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The document discusses cold chain management for perishable goods such as food and pharmaceuticals. It defines the cold chain as the transport and storage of temperature-controlled perishables from production to the consumer. Proper cold chain management is important to ensure the shelf life and quality of these goods. Validation of the cold chain involves analyzing, measuring, controlling and documenting every step to ensure temperature requirements are consistently met during storage and distribution.

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0% found this document useful (0 votes)
252 views15 pages

C C C C C C C CCCCCCCCCCCCCCCCCCCCC CC: CCCCCCCCCCCCC

The document discusses cold chain management for perishable goods such as food and pharmaceuticals. It defines the cold chain as the transport and storage of temperature-controlled perishables from production to the consumer. Proper cold chain management is important to ensure the shelf life and quality of these goods. Validation of the cold chain involves analyzing, measuring, controlling and documenting every step to ensure temperature requirements are consistently met during storage and distribution.

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Velani Gonsalves
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© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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An assignment On Cold chain management .

INTRODUCTION

The cold chain is generally considered as the transport and storage chain between the initial production and the final consumer of temperature-controlled perishable goods. This is not a complete definition, as there are other items carried under temperature control, for example works of art. For the purposes of this paper, only the transport and storage of perishable foodstuffs and pharmaceuticals will be considered. There are many types of cold chain. They may be categorized by carriage mode, by commodity, or by location and duration of transport. Air freight is generally limited to goods at chilled or ambient temperatures. Sea containers are universal in their application. Refrigerated ships carry bulk commodities in their holds, though increasingly these ships also carry containers. International land transport by road and/or rail is able to carry anything. Local distribution generally excludes the movement of bulk frozen goods. At the present time there are approximately 1300 specialized refrigerated cargo ships, 80 000 refrigerated railcars, 650 000 refrigerated containers and 1.2 million refrigerated trucks in use worldwide. They carry vast amounts of foodstuffs and other perishables and mostly do so very successfully. Storage is an important part of the overall cold chain. It has been reported by one company that, in the transport of pharmaceuticals during the last five years, critical or major problems arising in storage are more than four times as frequent as problems arising in transport. This emphasizes the point that cold chains should always be considered as a whole, if reliable results are to be obtained.

THE INDIAN FOOD PROCESSING INDUSTRY


The Food processing industry has an important role to play in linking the farmers to the final consumers in the domestic as well as the international markets. Food processing combined with marketing has the potential of solving the basic problems of agricultural surpluses, wastages, rural jobs, and better remuneration to the growers. In the next ten years, food production is expected to double. These produces, if processed and marketed smartly, can make India a leading food supplier of the world. India with a population of 1.08 billion (growing at about 1.7 % per annum) provides a large and growing market for food products. Food products are the single largest component of private consumption expenditure, accounting for as much as 49% of the total spending. Furthermore, the upward mobility of income classes and increasing need for convenience and hygiene is driving demand for (a) perishables and non food staples and (b) processed foods. Also, eating out is a booming practice in urban India and processed foods are accepted as alternative to the home cooked food because of the convenience it offers. Also, with the globalization of trade and availability of high speed logistics, food retailers in developed countries are sourcing an year-round supply of fruits and vegetables from developing countries. Thus, both for local consumption as well for export there is a year round opportunity for fruits and vegetables, meat and poultry products and ready to eat processed foods. The processed food industry should introduce innovative new products of high quality at low cost in small package sizes in ready to eat format to cash on this booming

opportunity. HLL, ITC, MTR and others have introduced some innovative heat and eat dishes with reasonably good packaging. But there is lots of manual handling and hence food hygiene and quality are suspect. Multinational companies have entered the food value chain in India, Cargill and Conagra in agri-inputs, Tropicana in food processing and Metro in wholesaling. Local companies like Dabur, MTR, ITC, Godrej, and Amul are aggressive across the value chain. Multiple restaurant chains such as McDonalds, Pizza Hut, Dominos, Coffee day, Qwikys and Saravana Bhavan, and Sagar Chains are growing rapidly. However, the pace is slow in the food sector compared to the other sectors such as IT and Pharma. There are no billion dollar players in India in the food industry where as China and Philippines have several large players with sales exceeding US $ 1 billion.

