Validation of Dry Heat Sterilization Processes

Dry Heat Sterilization is a sterilization process that can be used to terminally sterilize health care products, medical devices, equipment, components or bulk active pharmaceutical ingredients by exposing the items to a temperature of ≥ 160°C for a defined time.

For heat stable items, such as glassware or stainless steel equipment, a dry heat sterilization cycle can be run at 250°C to remove bacterial endotoxins from the items. This process is also referred to as Depyrogenation. Bacterial endotoxins are fever inducing compounds, or pyrogens, that are released when the cell walls of gram negative bacteria such as Escherichia coli are destroyed.

Validation of dry heat sterilization cycle(s) is required by ANSI, AAMI, ISO, USP and the FDA to ensure that all items that are required to be sterile or pyrogen free are able to consistently and reliably be sterilized to reduce the chance of introducing or spreading an infectious microorganism or pyrogen.

Installation Qualification (IQ)

Validation of a dry heat sterilization cycle begins with the execution of the Installation Qualification (IQ) protocol on the equipment (oven, tunnel, or cabinet) which will be used to perform the dry heat sterilization. The IQ protocol verifies and documents that the equipment is installed correctly and meets all of the manufacturer and user requirements. During the execution of the IQ protocol, the equipment drawings, calibration status of critical instruments, instrument and valve information, utility information, and standard operating procedures for the equipment are all confirmed.

Operational Qualification (OQ)

The next step in the validation of a dry heat sterilization cycle is the execution of the Operational Qualification (OQ) protocol of the equipment. The OQ protocol verifies and documents that the equipment is programmed and operating correctly, and is able to meet all of the manufacturer and user requirements. Execution of the OQ protocol involves verifying the parameters/settings (e.g. general system options, cycle length, airflow, sterilization temperature) of the dry heat sterilization cycle(s). It also ensures that the system alarms are operating correctly, that the equipment is functioning properly (e.g. verification that the control system functions as specified by the equipment manufacturer or system interlocks), and that the equipment is able to achieve and maintain the required sterilization conditions during the dry heat sterilization cycle(s).

Performance Qualification (PQ)

The execution of the IQ and OQ protocols covers the validation of the equipment. In order to validate a dry heat sterilization cycle, a Performance Qualification (PQ) protocol must be executed. The PQ demonstrates that the dry heat sterilization cycle(s) can repeatedly achieve the required Sterility Assurance Level (SAL) 1. In order to confirm that the necessary SAL can be reached, the dry heat sterilization cycle must be temperature mapped.

Temperature Mapping

To perform a temperature mapping, data loggers are placed throughout the equipment chamber (distribution data loggers) and the load being sterilized (penetration data loggers). In order to temperature map a depyrogenation cycle it is sometimes necessary to use thermal barriers to protect the data loggers from the extreme heat. All of the data loggers used should have at least a 3 point NIST-traceable calibration performed prior to use.

Kerone have the knowledge and experience needed to help you complete the IQ/OQ/PQ for your dry heat sterilization and depyrogenation equipment and processes. Our experts have your back, so you can rest assured that your dry heat sterilization or depyrogenation cycles are being completed – optimally, reproducibly, and consistently.

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Effect of Drying Characteristics of Garlic

Natural sun drying is one of the most common ways to preserve agricultural product. the most purpose in drying farm manufacture is to reduce its water activity from the harvest level to the safe storage level in order to increase its shelf life. Once the product has been dried, its rate of deterioration because of respiration, insects, and microbial activity and biochemical reactions should diminish resulting in maintenance of quality of the stored product. It does improve bargaining position of the farmer to keep up comparatively constant value of his product. Drying reduces post-harvest losses and transportation prices since most of the water are taken out from the product throughout the drying method. In India, sun drying is the most typically used technique to dry the agricultural material like grains, fruits and vegetables. In sun drying, the garlic is spread in a very skinny layer on the bottom and exposed on to solar radiation, ambient temperature, wind velocity, relative humidity, initial moisture content, absorptive, exposure time and mass of product per unit exposed area.

