Requirement_of_external_plant_designing

Equipment Design

Equipment Design

For sanitary construction and design of food equipment, it is important to know the general aspects. Designing of processing equipment is not to just focus on the containment of the material, the strength of the components, the efficiency of the operation, and the transfer of energy. It should also comply with strict standards and regulations, which are necessary for securing the quality and safety of the food products then it can be of importance.

The surfaces of food equipment are subdivided into two categories i.e., food product contact surfaces, where direct contact of food residue or chances that it can drip, drain, diffuse or be drawn. And non-product contact surfaces are those part of equipment that do not come in direct contact with food like legs, supports etc

Food Product Contact Surfaces

In terms of sanitary design, all food contact surfaces should be smooth, impervious, free of cracks and crevices, nonporous, nonabsorbent, non-contaminating, nonreactive, corrosion resistant, durable and maintenance free. If any modification or process is used in fabrication (e.g., welded, bonded, or soldered) it should be done using appropriate materials and in a manner that ensures the final surface meets the sanitary design criteria.

  1. Materials: A variety of materials are used in the construction and fabrication for different applications in food equipment. These materials vary in their properties with regard to workability, compatibility, and sanitary design features.

Metals: Stainless steel is the preferred metal for food contact surfaces because of its corrosion resistance and durability in most food applications. Titanium has excellent durability and corrosion resistance (especially in an acidic environment), however, its use is limited by high cost. Titanium is used in stainless steel alloys for food equipment used in the processing of food products with high acid and/or salt content (e.g., citrus juice, tomato products). Copper is primarily used for equipment used in the brewing industry, with some use for cheese vats in Swiss cheese manufacture, due to tradition but should be avoided from acid processing as chances of copper leaching into product is there. Aluminum is used in certain parts and components where lighter weight is desired. However, aluminum has poor corrosion resistance and can become pitted and cracked with continued use. Carbonized metal and cast iron are only used for frying and cooking surfaces, and similar applications in food service. Galvanized iron should be avoided as a food contact surface because it is highly reactive with acids.

Non-Metals: Plastics, rubber, and rubber-like materials that should be food grade if they are coming in contact of food. Ceramics are used primarily in membrane filtration systems. Glass may be used as a food contact surface but it needs to be assured that it is durable, break resistant or heat resistant glass.

  1. Surface Texture and/or Finish: If any surface is grinded, polished, or textured in any way, it must be checked for final surface to be smooth, durable, free of cracks and crevices. The surface texture or finish of a material is decided by Ra Value (Roughness Value) which is determined using a sensitive instrument (termed a profilometer) which employs a diamond tipped stylus to measure peaks and valleys in a relatively smooth surface.
  2. Construction and Fabrication: Food equipment should be designed and fabricated in such a way that all food contact surfaces are free of sharp corners and crevices. All mating surfaces must also be continuous (e.g., substantially flush). Construction of all food handling or processing equipment should allow for easy disassembly for cleaning and inspection. Where appropriate (e.g., vessels, chambers, tanks), equipment should be self-draining and pitched to a drainable port with no potential hold up of food materials or solutions. Piping systems not designed for routine disassembly must be sloped to drain.

Internal angles should be coved or rounded with defined radii. Equipment standards specify appropriate radii for specific equipment applications and components. Permanent joints should be smooth, durable, and should meet all sanitary design criteria. Equipment standards generally require that welded joints on stainless steel surfaces be continuous, butt-type joints and ground smooth. Care should be taken when connecting pipes, gauges, thermometers, probes, or other equipment to food contact surfaces. It is necessary to ensure the connection does not create a dead end or an area where food product can accumulate and is not accessible to cleaning solutions. Shafts, bearings, agitators, and other attachments or ancillary components should be attached to food equipment in such a way that the food contact zone is sealed from contamination caused by leakage of lubricants or other contaminants into the product zone. Such components should be accessible and removable for cleaning. Any opening or cover should be designed, fabricated, and constructed in such a manner as to adequately protect food products from contamination and to divert potential contamination away from the food product zone. Openings should be lipped and covered with a shoe box type design and the top rims of equipment should be constructed and fabricated to avoid the collection of water droplets or dust.