FOOD SUPPLY CHAIN CLUSTER


Food chain clusters (See Figure1) are formed with the participation of all stake holders such as farmers, seed growers, merchants, transporters, wholesalers, retailers, financial institutions, and insurance companies. Information sharing is essential for generating the efficiencies. The Internet and mobile communications are used to enable information and financial transfer between the stake holders. Also, recent advances in RFID technology will have tremendous impact in the management of the food chain particularly for source identification and tracking and also in providing supply chain visibility.

The Food Supply chain cluster

In advanced countries, the retailers (Walmart, Tesco, etc) have become the Channel Masters of food supply chain taking over from the food manufacturers. In India, with no superstores, no economies of scale, too many intermediaries, there is a vacuum, meaning there is no real channel master managing the supply demand situation and coordinating the supply chain and managing the logistical activities. This provides a tremendous opportunity for smart players to enter a growing market with a high potential of retail FDI. But one needs to remember that the infrastructure capital outlays are high and the returns are long term. Also there are various risks associated with owning a cold chain. some of these include country risk, monsoon risk, crop or raw material supply failures due to pests, diseases, etc., partner risk, and numerous others In India, there are very few large food manufacturers. Amul, Ruchi Soya, Nestle, MTR, ITC, Dabur, Britannia, HLLs food and beverages section, beverage companies such as Coke and Pepsi are some of the big names. In poultry Godrej Agrovet, Suguna, Pioneer and Venkateswara hatcheries are some of the companies integrating operation s end to end from breeding to ready to eat chicken foods. High taxes on processed food, high import duties, nascent contract forming, make the profitability a big issue in India. There are several regulatory changes that need to be made all along the supply chain so that they are consistent and mutually reinforcing.

COLD CHAIN
A cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life of products such as fresh agricultural produce, frozen food, photographic film, chemicals and pharmaceutical drugs

Uses

Cold chains are common in the food and pharmaceutical industries and also some chemical shipments. One common temperature range for a cold chain in pharmaceutical industries is 2 to 8 C. but the specific temperature (and time at temperature) tolerances depend on the actual product being shipped. This is important in the supply of vaccines to distant clinics in hot climates served by poorly developed transport networks. Disruption of a cold chain due to war may produce consequences similar to the Smallpox outbreaks in the Philippines during the SpanishAmerican war.

Traditionally all historical stability data developed for vaccines was based on the temperature range of 2-8 C. With recent development of biological products by former vaccine developers, biologics has fallen into the same category of storage at 2-8 C due to the nature of the products and the lack of testing these products at wider storage conditions. The cold chain distribution process is an extension of the good manufacturing practice (GMP) environment that all drugs and biological products are required to adhere to, enforced by the various health regulatory bodies. As such, the distribution process must be validated to ensure that there is no negative impact to the safety, efficacy or quality of the drug substance. The GMP environment requires that all processes that might impact the safety, efficacy or quality of the drug substance must be validated, including storage and distribution of the drug substance.

Validation
A cold chain can be managed by a quality management system. It should be analyzed, measured, controlled, documented, and validated. The food industry uses the process of Hazard Analysis and Critical Control Point, HACCP, as a useful tool. Its usage continues into other fields. PDA (Parenteral Drug Association) Technical Report # 39 gives a rough summary of how the cold chain can be validated. The overall approach to validation of a distribution process is by building more and more qualifications on top of each other to get to a validated state. This is done by executing a Component Qualification on the packaging components. Next, an Operational Qualification that demonstrates the process performs at the operational extremes. The final piece is the Performance Qualification that demonstrates that what happens in the real world is within the limits of what was demonstrated in the Operational Qualification limits. The PDA's Technical Report states that a Component Qualification is required to demonstrate that a component can be manufactured to the design criteria of that individual component. This was put into the document because the industry did not understand the principles of Validation; all Validation processes were specific to equipment and not auxiliary processes such as shipping/distribution. Performing thermal testing can also help with validating the cold chain. Certified test labs use environmental chambers to simulate ambient profiles that a package may encounter in the distribution cycle. Thermocouple probes and separate temperature dataloggers