Garlic is a bulbous perennial vegetable spice. The bulb is composed of pungent bolblets, commonly known as cloves. Garlic is a semi-perishable product. Due to lack of suitable storage and transportation facilities, about 30% of fresh crop is wasted by respiration and microbial spoilage. At times of shortages, India imports garlic of Chinese origin from Taiwan or via Nepal. Fresh garlic, dehydrated garlic flakes, dehydrated garlic powder and garlic oil is exported from India. India was once a leader in this field but is losing out to China in the overseas market. China has an edge over India in terms of both quality and quantity.

Food drying is one of the oldest methods of preserving food for later use. Food drying is a very simple, ancient skill. It is one of the most accessible and hence the most widespread processing technology. Sun drying of fruits and vegetables is still practiced largely unchanged from ancient times. Traditional sun drying takes place by storing the product under direct sunlight. Sun drying is only possible in areas where, in an average year, the weather allows foods to be dried immediately after harvest. The main advantages of sun drying are low capital and operating costs and the fact that little expertise is required. The main disadvantages of this method are as follows: contamination, theft or damage by birds, rats or insects; slow or intermittent drying and no protection from rain or dew that wets the product, encourages mould growth and may result in a relatively high final moisture content; low and variable quality of products due to over-or under drying; large areas of land needed for the shallow layers of food; laborious since the crop must be turned, moved if it rains; direct exposure to sunlight reduces the quality (colour and vitamin content) of some fruits and vegetables. Moreover, since sun drying depends on uncontrolled factors, production of uniform and standard products is not expected. The quality of sun dried foods can be improved by reducing the size of pieces to achieve faster drying and by drying on raised platforms, covered with cloth or netting to protect against insects and animals. In open sun drying, there is a considerable loss due to various reasons such as rodents, birds, insects and microorganisms. The unexpected rain or storm further worsens the situation. Further, over drying, insufficient drying, contamination by foreign material like dust dirt, insects, and micro-organism as well discolouring by UV radiation are characteristic for open sun drying. In general, open sun drying does not fulfil the quality standards and therefore it cannot be sold in the international market.

The major quality issues faced throughout garlic drying loss of flavour, discoloration and poor rehydration characteristics of the dried garlics. Garlic flavour and colour are usually perceived as important quality attributes. In drying, diffusivity is employed to indicate the flow of moisture from the material. in the filling rate amount of drying moisture removed is controlled mainly by molecular diffusion. Diffusivity is influenced by shrinkage, case hardening throughout drying, moisture content and temperature of the material.

Methods of Drying:

 Hot air drying

Hot-air drying of garlic slices in a common fixed bed method is unfortunately not suitable due to a significant decrease in the quality of dried product related to the fresh one. Applying high temperature (about 60°C) in a fixed bed drying causes an increase in drying period, energy consumption, color degradation and mass transfer.

Solar and Open sun drying

Recent efforts to enhance on sun drying have led to solar drying. Solar drying additionally uses the sun because the heat source. A foil surface within the dehydrator helps to extend the temperature. Ventilation speeds up the drying time. Shorter drying times reduce the risks of food spoilage or mold growth. it’s a complex operation involving heat and mass transfer which can cause changes in product quality. Physical changes which will occur include shrinkage, puffing and crystallization.

Infra-Red drying

Microwave and infrared (IR) drying are studied for achieving quick drying and reducing quality loss of fruits and vegetables. a mixture of hot air and microwave drying of osmotic dehydrated blueberries had similar or higher product quality compared with freeze-dried product with a lot of reduced drying time.

Fluidized bed drying

Thin layer drying properties of high moisture garlic sheets under semi fluidized and fluidized bed conditions with high initial moisture content (about 154.26% d.b.) were studied. Air temperatures of 50, 60, 70 and 80°C were applied to garlic samples. Among the applied models, Page model was the best to predict the thin layer drying behavior of garlic sheets.

Dried garlic Products

Garlic Powder: In Asian country thanks to lack of appropriate storage, transport and process facilities, significant losses are incurred both in terms of quality and quantity thanks to respiration, transpiration and microbiological spoilage. Through garlic is made abundantly and consumed as such, little efforts have so far been made to supply dehydrated garlic and garlic powder.

