Manufacturing and Processing Technology in Food PDF

Manufacturing and Processing Technology in Food  Learning Objectives  At the end of this section the student should understand  The grades of water  The uses of water  The impurities present  The Purification Methods...

Manufacturing and Processing Technology in Food  Learning Objectives  At the end of this section the student should understand  The grades of water  The uses of water  The impurities present  The Purification Methods  The tests to check purity  The other essential Process Utility Systems necessary to support a facility Manufacturing & Processing Technology - Utilities 3  Utilities  Utilities are the process supplements of an industrial plant as power, steam or water.  The most common sources of energy are oil, gas, coal and nuclear energy. The decreasing availability of some sources will necessitate the use of alternative forms of energy.  In the production industry the required power is primarily in the form of electricity, other sources are steam engines, internal- combustion engines and hydraulic turbines.  When a design engineer is setting up the specifications for a new plant, a decision must be based on whether to use purchased power or producing its own power. (if both exist continuous operation is achieved)  The quantity of steam used in a process varies depending on thermal and mechanical requirements and should be generated from whatever fuel is cheapest.  Water Systems  Grades and Uses of water  Impurities in Water  Testing of Water  Purification Systems 5  Water Systems Grades and uses of water 6  Grades of Water  There are three main grades of water used in manufacturing plants.  Each grade has been treated using some technique  Water types include: Potable Water Purified Water Water for Injection (WFI)  Different processes in manufacturing plants require different purities of water.  The water used for each process is specified in the Batch Production Record (BPR). 7  Grades of Water - Potable Water  Types of Water –  Potable water is low grade water and is usually supplied by the municipal water system. Typical uses for potable water are for drinking, plumbing and fire fighting.  The main use for potable water in a plant is to produce purified water and WFI.  Potable water must be purified by a number of treatment processes before it can be used in manufacturing. 8  Grades of Water- Purified Water  Purified water is potable water that has been subjected to further purification by either distillation, deionization or reverse osmosis. 9  Grades of Water- Water for Injection  Water for injection (WFI) is used for the manufacture of sterile products.  This requires the water to be virtually free from any microbial contamination  This makes WFI more difficult to produce than purified water  WFI has the same chemical specifications as purified water but has extra microbial requirements 10  Grades of Water  Water for injection must comply with the following tests  clarity and color of solution  acidity and alkalinity  oxidisable substances  non-volatile matter  pyrogens  bioburden limits  All aqueous injections should be prepared with WFI 11 Water Systems Water Impurities 12  Water Impurities &Treatment Water is widely used in a plant.  It is used for cleaning equipment and also in processing.  Water coming into a plant is normally impure and must be treated before it can be used. Water coming directly into a plant from the local water supply contains impurities. 1  Common water impurities Common water impurities include:  Particulates  Colloids  Ions Organics  Micro-organisms 14  Common water impurities - Particulates Particulates are undissolved solid materials that are in water. These undissolved particles could be dirt, soil or dust depending on where the water has come from. An initial filtration process for example will remove the majority of particulate matter. It is important that the particulates are removed because they are a source of contamination 15  Common water impurities - Colloids Colloids are very small undissolved materials.  They are similar to particulates but they remain suspended in the water.  Colloids are too small to be seen by the naked eye.  They can be detected by shining light, which will be reflected by the small particles, on a water sample.  This reflection effect is called the Tyndall effect.  Colloids must be removed from the water, as they are a source of contamination in reaction processes. 16  Common water impurities - Ions Ions are charged materials, dissolved in water. If a water sample has a high ion concentration, it is usually an indication that the water has a high metal content. Metals, such as lead, can have harmful side-effects to humans. They are not broken down by the body and therefore can accumulate in the body’s tissue. Unwanted ions, present in water, can also affect the manufacturing process and lead to impurities being present in the final API. Calcium and magnesium are metal ions, which if present in high concentrations in water cause a condition called “hard water”.  If these ions are not removed the hard water will cause scale formation on equipment and could block pipelines. 1  Common water impurities - Organic Contaminants Organic contaminants are classified as any material that contains carbon. Typical organics could include pesticides or food residues. Usually all organic material is removed by the local treatment facility. The presence of organic contamination creates a food source for bacteria to multiply and therefore increases the risk of microbial contamination of the final product. 