Nonfood contact surfaces

Non-product contact surfaces of food equipment are a source for environmental contamination of a food facility with pathogens. These areas can also be harborage areas for insects and rodents. Therefore, care should be used in evaluating these surfaces of equipment with regard to sanitary construction and design. Non-product surfaces of equipment should be constructed with appropriate materials and fabricated in such a manner as to be reasonably cleanable, corrosion resistant, and maintenance free. Tubular steel equipment framework should be entirely sealed and not penetrated (e.g., bolts, studs), to avoid creating niches for microorganisms. Whenever practicable, attachments should be welded to the surface of the tubing and not attached via drilled and tapped holes.

With continuous improvement in equipment design, there is evident improvement with the sanitation, cleaning and food safety programs. Equipment designing should always incorporate the inputs and should consider the requirement of processor for coming up with design that can provide required output.

Hygienic_Designing_food_factory

Plant Building Design – Internal

Plant Building Design – Internal

Outdated and classic ways is still used by many food manufacturers to control food safety, however, the it is well known that hygienic design of food process, equipment and factories can contribute significantly to enhance food safety.

The sanitary objectives for interior building design and construction are to minimize potential harborages of pests and microorganisms, maximize cleanability and maximize the protection of the food products from contamination. Ideally, a facility should be designed to provide a flow pattern for food products (as well as personnel and equipment) to prevent potential contact of the finished product with raw materials. Flow should be in one direction and follow a logical sequence from raw material handling to finished product storage.

  1. Interior Walls: A cleanable, sanitary wall is one that is hard, flat, and smooth which is free of any type of pits, cracks, checks, and crevices. Walls should be covered with a light colored paint and caulked, sealed or grouted appropriately at joints and junctions. Junctures between walls and ceilings, and between walls and floors should be rounded (or coved) with a radius of one inch or greater. Coving minimizes a right angle crevice, which is difficult to clean and maintain.
  1. Ceilings: Improperly installed ceilings, ceilings that promote condensation, or poorly maintained ceilings (e.g., flaking paint) can increase the potential for overhead contamination of food products. The most recommended installation is the concrete slab with exposed double tee beam construction, which avoids ledges associated with I-Beam construction. Concrete ceilings should be ground smooth, appropriately finished, and caulked at the joints. Dropped ceilings are acceptable only if properly installed. False ceilings, which create a crawl space above the ceiling for utilities and services, should be avoided.
  1. Floors: Floors should be smooth, impervious, non-absorbent, corrosion resistant, cleanable and in good repair. For safety considerations, floors should not be so smooth that they cause employees to slip and fall. Floor should be installed to provide adequate slope for drainage to prevent pooled water. The most recommended are sealed concrete, epoxy sealed concrete, quarry tile, and glazed tile. Unsealed concrete floors should be avoided as they are highly porous and break down with continued exposure to chemicals.
  1. Drains: Floor drains should be of adequate number and size with appropriately located in reference to requirement. Designing and installation should focus on cleanability and scheduled maintained should be followed for good repair. Circular, catch basket drains are most often recommended provided that they are appropriately sealed and grouted to the floor, and are maintained in good repair. A trench drain should be constructed and installed to provide adequate slope or grade ensuring there is no standing water in the trench.

  1. Interior Lighting: Light fixtures should be of the type approved for food facilities, and should be equipped with break resistant lenses or shatterproof shielding. The fixtures should be designed to be moisture resistant and cleanable. Electrical boxes and related equipment should be water proof and of acceptable sanitary design
  1. HVAC Systems: Heating, ventilation, and air conditioning (HVAC) systems function to maintain the temperature and humidity of a facility. Systems should be constructed, designed, installed, cleaned, and maintained so that they are not a source of contamination. For example, the air supply should be located to not draw air from nearby sources of contamination (e.g., chemicals, bird droppings); adequate filters should be installed and duct work should be located outside of the processing areas. 
  1. Employee Facilities, Locker Rooms & restrooms: Employee facilities should not open directly into processing or other critical areas. Most food regulations require a two-door separation between locker rooms or restrooms and food processing areas or food handling areas. Lockers should be sealed to the wall and should have sloped, rather than flat, tops to prevent accumulation of dust and debris.
  2. Physical Separation: As much as is practicable, there should be a physical separation between raw and finished products and minimal entry into critical areas. Such physical separation should be accomplished by installation of walls and doorways with anti-back tracking features, and by adjusting air handling systems to provide positive pressure in finished product rooms. As the best physical separation can be undermined by human error or improper personnel flow, there should be an operational and philosophic separation between raw and finished product. This can be accomplished by barring employees working with raw materials from entering finished product rooms, this includes maintenance and janitorial staff.