measure temperatures within the product load to determine the response of the package to the test conditions. Replicate testing based on a qualification protocols is used to create a final qualification report that can be used to defend the configuration when audited by regulators. It is normally best to have an individual that understands the principles of Validation, when defending such processes to a Federal Regulatory body of any nation. Cold chains need to be evaluated and controlled:
y

y y y

Carriers and logistics providers can assist shippers. These providers have the technical ability to link with airlines for real time status, generate web-based export documentation and provide electronic tracking. The use of refrigerator trucks, refrigerator cars, reefer ships, reefer containers, and refrigerated warehouses is common. Shipment in insulated shipping containers or other specialised packaging. Temperature data loggers and RFID tags help monitor the temperature history of the truck, warehouse, etc. and the temperature history of the product being shipped. They also can help determine the remaining shelf life. Documentation is critical. Each step of the custody chain needs to follow established protocols and to maintain proper records. Customs delays occur due to inaccurate or incomplete customs paperwork, so basic guidelines for creating a commercial invoice should be followed to ensure the proper verbiage, number of copies, and other details.

During the distribution process one should monitor that process until one builds a sufficient data set that clearly demonstrates the process is in compliance and in a state of control. Each time the process does not conform to the process, the event should be properly documented, investigated and corrected so that the temperature excursion do not occur on future shipments. Thus the process is continually evolving and correcting for anomalies that occur in the process. Eventually the process can evolve into periodic monitoring once sufficient data demonstrates that the process is in a state of control. Any anomaly that occurs once a process is in a state of control will result in the process being invalidated and not in control and result in product withdraw from the market to ensure patient safety. It is necessary to develop an internal documentation system as well as multi-party communication standards and protocols to transfer or create a central repository or hub to track information across the supply chain. These systems would monitor equipment status, product temperature history, and custody chain, etc. These help ensure that a food, pharmaceutical, or vaccine is safe and effective when reaching its intended consumer.

The cold chain and its importance


The cold chain encompasses all the critical steps and processes that foods and other perishable products must undergo in order to maintain their quality. Like any chain, the

cold chain is only as strong as its weakest link. Major limitations experienced by the cold-chain include poor temperature management due to either the lack of, or limitations in, refrigeration, handling, storage, and humidity control. Investment in cold chain infrastructure ultimately leads to a reduction in the level of losses and quality degradation in fresh produce, with overall net positive economic returns.

Return on investment in temperature and relative humidity management


Deficiencies in cold chain management whether due to limitations in refrigeration, improper handling and storage, or inadequate humidity control, can lead to losses in profits as well as in horticultural crops. Overcoming such deficiencies necessitates improvements in methodologies, operations and handling along the chain. Often the level of investment required in overcoming such deficiencies is minimal in comparison to the level of losses sustained over time. A University of California study determined that a one-hour delay in cooling strawberries after harvest resulted in a 10 percent loss due to decay during marketing. The resulting economic loss exceeded the increased cost of expedited handling of the strawberries by more frequent deliveries of harvested fruit to the cooling facility and initiation of forcedair cooling Maintaining The Cold Chain For Perishables Harvest Minimize delays before cooling Cool the product thoroughly as soon as possible Store the product at optimum temperature Practice first in first out rotation Ship to market as soon as possible Use refrigerated loading area Cool truck before loading Load pallets towards the center of the truck Put insulating plastic strips inside door of reefer if truck makes multiple stops Avoid delays during transport Monitor product temperature during transport

Cooling Temporary Storage Transport to Market

Use a refrigerated unloading area Handling at destination Measure product temperature

Move product quickly to the proper storage area Transport to retail markets or foodservice operations in refrigerated trucks Display at proper temperature range Handling at home or foodservice outlet Store product at proper temperature Use the product as soon as possible

A University of California study determined that excess weight loss coupled with color deterioration resulting from delays between harvest and cooling, improper refrigeration temperature and relative humidity control during the shipping of table grapes resulted in a 15 percent loss in the value of that commodity. Resultant monetary losses were greater than the cost of improved management of temperature and RH of the grapes with perforated plastic liners in the boxes and by minimizing delays prior to cooling with humidified, forced air.