Conclusion

To obtain the dehydrated product of prime quality, the drying method should be specified it allows effective retention of colour appearance, flavour, taste and nutritive value, comparable to recent vegetables. The technique of drying is perhaps the oldest technique of food preservation practiced by human race for the extension of food period. The utilization of artificial drying to preserve agricultural commodities is increasing, making a requirement for a lot of fast drying techniques and ways that reduce the big quantity of energy needed in drying processes. Just in case of garlic is an antioxidant product used for many medicative purposes. New and innovation techniques that increase drying rates and enhance dried garlic quality are receiving substantial attention.

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Continuous Granulation and Drying Techniques Trends

The term “continuous” is applied to all production or manufacturing processes that run with a continuous flow. With that definition, continuous processing of solid dosage products in the pharmaceutical industry means starting the process from the synthesis of API to the final packaging of tablets or capsules 24/7 all year-round.

The pharmaceutical industry has been slow to adopt or even consider the concept of continuous processing, even though its value has already been proven in other industries—polymer, food, dairy, electronics, automobile and petrochemical/chemical—which have implemented fully continuous production processes for many years.

The pharmaceutical industry is also dominated by batch processes due to the smaller amounts that must be processed compared to other industries. The small material quantities available during the development stage also dictate the use of a batch process during the design phase of the formulation and manufacturing process, and these same batch-wise processes are often scaled up to production. Batch-processing equipment is the most flexible and convenient to use. There is reluctance from the industry to embrace continuous manufacturing because of the additional capital investment required along with the prospect of the current vast disposition of batch process equipment and staff training that would be required.

Continuous granulation

The granulation aspect is defined as “A unit operation of mechanical process engineering characterised by a combination with a change in particle size using pressure, solvent or binder.”

There are completely different techniques utilized within the industry to produce granulated product depending on the physico-chemical properties of the composition, intended product attributes needed, and therefore the access to the process technology needed to produce the dosage form.

Achieving the vision of continuous manufacturing of solid dosage, where product starting as API and ending up as a finished dosage form via wet granulation, will not happen immediately. To start you need to ensure that the necessary technology and skills are sufficiently available.

Much of the product quality should be achieved by designing an effective process at the design stage and supplemented, as needed, by additional in-process controls, monitoring and end product testing.

Many unit operations are intrinsically continuous and are well understood. For all remaining unit operations, equipment is accessible. Experiences with continuous wet granulation are positive. Opportunities to a adopt continuous method exist and may depend upon QbD approach, for that it’ll need a lot of advanced management systems with simple and more complex PATs. It should be realised that not all product or processes are manufactured with continuous granulation approach. each API will have to be evaluated for its capability to be a candidate for continuous granulation and a pertinent method will have to be developed for it.

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Drying System Temperature Control for a Large Format Textile Printer

In the digital giant format textile business, the drying system is one amongst the most vital subsystems within the printer. The objectives of this method are dry the media enough in order that there’s no transfer between the rolled media and also the following one, and to produce a hot air (airflow and temperature) within the print zone to reduce bleed and coalescence. And one amongst the most critical parameters within the dryers is that the management of the temperature uniformity on the scan axis within the print zone. A fine control of the temperature uniformity will increase the media versatility by enabling lower temperatures within the print zone whereas drying and increase the throughout capability level. Also improves bleed and coalescence and alternative image quality artifacts. In many printers, the drying system is based on convection with a hot chamber flowing hot air through several diffusers to the print zone.

In those drying systems, in most of the cases, the temperature uniformity can be achieved by separating the chamber in several modules. Each module controlled independently.

The main drawback resolved by this invention is that the improvement of the temperature uniformity in each the hot chamber and therefore the print zone on the scan axis. Within the dryer convection systems (that are using many local fan/heaters assemblies on the chamber) it’s difficult to confirm the uniform temperature and pressure. but if the variability of the temperature may be controlled and reduced then the temperature may be reduced (allowing wider media ranges) or the drying capability may be improved.

Prior solutions and their disadvantages to improve the temperature uniformity in the convective dryers, in the hot chambers, are:

Use a unique hot chamber along the scan axis:

There is a unique chamber and many fan/heaters assemblies on the scan axis and the temperature sensors may be implemented or not.