A sanitary food processing and handling facility must also have designed-in (integrated) features to protect the food products from contamination. Facilities should be periodically inspected and evaluated for potential contamination of product due to the facilities themselves. Utility and water supply lines, and other accoutrements hung or attached to the wall or ceiling must be appropriately caulked and sealed to the wall or mounted in such a way to allow cleaning behind and around. Having a facility designed and built to sanitary specifications does not guarantee a safe food product if the facility is not adequately cleaned and maintained on an appropriate schedule.

External_hygienic_Building_Design

Plant Building Design – External

Plant Building Design – External

Plant design refers to the overall designing of a manufacturing enterprise/facility. The objectives of designing & constructing a sanitary food handling facility are to minimize harborages and to eliminate the entrance of pests and other sources of contamination.

Food Processing plants are quite different from the non-food processing ones, the main difference lies in areas of equipment, selection and sizing, working space design and these differences are due to storage life of foods is relatively limited and strongly affected by temperature, pH, water activity, maturity, prior history, and initial microbial contamination levels. Very high and verifiable levels of product safety and sterility have to be provided as foods are highly susceptible to microbial attack and insect and rodent infestation. Food processing generates wastes with high BOD loads which need special treatment before releasing it to environment.

Plant Designing: Premises and Surrounding

Objective for sanitary building are to minimize harborages and infestations of vermin (e.g., rodents, insects, birds, other pests), mold and mildew, and microorganisms and potential for contamination with environmental chemical pollutants.

It is imperative that an adequate pest control management program is in place for food processing and handling facilities. And proper records and documentation of a pest control program is important to the success of an overall sanitation program. Focus area’s being location of plant, site condition, preparation & maintenance, exterior lighting, driveways & receiving areas

  1. Location: Ideally, the food processing facility should be located away from sources of contamination e.g., chemical plant, sewage treatment facility, salvage yard, livestock housing, cow pasture, or body of water). In case source of contamination are found to be located near the plant, special precaution should be taken to avoid odors & contaminants from entering the yard or the facility.
  2. Site condition, preparation & maintenance: When preparing a new site for construction the site should be thoroughly cleaned of any potentially toxic materials and graded for appropriate drainage and prevention of standing or pooled water. Storm sewers should be designed and located to allow for adequate runoff and paving should be used to minimize dust. Trees and shrubbery should be no closer than 30 feet from the building, and grass coverings should end 30 inches from the building walls. To discourage rodents, gravel buffer should be established between the building and landscaping.
  3. Exterior Lighting: Exterior lighting attracts insects and hence location of these fixtures is of critical importance for preventing insects from entering the facility. The location of fixtures, especially when positioned over doorways, needs special attention. Lighting should be mounted on poles or standards, be at least 30 feet from buildings, and the light directed towards doorways and entrances. Lighting fixtures should be shielded with a non-breakable, transparent material.
  4. Driveways and receiving areas: Receiving area is the last line of defense in protecting the building, care should be taken to make sure that such areas are designed to minimize contamination and intrusion from pests. Asphalt driveways should be avoided, as this material may attract rodents. Driveways leading to receiving areas should be appropriately paved and constructed for adequate drainage. Drains should be designed with catch baskets for debris, and hose stations should be provided to facilitate cleaning and maintenance.

Plant Designing: Exterior Building

The primary objective of sanitary design in building construction should be to design and construct a building that is cleanable. Other objectives are to minimize contamination and adequately seal food processing and handling areas from sources of contamination. Simple and inexpensive preventative measures can be incorporated into building construction with regard to vermin proofing the building.