HORTICULTURE IN INDIA
FACTS:
India produces 47 million tons of Fruit largest producer in the world. India produces 96 million tons of Vegetables 2nd in the world. Horticulture contributes for over 30% of agri-GDP. Accounts for 41 million hectares of cultivated land Employs close to 150 million people. Traditionally horticulture was grown as filler crop between grains.

FUTURE & GROWTH:


Booming retail sector - trade in 2006 estimated at US$320 Billion Growth expected to US$ 421 Billion in 2010. Organized sector growth at 40-45% annually. Penetration of organized retailing up at 6% in 2006 from 3% in 2003. Capacity to increase penetration in exports and food processing. It is inferred that demand for an efficient & modern supply chains for handling of fresh produce will grow significantly.

EXISTING STATUS OF COLD CHAINS IN INDIA:


Lack of integrated Cold Chain exists. Fragmented cold chain integrity with negligible pre-cooler availability.

Pre-coolers and refrigerated transport still in an experimental stage. Process inefficiencies abound lack of knowledge. Cold storage capacity (20 mn tons) largely caters to storage of potatoes and apples of which potato dominates. Capacities are clustered in 4 states 70% in UP, Uttranchal, W.Bengal & Punjab. No significant capacity addition in cold storage to keep up with the explosive growth in economy. Horticultural business model tutors evacuating produce daily to closest mandi. Financial viability impacted by lack of sustained revenue due to high levels of seasonality of produce. Grid Power failures effect fresh produce shelf life.

The Cold Chain


Cold chain is a logistic system that provides a series of facilities for maintaining ideal storage conditions for perishables from the point of origin to the point of consumption in the food supply chain. The chain needs to start at the farm level (e.g. harvest methods, pre-cooling) and cover up to the consumer level or at least to the retail level. A wellorganized cold chain reduces spoilage, retains the quality of the harvested products and guarantees a cost efficient delivery to the consumer given adequate attention for customer service. The main feature of the chain is that if any of the links is missing or is weak, the whole system fails. The Cold chain logistics infrastructure generally consists of Pre-cooling facilities Cold Storages Refrigerated Carriers Packaging Warehouse and Information Management systems Traceability Financial and Insurance Institutions The temperature controlled supply chains or cold chains are a significant proportion of the retail food market. Fast foods, ready meals and frozen products have increased

market share in recent years. There are several food temperature levels to suit different types of products. Frozen, cold chill, medium chill, and exotic chill are some of the frequently nomenclatures with identified temperature ranges. The range of temperatures is dependent on the products whether it is meat or ice cream or potatoes or bananas. Failure to maintain appropriate temperature regimes through out the product life cycle may shorten the product life or adversely affect its fitness for consumption. Cold chain management involves maintaining appropriate temperature regime when the product travels from the farm in Himachal Pradesh to the consumer in London or New York City. That is why the logistics challenge is formidable in food chains, which is cost conscious industry. There are several governmental regulations in all countries and the responsibility to maintain hygiene and standards falls on the food retailer or manufacturer. The recent developments in electronic tagging could be useful for monitoring the temperatures and also the shelf life of the product.

COLD CHAIN REQUIREMENTS


Produce temperatures All refrigerated produce deteriorates with time at a rate dependent on the temperature of storage. For most frozen goods at normal storage temperatures of -18C or below, maximum times for high-quality storage are appreciably longer than transport times, so there are no special difficulties. Frozen fish requires lower temperatures to achieve this situation. Refrigerated chilled and fresh produce, stored and transported at temperatures between -1.5C and 14C dependent on produce type, frequently has a high quality storage life measured in weeks rather than months, and the relatively slow pace of marine transport frequently requires much closer control of temperature than is achieved in road, rail or air transport if goods are to be carried successfully. Data on storage lives and temperatures show that produce such as oranges and apples are readily transportable by sea, whereas a very short life produce such as watercress could not survive more than a very short sea journey. Many subtropical fruits have lives comparable to the length of time needed to transport them by sea from growing areas to major markets, so special attention to quality of both produce and handling is essential for successful marketing. Many types of chilled and fresh produce have lower temperature limits below which they are damaged. Clearly, for items carried near their freezing points, lower temperatures will give freezing damage, and this is as true for chilled meats as for other more obvious products. For many fruits, there are temperatures well above their freezing points at which low temperature physiological injuries occur. There is a temptation if cargoes are loaded at a high temperature to reduce cargo space temperatures to below carriage temperature to achieve more rapid cooling. This can only be done at the risk of damaging part of the cargo.