18  Common water impurities – Micro-organisms Micro-organisms are the smallest of all living organisms, which can only be seen clearly under a microscope. Micro-organisms are found in all domestic water supplies. The quantity and types of micro-organisms must be controlled before the water can be used in some plants. 19  Common water impurities – Micro-organisms If the contaminated water is used in a processing step, the micro-organisms could end up in the final product. This can have serious implications for the patient. Micro-organisms must be removed or reduced to a specific safe level, before they can be used in the process. 20 Water Systems Water Testing 21  Water Testing  After the plant water has been treated, it must be sampled and tested to ensure it meets the correct quality specifications.  The main checks and tests that an operator could perform are:  Conductivity  pH  Other important tests carried out by the laboratory include:  Bacterial Counts  Total Organic Carbon (TOC)  Heavy Metals  Endotoxin 22  Nitrates  Water Testing Conductivity is a measure of the quantity of ions in a water sample. If the conductivity of the water is very high this indicates a quality problem with the water, which is usually caused by the presence of ions such as calcium and magnesium. The conductivity is measured by a conductivity probe within the water storage vessel or alternatively a portable conductivity meter can measure small samples taken from the vessel. 23  Water Testing pH is a measure of how acidic or basic the water is. Normally the pH should be between 5 and 7 for purified water. Any pH readings outside the expected range will indicate a possible contamination of the water. Low pH readings mean that the water is acidic and high pH readings mean that it is basic. 24  Water Testing  Total organic carbon (TOC) is a measure of the total organic content in a water sample.  Pure water has a low TOC reading as it will contain very little organic material and impure  Impure water has a high TOC reading.  If the TOC readings are outside the specified range, it means that the water has organic contaminants present. 25 Water Systems Water Purification 26  Water Treatment  Typical treatment processes include:  Particulate Filtration  Carbon Filtration  Reverse Osmosis Purified Water Generation  Water Softening  Ion Exchange Resins  Ultraviolet (UV) Light  Distillation WFI Generation  Circulation 27  Water Treatment - Filtration Filtration is an important process that removes insoluble solids from a liquid. The water coming into the plant is normally filtered to remove the initial undissolved material, before any specific treatment procedures are carried out. There are also special filters which are designed to remove micro-organisms and colloids. These have a much smaller filter size and are capable of retaining much smaller particles. Removes contaminants 10 – 20 microns in size 28  Water Treatment - Filtration Another form of filtration, activated carbon filtration, is used to remove organic material and residual disinfectant from water. Chlorine is the most commonly used water disinfectant. Residual levels of it are often present in water entering the plant. It is important to remove residual disinfectant because it can reduce the effectiveness of subsequent treatment techniques. 29  Water Treatment - Ion Exchange Resins  Ion exchange resins are specifically designed to remove ions from water.  An ion is any material that has either a positive or negative charge.  For example Ca2+ is a positively charged ion and SO42- is a negatively charged ion. 30  Water Treatment - Ion Exchange Resins  The water is passed through an ion exchange unit that contains the resin.  The resin will absorb the ions thus removing them from the water.  Resins become saturated after prolonged usage and have to be regenerated with a chemical treatment process, on a regular basis, so they continue to work effectively. 31  Water Treatment - Reverse Osmosis  Reverse osmosis is a technique used to remove ions and other dissolved contaminants from water.  The water to be purified is forced through a semipermeable membrane using pressure.  The membrane retains ions and other dissolved contaminants but allows the pure water molecules to pass through. 32  Water Treatment - Ultraviolet Light  Ultraviolet light is a form of energy that can be generated by mercury lamps.  The energy or radiation given off by the lamps passes through a water solution and destroys most of the bacteria in the water.  The UV light is absorbed by the cells of the bacteria, killing them. 33  Water Treatment - Distillation Distillation is a simple method for removing impurities from water. The in-coming water is heated. When the temperature of the water reaches the boiling point, vapor is formed.  This vapor leaves the vessel, leaving the impurities behind and is transferred to the condenser. The condenser cools the vapor back into water, which is then collected separately in a holding vessel. 34  Water Treatment - Distillation It is also important, once the water has been treated, that it is kept moving by  circulating it within a system. This reduces the risk of bacterial contamination, as stagnant water is a breeding ground for micro-organisms. Certain grades of water are stored at 80oC, which reduces the risk of microbiological contamination before use. 35 Manufacturing & Processing Technology Plant Utilities 36  Plant Utilities  Compressed Air  Steam  Gases  Water  HVAC 37  Process Utility Systems (PUS)  Manufacturing Plants need a wide range of utilities in order to manufacture their products.  