  1. Loading Docks, Platforms, and Receiving Rooms: Receiving areas and rooms should be enclosed as much as is practicable as an improperly designed and constructed receiving room will provide an attractive harborage for birds, rodents, and insects. Loading docks should be at least 3 feet above ground with the underside lined with a smooth, galvanized metal or similar material with a 12-inch over-hang to prevent rodents from climbing into the building. If overhangs should be constructed, then they should be sloped rather than flat, to be free of roosting and nesting areas for birds. Properly installed rapid open/close doors or air curtains should be used to discourage entrance of insects and birds.
  2. Exterior Walls: Building materials used for exterior walls vary in their need for preventative maintenance with regard to re-caulking of joints. For example, a poured concrete wall, needs less maintenance than other materials because it does not have seams. Low-density concrete block (e.g., cinder block), commonly used in domestic building, should be avoided unless an adequate sealer is used to avoid moisture intrusion and penetration of mold and mildew. Concrete block walls should be sealed at the base and capped at the top. Corrugated metal siding is the least desirable material for wall construction in a food handling facility. If used, it is imperative that it be adequately caulked along the base and at the seams.
  3. Roofs: The roof should be designed and built so it can be kept clean, especially where there is the possibility of product spillage or deposition on the roof. Food related dust (e.g. Flour, powdered milk, or grain) can accumulate on the roof and is an invitation to birds and insects. Smooth membrane type roofs are often the most desirable type of roof for food processing facilities. Tar and gravel roofs are usually not recommended as they tend to attract dust and are very difficult to clean and maintain.
  4. Openings into buildings: Any openings into buildings, including doors, windows, ventilation ducts, and other openings must be appropriately sealed and protected. Openings into the roof such as exhaust fans for air handling systems, ventilation ducts, and plumbing vent pipes must be sealed, and appropriately flashed and screened. Windows are discouraged in food processing operations as they present sanitation problems due to glass breakage and overall maintenance considerations. If used, windows should be designed to be flush with the inside wall and be permanently closed. Sills should be sloped away from the wall at not less than a 45-degree angle to prevent birds from nesting or dust from collecting.

Plant design specifies the equipment to be used, performance requirements for the equipment, interconnections and raw material flows in terms of flow charts and plant layouts, the placement of equipment, storage spaces, shop facilities, office spaces, delivery and shipping facilities, access ways, site plans and elevation drawings, required instrumentation and controls, and process monitoring and control interconnections, utility and waste treatment requirements, connections and facilities, the rationale for site selection, the basis for selecting and sizing critical pieces of equipment, ways in which the design was optimized and the engineering basis for such optimization.

Good_Manufacturing_Practices

Principles of GMP

10 Principle of Good Manufacturing Practises 

Good manufacturing practices is part of quality assurance which are particularly set of guidelines including basic control measure and procedures to be followed to meet standard specification of product which are safe to consume by human. These regulations address a variety of areas, including cleanliness, personnel qualifications and record-keeping, all in an attempt to ensure safety in the manufacture and care of FDA-regulated products by minimizing the chance of contamination or human error. To follow good manufacturing practices there are 10 basic principles which need to be addressed.

PRINCIPLE 1: Step by step written procedures

All operating procedures and work instructions should be written down and made available to employees for better understanding of the facility working procedures. Standard operating procedures are established methods that are to be followed routinely for the performance of the designated operations.

PRINCIPLE 2: Follow procedures

In the food industry it is critical that good procedures are in place to ensure a controlled and consistent performance. Written procedures are to be concise and logical so that it is easy to follow and understand. While following SOP or written procedure it is important to mark that no shortcuts should to be taken as they lead to deviation from the procedure which may lead to hazards.

PRINCIPLE 3 Document work

Prompt and accurate documentation of work provides official information or serves as a record helping in compliance and traceability. In case of error, these records can serve as the basis of investigation. E.g. Equipment user manual, GMP Manual

PRINCIPLE 4 Validate work

Establishing documentary evidence that the procedure, process or activity and production maintains the desired level of compliance at all stages. Maintaining and validating of consistent performance is very important. Correctly following written procedures are necessary.

PRINCIPLE 5 Integrate productivity, quality & safety into facilities & equipment

During construction of company facility and equipment it is important to integrate productivity, quality & employee safety. Designing and assigning location of equipment should suit its intended use. Segregation of materials, products and their components to minimize confusion and potential mix up and error This reinforces the goals of quality and consistency at all stages of the process. Product quality is impacted by factors like air, water, lightning and ventilation temperature.

PRINCIPLE 6 Maintain facilities & equipment

Proper maintenance of equipment and facility with valid documentation backing the details for maintenance minimizes any safety concern and avoid potential issues relating to contamination and quality control. Proper maintenance schedule prevent equipment breakdown, reduces risk of product contamination and maintain the validated state of the facility or equipment.

PRINCIPLE 7 Define, develop & demonstrate job competency

Each employee should be provided with training whose activities could affect product quality. Training should be inclusive of basic training on theory & practice of GMP as well as role related training. Employees should demonstrate job competence by producing quality products in a safe & efficient manner.