These are the main disadvantages of this configuration:

  • Large variability of temperature along the hot chamber and the print zone
  • When there is no temperature sensor in the chamber, the air temperature cannot be controlled. In some printers, the heater is only used to warm‐up the printer when the external temperatures are low.

Use several hot multi‐chambers along the scan axis:

There are several chambers (depending on the printer width) with a fan/heater/temperature sensor in each chamber. Each module can control de air temperature with temperature sensor. The main disadvantage of this configuration is the cost implied and the overall complexity. Each module required each hardware supports and PCA controls.

Increase the number of fans/heaters in a unique chamber along the scan axis:

Another option can be used to improve the temperature uniformity can be increase the numbers of fans/heaters assemblies along the scan axis. The more fan/heaters assemblies, better temperature uniformity can be got.

The main disadvantage of this configuration is the cost of the components

  • Fan
  • Heater
  • Temperature sensors

Advantages of the solution over what has been done before:

  • As stated before, this solution offers much better temperature uniformity along the scan axis hot chamber and reducing the cost and the complexity of the drying system.
  • Another important advantage is that, since the temperature sensor is not located in the hot airflow, the measurement variability is much accurate.
  • And another important advantage of the solution is that the whole assembly (fan + heater + air distributor + temperature sensor) serviceability is very good. All the components of the Drying System can be replaced very easily by service or even trained customers.

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Microwave Heating Systems for Sintering of Ceramics

Processing of ceramic materials has also a strong impact in the quality of the consolidated body, as it plays a key role in the resulting microstructure and, as a consequence, in its final properties. Advanced ceramic materials are commonly processed as powders and densified via a high-temperature process. Traditional processing techniques include hot isostatic pressing, mold casting, and sintering in conventional ovens. As ceramics require very high processing temperatures compared to metals and polymers, these processes tend to be very energy intensive and result in higher production costs to the manufacturers. Therefore, new technologies known as nonconventional sintering techniques, such as microwave technology, are being developed in order to reduce energy consumption, while maintaining or even improving the characteristics of the resulting ceramic material. This novel and innovative technology aims at helping industrial sectors lower their production costs and, at the same time, lessen their environmental impact. On the other hand, it is interesting and necessary to know and explore the basic principles of microwaves to advance in the development of materials that demand, every day more, the different industrial sectors.

High-temperature processes are required to consolidate ceramic powders, such as zirconia, alumina, silicon carbide, and so on, in order to obtain full densification of the material. Sintering is a common material processing technique aimed at fulfilling this task. The fundamental principle behind sintering consists in the thermal activation of mass transfer mechanisms when exposing a powder compact, known as a “green” body, to a high-temperature process, at a dwell temperature below the melting point of the material. The main purpose of sintering is to obtain a dense and resistant body with properties as close as possible to those of a theoretical, fully dense solid. However, in some cases, sintering can also be employed to adjust some of the properties based on the performance requirements of the material by not reaching full consolidation, such as in porous materials.

Two main types of sintering can be identified based on the nature of the process: liquid phase and solid phase. Even though the term liquid phase may suggest exceeding the melting point of the material, it is used to describe the addition of compounds with significantly lower melting points that aid in the consolidation of the main powder, which is regarded as the matrix phase and provides the main properties of the consolidated body.

The most important advantages of microwave sintering against conventional sintering methods are listed as follows:

  • Shorter sintering time and lower energy consumption;
  • Higher heating rates can be used.
  • Materials with a finer (Nano metric) microstructure with a high degree of densification and enhanced mechanical properties may be obtained due to the densification mechanisms involved;
  • Flexible due to the possibility of processing near-net-shape materials.

Microwaves have been used since the 1960s for heating purposes, particularly for food- and water-based products. Industrially, the use of microwave energy has become increasingly important because it represents an alternative to traditional with high-temperature processes. For example, so far, it has been employed in wood drying, resin curing, and polymer synthesis. The growing interest in industrial microwave heating is due mostly to the reduction of production costs resulting from lower energy consumption and shorter processing times.