It must be remembered that, for many cargoes, safe carriage temperatures depend on the variety as well as the type of produce, and may also depend on growing area and on whether early, main, or late harvested produce is being carried. Also, it may be necessary to mix produce with slightly different temperature requirements, in which case the highest temperature must be chosen, with consequent effects on the storage life of the products requiring lower temperatures. It is essential that the storage characteristics and optimal storage temperature are correctly specified and maintained. Specification is the responsibility of the shipper; temperature maintenance is the responsibility of the carrier. If the shipper specifies the wrong temperature in an obvious way, the carrier will question it, but in less obvious cases the shipper has no reason to over-ride the instructions given. The carriage instructions must be clear and unambiguous. Transport equipment It is essential to use equipment which can do the job. The correct equipment will have good insulation, good temperature control, adequate airflow and refrigeration capacity, and will be well maintained. It will be able to achieve all that is requested in the carriage instructions. In the case of refrigerated containers, it should have been subject to a pre-trip inspection not longer than a month before loading. The operation of transport refrigeration in ships holds, in containers, and in trucks differs, and the shipper would be well advised to be familiar with the equipment to be used. As a rule of thumb, ships should be most reliable because of the size of cargoes they carry, and road vehicles may be most liable to failure as they carry out many journeys often on bad road surfaces

Produce quality At best, refrigerated transport can maintain quality, it cannot improve it. Poor quality produce cannot justify the costs of transportation, and can give the likelihood of an unsuccessful outturn, leading to loss of confidence in the producer. Long-distance transportation should be seen as a means of obtaining premium prices for top quality produce, and never as a means of disposing of second-rate goods for which no local market exists. The quality of produce may be subject to standards and inspections by producer boards or export control boards in the country of origin. It may also be subject to import requirements in the receiving country, details of which must be determined by potential exporters. Pre-shipment handling For fruits and vegetables, this can include application of appropriate post-harvest treatments (e.g. fungicides), short pre-shipment storage times, and avoidance of mechanical damage such as bruising from either sorting or grading machinery or from rough handling of cartons. For frozen goods, the principal requirement is maintenance of temperature throughout all links in the transport chain, without excessive periods lacking refrigeration. Packaging Packaging has to protect produce, so must have adequate strength, if necessary when damp, for the anticipated use. It may also need to incorporate wraps or liners to minimize loss of moisture. However, it must also in the case of respiring produce provide sufficient ventilation to allow heat and respiration products to be removed. Packaging materials must not contain substances likely to

produce taints or odours. Cartons must be of a suitable size and shape to protect the product from movement and also from external pressure. For palletized transport, cartons must be adequately secured to pallets without jeopardizing any air movement designed into the cartons. Successful packaging systems have been developed over the years, and these are frequently more sophisticated in their requirements than is immediately obvious. Changes to such systems should be considered with care.

Pre-cooling For some fruits, such as citrus and banana in marine transport, it is normal practice to load them warm, and cool them during transportation. These are exceptions; generally it is essential to cool fruits to their transport temperature as soon as possible after harvest. For this purpose air-cooling tunnels, hydro-coolers, or vacuum coolers may be used, all of which can extract heat far more rapidly than is possible during transportation. In all transport equipment, cooling rates will be relatively slow, and very dependent on position within the stow. Whilst cooling tunnels may achieve 7/8 cooling times of only a few hours, in transport it is more usual to achieve times of 2 to 6 days. If the cooling demands on the transport equipment are increased excessively due to inadequate pre-cooling, there will be uneven cooling through the cargo, and some areas will be delivered with reduced residual storage life. This loss is due to the loading condition and no amount of care in transport can overcome it. For produce with a high metabolic rate, if it is not yet adequately pre-cooled, the respiratory heat can be so high that correct storage temperatures in transport are unachievable.

Air circulation For frozen goods, air circulation is necessary to remove heat entering from the outside of the storage space through insulated walls. For respiring fresh produce, it is also necessary to remove respiratory heat. For some produce, cooling is also necessary. Transport equipment is designed to provide adequate air circulation in properly packaged and properly stowed cargoes. Wrong packaging or careless stowage can negate this, and can give overall or localised inadequacies of air movement.

