. Common misconceptions relate to what they are, whether preservatives are used in them, their nutritive value, and ad- vantages and disadvantages when compared with pasteurized products. Research is needed to guide consumer education and advertising programs for UHT products. Where UHT products are readily available in Europe and Canada, their retail prices are simi- lar to (and in Western Germany lower than) those for their pasteurized counterparts. Some analyses project large savings in distribution costs from increased use in the US of unrefrige- rated UHT products (2), More research is needed on economics of production and dis tribution of UHT products (26) QUALITY ASSURANCE Currently, few processors manufacture UHT. milk and related products for the US market. Therefore, the industry has had little oppor- tunity to develop successful quality assurance programs comparable with those used in estab- lished segments of the dairy industry. Programs for quality assurance of UHT products differ appreciably from those for pasteurized products because of the marked differences between the two groups of prod- ucts. The UHT products are expected to be sterile and to keep well for months without refrigeration, Microbiological problems consist mainly of detection of the small number of packages that spoil, and identification and cor- rection of causes of the spoilage. Much of the bacterial spoilage results from container de- fects, rather than from factors related to processing or the product itself, Most defects that limit acceptability of UHT products after extended storage result from chemical, enzy- matic, and physical changes. 2199 ‘The guidelines prepared by the USDA (45) include a section on quality control that lists numerous topics of concern in process control, product evaluation, and recordkeeping in quality assurance programs for UHT products. Shew (39) discussed technical aspects of quality assurance for UHT products. Microbiological Testing Contrary to some beliefs, microbiological testing cannot be used to ensure commercial sterility. The best way to obtain a commer- cially sterile product is to document adher- ence to a scientifically established process with properly operating equipment and reliably sealed containers. Microbiological (incubation) tests may be used as an adjunct to such pro- cedures, Routine incubation tests are recom- mended as a check on overall quality and sterility of aseptic products. In some instances (eg., USDA-regulated products) routine incuba~ tion tests are mandatory and the sampling fre- quency is set. In general, this is not the case. Routine incubation and testing should be con- ducted on a representative number of samples from each lot of product, and appropriate records must be maintained. For rapid detec- tion of spoilage, use is made of simple criteria such as bulging container and changes in pH, odor, and physical appearance of the product. Interpretation of “positive” samples is im- portant. When processing records document that an appropriate process was used, it is extremely unlikely that underprocessing is the cause of spoilage, However, if the spoilage flora are solely spore-forming rods, underprocessing should be suspected. If the spoilage flora con- tains a mixed population including heat-labile organisms, the cause of spoilage is postprocess contamination. This situation could be due to recontamination in the processing of packaging equipment or to problems with container integ- rity, [See (11) and (32) for further discussions on testing methods and interpretation of results.] An important research need is develop- ment and evaluation of nondestructive methods for detecting nonsterile containers. Container Integrity ‘The low acid food regulations require inspec- tion of container closures, recording of defects found and corrective actions taken, and tests at Journal of Dairy Science Vol. 70, No. 10, 19872200 sufficient intervals to ensure that reliable seals are formed (21 CFR 113.60). There is no single set of tests that can be recommended for asep- tic containers, Test methods are changing and the most applicable source of information for a given container type is normally the container supplier, Additional information is contained in the FDA’s Bacteriological Analytical Manual (14), USDA's Test Cycles for Small Size Semi- rigid Containers (44), and the Aseptic Proces- sing and Packaging Supplement to the Food Processors Institute Canned Foods Manual (17). Ic is imperative that appropriate quality con- trol test methods be used. Detection of Hydragen Peroxide Residuals Hydrogen peroxide is approved for use as a sterilant for food contact surfaces of certain materials provided that the maximum residue is less than ot equal to .5 ppm hydrogen peroxide when packages are filled with distilled water [CER Part 178.1005 and (12)}. Chin (10) re~ viewed analytical methods for measuring residuals of hydrogen peroxide with special consideration to new methods that have pro- mise for use in quality control. Milk Quality In the US, milk meeting requirements for Grade A (or even manufacturing grade) is of such quality that bacteria do not cause off- flavors or decrease heat stability of the milk. Raw milk must be examined routinely for anti- biotics and defects such as feed, rancid, and oxidized flavors. Properties related to milk quality of concern to UHT milk processors