Microwave sintering is considered a relatively new ceramic material processing technique that differs significantly from conventional sintering methods due to the nature of the heat transfer mechanisms involved. Hence, microwave sintering is classified as a non-conventional sintering technique. This method presents itself as a fast, economical, and flexible processing tool. Some of the most important advantages against conventional sintering systems include lower energy consumption and production costs, reduction of processing times, higher heating rates, and, in some cases, even an improvement in the physical properties of the consolidated material

In a general sense, microwave sintering increases the densification of the material at lower dwell temperatures when compared to conventional sintering, employing shorter times and less energy, and resulting in an improvement of the microstructure and mechanical properties.

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Drying Evaluation of Green Coconut Pulp

The world production of coconut (Cocos nucifera L.) was about 60 million tons in 2008 [1] — 85% in Asia, 8.5% in America, 2.9% in Africa and 3.2% in Oceania. Some of the coconut-based products are coconut oil, coconut water, copra and shredded coconut. Coconut products can also be found in beverages, cosmetic and toiletries products. The fresh or industrialized coconut water is much appreciated as a natural isotonic in Brazil. Its demand reaches 1.4% of soft drink market. A serious environmental problem has come up due to the inappropriate disposal of the husks. It is estimated that 350 million liters of green coconut water are consumed in Brazil every year and this consumption produces approximately 2 million tons of green coconut husk. 70% of the waste generated in Brazilian coastal urban centers is green coconut husk.

Green coconut husk is an excellent bio-material for the adsorption of Indigo Blue from textile industries. Other studies showed that the young pulp, in its very early maturation stage, presents interesting properties to be used as ingredient in ice cream, bread and cake.

Drying is another possibility to preserve the pulp that is discarded inside the husk. There are studies of drying coconut pulp in a CD and in a conventional fluidized bed. The low efficiency of CD and the lack of uniformity of the material, which favors channeling and agglomeration under conventional fluidization, led to the innovative-pulsed fluidization technique. Product quality was evaluated by Aw, enzymatic activity, color (parameter L), moisture content and texture analyses and the results were related to the process variables. Mathematical modeling of drying curves was done too.

Material and Methods :

Cabinet drying and pulsed fluid bed drying were performed to determine drying curves at 60, 70 and 80 °C. The initial and final Aw, moisture content and product luminosity, along with the visual aspect, were the parameters used to choose the best drying conditions. After the temperature was established, the variation of luminosity, enzymatic activity, Aw and texture were determined throughout the drying process.

Extraction of coconut pulp :

The green coconut used in this work was the Nana Griff kind (Dwarf Coconut Palm), grown in the Brazilian Northeast. Coconuts were sanitized with NaClO, and coconut water was drained. The husks were cut to have the pulp extracted. The pulp was then vacuum packed, frozen and kept at -20 °C until use. The analyses were performed at least in triplicate.

Sampling :

Due to the lack of product homogeneity, the samples for the analyses were obtained by fragmentation of various pieces of pulp, thus compensating for heterogeneity.

Moisture Content :

The moisture content was determined as described in A.O.A.C.

Luminosity :

The color analyses were performed using the colorimeter COLOR EYE XTH calibrated with 10 degrees of observation angle. The parameter used was the luminosity (L*). Browning of the material was inferred by the decrease in luminosity.

Fat Content :

Coconut pulp samples were ground in mixer, dehydrated and the fat content was determined by A.O.A.C.

Enzymatic Activity :

10 g of pulp were homogenized with 100 mL of 5% polyvinylpolypyrrolidone (PVPP) suspension. The homogenate was centrifuged at 1600×g for 15 minutes at 4 °C centrifuge. Polyphenoloxidase (PPO) and peroxidase (POD) activities were determined by spectrophotometric method using a UV-VIS spectrophotometer (Varian Cary 100). The PPO activity unit was defined as an increase of 0.001 min-1‡ ǻ$420 min-1‡ (ml sample) -1, using catechol as substrate. One POD activity unit was defined as the amount of enzyme capable of producing the conversion of 1 mmol of guaiacol per second under the test conditions.

Water Activity :

Water activity was measured by a hygrometer at 25 °C

Texture Analyses :

A Texture Analyzer with a 5-mm stainless steel cylindrical probe, in a load cell of 25 kg was used. A sample was placed on a hollow planar base and the force was applied by the probe at the constant speed of 1.0 mm.s-1 and 3 mm of penetration. Force deformation data were recorded. The maximum force and the number of peaks indicated the crispness.