Air circulation is also important in retail display open multi-deck cabinets depend on proper air circulation to provide reasonably uniform product temperatures. Temperature control Temperature control for frozen goods is less critical than that for chilled goods. The former require a maximum temperature (e.g. -18C) not to be exceeded, whereas chilled goods on long journeys often require temperatures maintained within a band of 2C or less. In retail display, chilled goods are normally expected to be kept within a 5C band or less. The controllability of transport equipment designed for use with chilled cargoes is of necessity good. However, if equipment primarily designed for frozen goods is used for chilled transport, it may be possible to obtain wider temperature swings or lower temperatures than are desirable. Wide swings mean an appreciable time at higher-than-planned temperatures, with consequent loss of storage life. Low temperatures may mean freezing or damage from chilling injury. Air freshening Air freshening during transport is necessary for cargoes of respiring produce to take away carbon dioxide and ethylene before they reach excessive levels. Air freshening, or fresh air ventilation, requirements are usually clearly specified by shippers, and these requirements should be adhered to. Cross-contamination from other cargo Cross-contamination can be of two types. The most obvious is the transfer of taint or odours from one cargo to another. The other is the transfer of ethylene from produce with high ethylene production rates to ethylene sensitive goods, leading to premature ripening. Carriers usually have clear instructions to prevent inappropriate mixing of cargoes, but care may be necessary to ensure that these instructions are also available to transhipment terminals inland or at ports. Insect infestation Where problems of insect infestation are likely, procedures will have been established by importing countries which may require fumigation or cold treatment of particular produce from some growing areas. It is essential that would-be exporters are aware of requirements of importing countries in this respect.

Journey time Marine transport is generally very reliable, but by the nature of things, breakdowns and storms can sometimes create delays. So also can industrial action, often beyond the control of the carrier. Where such things lead to appreciable delays, damage to more perishable produce can occur.

Time without refrigeration

Goods can be without refrigeration for short periods during land journeys to and from ships, and can occasionally be without refrigeration due to mechanical breakdown of equipment. Breaks in refrigeration of a few hours may be acceptable for many, but not all, produce types. Breaks of a few days are likely to pose problems for all types of produce. Retail sale Following transportation, the cold chain continues through the wholesale handler and the retail store to the customer. In the store, proper equipment sensibly sited and properly used is necessary. Losses at this stage waste all the effort and energy which has been expended earlier in the chain.

The major commodities transported by reefer trucks are:


Cut Flowers and grapes from production location to air port. Majority of floricultureunits owns such vehicles. All Ice cream products. Chocolates Fish and Meat products for domestic and export purpose. All frozen fruits and vegetable products. Pharmaceutical Products. Dry Fruits

Refrigerated Transport
Reefer transportation has been in existence for two decades but has now been considered important with the increase in export of fruits and floriculture produce. Initially, reefer transport system was used for transporting life saving drugs, ice-cream, and frozen food and meat products only. Presently only grapes and flowers are being transported from the production location to the exit point at the seaport or the airport in reefer containers. The flower exporters usually own refrigerated trucks and send flowers to the airports where these are re-loaded on to 3-D containers.

The growth in horticulture exports will be on an average 7.5 % over the next five years. In addition, Maharashtra's sale of produce to other regions of India is expected to grow at 6%. The growth of major metropolitan markets such as Mumbai and New Delhi is expected to reach 8%. This growth will substantially raise demand for transport services and infrastructure and hence the need for reefer trucks.

CONCLUSIONS
India is all set to become the food supplier of the world. It has the cultivable land, all the seasons for production of all varieties of fruits and vegetables, well developed agribusiness system that works in its own way. The business system is tuned to food habits (cooking at home) and convenience (kirana stores) of rural and urban folks of the previous generation. Factors such as rapid growth in the economy, the technological innovations in home appliances such as refrigerators microwave ovens, rise of families with dual incomes and the changing food habits of the population all point to the increasing need for healthy processed food. The supply chain sector is very weak with no process owner and this can spell disaster. The food supply chain needs the attention of the academics, the industry and the Government.

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