Process utility systems (PUS) are required to satisfy the demands of the facility in such areas as:  Compressed Air  Steam  Vacuum  Electricity  Gases  Water  Effluent Disposal System  Heating, Ventilation and air conditioning system (HVAC)  Extraction System 38 Plant Utilities Compressed Air 39  3 Categories of Compressed Air  Process Air - oil free, dry, particle free and suitable after terminal filtration for product contact  Plant Instrument Air - Dry, particle free and suitable for pneumatic equipment  Breathing Air - as process air but HEPA filtered 40  Compressed Air  An example of the type of equipment used to create compressed air is a rotary type air-compressor. The rotary compressor is one of the most popular source of compressed air for industrial applications.  Operation: Air enters a sealed chamber where it is trapped between two rotating rotors. As the rotors intermesh, they reduce the volume of trapped air and deliver it compressed to the proper pressure level. Example of compressor rotors 41  Compressed Air  Compressed Air can be used at different pressures depending upon the application.  Plant Instrument air being used to drive valves and general equipment is generally used at approximately 6 barg.  Process air being introduced to vessels is generally used at a pressure less than 3 barg.  The pressure of the air is regulated using a pressure reducing valve. 42 Plant Utilities Steam 43  Steam  Steam is generally piped around the plant from a central boiler. The main use is for heating. It is also used in the generation of Clean Steam which in turn is used for sterilization purposes.  Steam can be produced at different pressures, at each different pressure, the steam will have a corresponding temperature value. Therefore the pressure of steam produced will be dependent on temperature requirements.  Typically the steam pressure used within the plant would be approx. 3 barg again this is controlled by a pressure reducing valve. 44  Steam  Diagram of a Typical Steam Boiler Recovered Hot Flue Fresh Condensat Plant Steam Gases water e Plant Water makeup Gas Condensate Recovery Tank Air Burne r Fire Tubes Plant Water In 45  Clean Steam  Clean Steam is used primarily for sterilisation sequences, for example loop sterilisation and sterilisation of vessels.  Clean Steam is a high purity steam produced from treated water for example De-Ionised water/ Water for Injection (WFI). It is therefore used instead of normal steam for sanitary applications to reduce the incidence of cross contamination.  Clean steam is usually utilised at a lower pressure and hence lower temperature than normal steam. As the main purpose is for sterilisation temperatures only need exceed the sterilisation temperatures i.e 121°C. 46  Clean Steam  The production of clean steam is similar to the process for creating normal steam as described previously. The difference in this case is that the normal steam is now the heating medium and purified water or WFI is the medium that is being converted to steam. Pressure Clean Steam To Plant Vessel  Example of a clean steam generator: Inlet De- Normal Ionised Steam Water Condensate Tube Bundle Out De-Ionised 47 Water In Plant Utilities Gases 48  Gases  Gases are used for a wide range of applications including  heating fuel  inert atmospheres to protect product from oxidation  purging of vessels and pipelines  operation of laboratory equipment etc. 49  Plant Utilities Electricity Vacuum Effluent Disposal System Ventilation systems 50  Electricity and Vacuum  Electricity  generally supplied from the national electricity supplier and is used for lighting and equipment power. Some plants have back up generators to cover power failures. Electricity is used throughout the plant for most pieces of equipment.  Vacuum  used for dust extraction and autoclave vacuum. It is supplied locally from a vacuum pump or from a system which is piped around the plant from a central vacuum pump. 51  Effluent Disposal & Ventilation  Effluent disposal systems  crucial on all manufacturing sites and are the focus of environmental regulations. Safe disposal of waste products and spillages  Ventilation systems  provide safe working atmospheres, prevention of contamination,maintenance of specific working conditions, provide adequate supply of air at the right quality.  Air supplied in sterile areas are absolutely crucial in ensuring product quality. Typically each building on a site will have its own ventilation system.  Extraction systems  important for both environmental control and protection of operators  remove dust or fumes from the local workplace  clean or filter the extract before discharging into the environment 52  Effluent Disposal  Example of a simple effluent disposal system 53 Plant Utilities HVAC 54  Heating, Ventilation and Air Conditioning (HVAC)  Production areas should be effectively ventilated, with air control facilities appropriate to both the products handled, to the operations undertaken and to the external environment  Temperature, humidity and Ventilation should be appropriate so as they do not adversely affect the medicinal products during their manufacture and storage 55  Summary  This section reviewed typical process utility systems 56  Learning Objectives  At the end of this section the student should now understand  The grades of water  The uses of water  The impurities present in water  The Purification Methods for water  The tests to check purity of water  The other essential Process Utility Systems necessary to support a facility