Cabinet Dryer (CD) :

Cabinet Dryer was manufactured by Armfield, UK (Figure 1). It consists of a 28 cm × 28 cm square duct and a fan (a) with adjustable speed, which blows the air through electric resistances (b), controlled by a PID device. A 5.0 × 102 g layer of material was spread over the surfaces of two 20 cm × 20 cm trays in the chamber. The trays were held by an analytical scale (c) enabling mass measuring during drying. Air velocity was 2.1 m-s -1 in all tests.

Pulsed Fluid Bed Dryer (PFB) :

The gas distribution system is the distinctive feature of the PFB equipment. In the experimental set-up used in this work, the distribution of airflow is provided by two disks installed upstream of the drying chamber, on opposite sides of the gas distribution chamber. These disks are synchronized for they share a common shaft.

In case of high production yield, the recommended equipment is PFB dryer because it has great productivity by allowing the drying of large amounts of green coconut pulp. The results showed that the dehydration is a good way to make the green coconut pulp useful, increasing its shelf life and providing a snack-like product.

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Combined treatments of blanching and dehydration

The blanching method is utilized to scald vegetables in boiling water or steam for a particular quantity of your time. It stops enzyme actions which may cause a loss of flavor, color, and texture once the food is frozen or dehydrated.

It’s also called parboiling.

Blanching helps to rid of the surface of food from dirt and organisms, it brightens the color and helps retain vitamins. Some vegetables are extremely fibrous and taking the time to blanch them wilts, or softens them, in order that they can dry quicker or be easier to package for freezing.

Blanching time is crucial and varies with the vegetable and size. Under-blanching vegetables will stimulate their enzymes and is worse than no blanching.

When water blanching, be careful and use the suggested times. Overdoing the blanching time can cause loss of flavor, color, vitamins, and minerals; therefore you’ll primarily transfer all the nutrients from the food to the boiling water.

These vegetables can continuously need blanching. you should only use vegetables that are in wonderful condition. With larger vegetables, prepare to the size you wish first, and then blanch.

Once you’ve completed the blanching method (including the ice water bath), food can be stored within the deep freezer or processed in a dehydrator.

BOILING WATER BLANCHING

To make blanching easy, consider creating a blanching station to make the process go a bit faster. Begin by making an assembly line from your stovetop to your sink.

STEAM BLANCHING

Heating in steam is an alternate to water bath blanching and is even suggested for a couple of vegetables. Try this technique for broccoli, pumpkin, sweet potatoes, and winter squash, which is able to help them, keep their texture higher. Steam blanching isn’t faster than boiling water blanching, in fact, takes regarding 1½ times longer to urge the vegetables to the proper state.

MICROWAVE BLANCHING

Microwave blanching might not be effective since research shows that some enzymes might not be inactivated. This might lead to off-flavors and loss of texture and color with the finished product. On the opposite hand, there seems to be some vitamin retention once using this technique, since microwaving doesn’t fully submerge the food into boiling water which may take away a part of the nutrients.

If you want to try the microwave blanching method, be sure to work in small batches and use the directions for your specific microwave oven. Microwave blanching will not save your time or use less energy.

While blanching, a few nutrients are lost into the water. But don’t waste it! You can still use that water in other ways!

  • Cook rice, couscous, or quinoa;
  • Use as the beginning of a stock or soup base;
  • Use as the water in any recipe;
  • Water plants or garden after it has cooled.

In some cases, blanching will really help with thick skinned berries by breaking the skins to make dehydrating a bit quicker. Whereas you can also freeze or cut, blanching is a good way to do it for a large amount.

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Applications of sand roasting and baking in the preparation of snacks

In India, the sand roasting technique is widely used by street food vendors, villagers and cottage industries for making various value-added food products from different cereals, millets and legumes. The traditionally produced sand-roasted products are commonly utilized as ready to eat snacks or for the preparation of various other snacks.

The techniques of sand roasting and baking are gaining importance as cheap, effective, oil-free, healthier ways of cooking. However, further studies are needed on micronutrient availability and functional food development for community nutritional disorders. Also, the residual silica levels and difficult working environment mandates the development of energy-efficient and high-output-orientated technologies such as continuous, microwave, and fluidized bed roasters.