in- dude heat-resistant enzymes and changes in flavor and physical properties during storage. ‘The industry needs improved simple tests for use in quality control to select milk in relation to such properties. Studies of heat-resistant proteases lipases produced by psychrotrophic bacteria have led to the development of a number of sensitive assays for enzymatic activity and prod- ucts of enzyme reactions. Reports on correla~ tions of enzyme activity with development of defects (eg., gelation and bitter and rancid flavors) have been inconsistent. More research is needed to explain such inconsistencies and to guide selection of tests that would be appro- priate for quality control. Some investigators and Journal of Dairy Seience Vol. 70, No. 10, 1987 DUNKLEY AND STEVENSON are enthusiastic about potential benefits of applying the limulus test to processed prod- ucts to assess growth of psychrotrophic bacteria in the raw milk (19), Studies of the origins of lactones, ketones, and aldehydes in UHT products have provided helpful information related to the roles of trace concentrations of individual milk farty acids in the development of UHT and stale flavors, Simple tests to estimate concentrations of the flavor precursors would be useful in quality control, but none is currently available Milk supplies appear to vary in susceptibility to physical changes such as gelation, sediment formation, and fat separation after UHT treat- ment, but causes of the variability have not been explained. Predictive tests for the changes would be helpful in quality control, as well as in clarifying our understanding of the defects. CONCLUSIONS Some broad research areas, with suggestions for specific emphasis, are as follows. 1) Chemis- try and control of flavor defects: cooked flavor, including origins and reactions involved; other heated flavors, especially “UHT-milk” flavor; stale flavor, including identification of cause and origin; bitter and rancid flavors caused by heat resistant enzymes; influence of storage conditions on flavors. 2) Mechanisms and con- trol of physical defects: conditions that influ- ence gelation of milk, concentrated milk, and milk-based products; sediment formation and its relation to gelation; relations to gelation of proteases, and their activators and inhibitors; fat separation, including variability related to milk supply; browning and retarding Maillard reactions, 3) Improvement of processes and systems for UHT processing: uniformity of temperature control; uniformity of residence time, especially in infusion heaters; uniformity of heat treatment of individual particles, especially in injection heaters; temperature dependence of viscosity and heat transfer coefficients at temperatures used for UHT treatments; evaluation of effects of different heating and cooling processes (fouling of equip- ment, effects on products, control of spoilage, ‘optimizing thermal effects, etc.); conditions that influence survival and growth of C. botu- linum in UHT milk; reduction of spoilage attributable to organisms that survive thermalOUR INDUSTRY TODAY processing; inactivation of heat-resistant en- zymes; integration of preservation technologies (eg., heat, radiation, ultrasonics, chemicals). 4) Improved packages and packaging systems: packaging materials; sterilization of packages or materials; assurance of sterility during packa- ging and identifying causes of nonsterility; shelfife of product; foods that contain particu- lates; larger container sizes; faster packaging machines; convenience features, tamper-evident packaging, etc. 5) New and improved products: nutrient losses during storage; foods that con- tain particulates, including processes to assure sterility; foods for fast-food outlets; snack- packed foods; specialty diet foods; formulation to achieve desired properties. 6) Marketing and distribution: consumer attitudes to UHT foods; economic evaluation of UHT processing and distribution, 7) Quality assurance programs: detection of microbial and enzymatic activity; nondestructive evaluation of container integ- rity; methods for prediction of product shelf- life; automation and computerization of quality assurance; detection of residual hydrogen peroxide, Regulations pertaining to UHT processing and aseptic packaging should be reexamined with the objectives of reducing the number of regulatory agencies involved, eliminating con- flicting and overlapping regulations, and gener- ally increasing the efficiency of regulation and inspection. Adoption of the HACCP approach as a key element of regulatory programs should be encouraged. Appropriate representatives of industry, trade associations, and regulatory agencies should be encouraged to appoint a committee or task group to develop recommen- dations for a more rational and efficient regula- tory program, REFERENCES 1 Adams, D. M, 1979, The role of heat resistant bac- terial enzymes in UHT processing. Page 89 in Proc, Int. Conf. UHT Process, and Aseptic Packaging of Milk and Milk Prod. North Carolina State Univ., Raleigh: 2 Anon. 1980. Sterile acceptable milk (SAM): a major energy savings technology. Maryland Agric. Exp. Stn, MP 959. 3 Astrom, A. 1985, Aseptic packaging. Page 139 in IUFOST Symp, Aseptic Process. and Packaging of Foods, Tylosand, Swed, 4 Badings, H. T., JJ.G. van der Pol, and R. Neeter. 1981. 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