In terms of health benefits, minimally processed foods are better than the processed foods. Among the minimal processes, sand roasting is a traditional, rapid food processing method which utilizes dry heat for a shorter span of time. In this high-temperature short-time treatment, the heat energy is transferred via conduction. The sand roasting causes faster dehydration, characteristic thermal and chemical reactions, and reduction in water activity of the grains. During roasting, the far infrared rays produced from the sand penetrate the grains and aid in breaking down of the starch, protein, and fats in the grains.

The cereals belong to the family Graminaceae and include rice, wheat, maize, barley, oat, and rye. They are the important carbohydrate resources, in addition to minerals, dietary fiber, and bioactive compounds. The different methods such as conventional dry heating, sand roasting, hot-air popping, gun puffing, microwave heating are used for producing value-added cereals with distinctive aroma and taste.

Sand Roasting of Rice

Among the cereal crops, rice occupies a key position as a major cereal crop and staple food in human nutrition due to its texture, taste, and nutritional qualities. There are vast number of paddy varieties grown in different states of India which are suited for raw milling, parboiling, and value-added rice products. In India, around 10% of the production is used for making value-added rice products such as popped, puffed, and flaked rice.

Popped Rice

It is known as pelalu, khoi, etc. in various Indian languages. It is a traditional value-added product with high cold water swelling capacity originated from raw paddy; arising from high starch gelatinization and low retro gradation. It is prepared directly by high-temperature short-time treatment from the moisture-adjusted raw paddy by sand roasting in a pan at a temperature of 150–250 °C for 25–45 s.

Puffed Rice

It is known as maramaralu, murmura, murra, muri, puri, borugulu, mandakki, kallepuri, etc. in various Indian languages. It is one of the popular, common, oldest minimally processed food items especially used as snack, ready to eat breakfast cereal, infant food, etc. in India. It is also distributed as prasadam to devotees in temples and gurudwaras. It is mostly produced in home or cottage industries by skilled artisans using the cheaply available local material, sand as a heat transfer medium for the uniform distribution of temperature among the grains.

Flaked Rice

It is also known as rice flakes, parched rice, flattened rice, and beaten rice in English and atukuluavalakki, aval, pohachura, chira, chiwada, etc. in various Indian languages. It is one of the oldest traditional rice product which is consumed as a cereal breakfast and sweet or salty snack either by toasting, roasting, frying, spicing, or soaking in water, milk, and seasoning with vegetables and spices in India. It is a flattened, carbohydrate rich, edible, precooked, rice product produced by soaking the paddy, sand roasting, and flattening.

Sand Roasting of Maize

Popcorn is the most important, popular commercial snack produced worldwide from corn. It is available in small packs, coated with various ingredients such as hydrogenated oil, sugar syrup, salt, β-carotene, favors, etc. for improving the sensory quality. There are various corn-popping methods are available including conventional sand roasting, gun popping, hot-air popping, and microwave popping. Among which, the microwave and pressure cooker popping are the most popular methods at households due to energy-efficiency and short time. The popping of maize depends on corn variety; kernel size, shape, and density; pericarp thickness; moisture content (11-16%); popping temperature; and popping method.

There are many more products and different types of sand roasting techniques:

  • Sand roasting of barley
  • Sand roasting of oats and wheat
  • Sand roasting of millets
  • Sand roasting of groundnut fruits and seed kernels
  • Sand roasting of chickpea, cowpea, pea, black gram, and kidney beans
  • Sand roasting of other food items
  • Sand baking of vegetables, eggs, meat, and cake

The limitations of the sand roasting technique are lack of temperature control, uneven temperature distribution and sand contamination in the final products. The sand roasting method is energy inefficient, tedious, manual in operation involving continuous hand stirring, sometimes unhygienic, and limited by low output. The workers are prone to direct influence of heat, flame, and smoke originated from the commonly used fuels such as crop and agro-industrial residues, wood, charcoal, kerosene, and gas. Thus, the current traditional and industrial sand roasting method necessitates the development an alternate technology for production of value-added cereal and legume food products which is low-cost, energy-efficient, effective, high-output-orientated with no exposure of the food products to impurities. For example, continuous, microwave, and fluidized bed roasters save cost, reduces the manual labor, enhances productivity, and maintains uniformity in roasted products. In addition to consumer satisfaction, it also provides temperature range optimization, even heat distribution within the heating chamber and food grains and applicability to wide range of materials.

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A Model-Based Methodology for Spray-Drying Process Development

Solid amorphous dispersions are frequently used to improve the solubility and, thus, the bioavailability of poorly soluble active pharmaceutical ingredients (APIs). Spray-drying, a well-characterized pharmaceutical unit operation is ideally suited to producing solid amorphous dispersions due to its rapid drying kinetics. This paper describes a novel flowchart methodology based on fundamental engineering models and state-of-the-art process characterization techniques that ensure that spray-drying process development and scale-up are efficient and require minimal time and API. This methodology offers substantive advantages over traditional process-development methods, which are often empirical and require large quantities of API and long development times. The methodology is used from early formulation-screening activities (involving milligrams of API) through process development and scale-up for early clinical supplies (involving kilograms of API) to commercial manufacturing (involving metric tons of API). It has been used to progress numerous spray-dried dispersion formulations, increasing bioavailability of formulations at preclinical through commercial scales.

Spray-drying is a widely used unit operation for pharmaceutical applications. In addition to its use in preparing solid amorphous spray-dried dispersions (SDDs), spray-drying is used in excipient manufacture, pulmonary and bio therapeutic particle engineering, the drying of crystalline active pharmaceutical ingredients (APIs), and encapsulation.

In common practice, spray-drying process development is often empirical and is experimentally driven. Traditional methods often use an iterative design of experiments (DOE) or statistical treatment of the process parameters and resulting product attributes. This is often a time-intensive exercise, requiring large quantities of API, and the resulting process is often not well understood or sufficiently robust.

The spray-drying process is a well-established unit operation in the pharmaceutical industry. To manufacture an SDD, a spray solution—which consists of API and polymer dissolved in a common solvent—is delivered to an atomizer inside a spray-drying chamber concurrently with a hot drying gas. Organic solvents are typically used to produce SDDs because the API tends to be poorly water-soluble. Nitrogen drying gas is employed to provide an inert processing atmosphere when processing organic solvents. The spray solution is atomized into droplets using a spray nozzle. Many different types of spray nozzles can be used including two-fluid, ultrasonic, rotary, and pressure (or hydraulic) nozzles. Pressure nozzles are often preferred due to their simplicity, scalability, and ease of droplet-size tuning. When the spray-solution droplets contact the hot drying gas, the solvent in the droplets evaporates, leaving dried SDD particles entrained in the drying gas that exits the drying chamber. These particles are collected and then separated from the gas stream, usually by a cyclone separator.

Based upon an evaluation of the physicochemical properties of the API, several initial formulations (generally, two to four) are selected and screened in this step. A screening-scale spray dryer designed for maximizing yields from SDD batches of <100 mg is used. This dryer is not designed to replicate optimized bulk powder properties (e.g., particle size, density) of larger-scale spray dryers, but rather is used to match physicochemical properties for fast, efficient formulation-screening studies. Analogous to the process-development flowchart methodology, a formulation selection flowchart, comprising predictive physical-stability models, rapid chemical-stability screens, and bio relevant in vitro performance tests is key to selecting a lead SDD polymer and drug-to-polymer ratio. For the sake of brevity, these will not be addressed in this paper.

After a robust formulation has been identified, equipment-related and formulation-related process constraints are identified, resulting in definition of the drying-gas flow rate (M gas) and drying-gas inlet temperature (T in).

The thermodynamic operating space described above defines the process based upon near-equilibrium assumptions and does not account for kinetic limitations such as the drying of large droplets or increased drying resistance due to film formation at the droplet surface. Drying kinetics of single droplets can be studied experimentally, but the information provided—while useful—does not account for the actual conditions in the spray dryer such as droplet velocity and momentum exchange between the droplets and the drying gas.

Many aspects of this approach can be directly translated to other atomization/evaporative processes, such tablet-coating and fluid-bed processes. A similar strategy can also be applied to many other pharmaceutical-processing unit operations.

We at KERONE have a team of experts to help you with your need for spray drying in various products range from our wide experience.

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