PRINCIPLE 8 Make cleanliness a daily habit

This principle outlines the importance of ensuring a product to be protected from contamination by practicing good hygiene. This can be achieved by incorporating cleanliness in the workplace on daily basis. All cleaning and sanitization procedure should be diligently followed. Apart from reporting conditions that may lead to contamination it is important to minimize human contact with product and equipment. Food contamination can either physical, chemical or microbiological in nature. Contamination can be of indirect form as well like unintentional transfer from one to another posing hazard like allergen.

PRINCIPLE 9 Build quality into the product

Every step in the products life cycle requires effective controls to ensure the quality of the product which can be achieved by controlling components, controlling the manufacturing process, packaging & labeling controls, holding and distribution controls.

Components can be kept in check by controlling ensuring all material and components are meeting the defined specifications. All components should be identified and stored in quarantine area for sampling & testing. For Controlling manufacturing process all product should have master record outlining specification with individual batch/history record. To enable traceability assigning batch no. to all products inspecting packaging & labeling before processing new batch are few of packaging and labelling control methods. And for holding and distributional control proper controls to be in place against contamination, mix ups and errors

PRINCIPLE 10 Conduct compliance & performance audits

Only way to determine how well GMP is being implemented is to conduct planned and periodic audits. Audits must be conducted to assess whether the facility is following GMP. Audits can be internally held to ensure GMP compliance by in house audits or external audits can be conducted by external bodies such as FDA etc.

Utility_Management

Utilities Management

Utilities Management

 For any food industry, the main challenge it faces during initial stage is the selection and designing of utilities. Utilities of a food industry comprises of environmental air, compressed air, water, and steam. Utilities play major role and are very influential factors for the production and for the quality of product produced.

  1. Environmental Air

Environmental air is the surrounding air that is present in the vicinity of production plant which can be highly contaminated with physical of microbiological contaminants. Manufacturing plant are segregated into manufacturing area, where the product comes into contact with the environmental conditions and non-manufacturing area, where the non-manufacturing process like packaging, warehouse, etc. takes place. Manufacturing area or production area need to be maintained at utmost hygiene as product comes in direct contact with environment. In manufacturing area certain preventive action are required to maintain the quality of the products.

    • Regular monitoring, trending and review of air quality by appropriate personnel to ensure suitable microbiological quality.
    • Maintaining suitable air pressure differentials between adjacent areas (Non- manufacturing area) in relation to positive, negative, and ambient airflow to prevent contamination.
    • Air sourced from outside to be filtered to the level required for the product.
    • Air blown on surface of microbiologically sensitive material to be sourced from within processing area.
    • Air for controlled or high controlled zones not to be sourced from unprocessed (raw) areas.
    • Air supplied to the filler in an aseptic filling system (for beverages) to be filtered through a HEPA filter (H13).
  1. Compressed Air

 Compressed air efficiently supports the food industry as long as care is taken to remove contaminants from the system. Compressed air system is of different type i.e., contact system and non-contact system, depending upon the use and it is food industry requirement that should define how compressed air is to be used in their facility and define a specification for compressed air purity based upon the system.

    • Compressed air for general applications should be dry, oil free, and filtered to remove foreign particles.
    • Compressors providing air for direct contact with food to be of oil free design. If unavoidable, food grade oil to be used.
    • When used as an ingredient, or in contact with microbiological sensitive substance, compressed air to be filtered to 0.3µ at point of use.
    • Distribution piping to be of approved material
    • Preventive maintenance of air filters to be documented

 

  1. Water

 Water in food industry have extensive consumption. Depending upon the requirement, water can be used as ingredient or component of ingredient, for cleaning and sanitation or for processing operations. Different form of water is used in industry like soft water, raw water, RO water, process water, as refrigerant or as heating medium. Quality or sanitary level depends on the intended use. Food business should follow good sense practice while considering source and treatment to ensure the quality and safety of the products. Potable water supply system should meet all local and national regulatory requirements and there is certain other requirement as listed below

    • Water microbiological quality to be controlled and meet specific requirements and performing periodic microbiological tests.
    • Test all water (reclaim water, hand wash water, water for brine solutions, recirculated cooling water, water as sanitation final rinse) to be tested for TVC (Total Viable Count) and coliform. Recommended limits are TVC< 500 cfu /ml and coliforms <1cfu/100ml
    • Initiate corrective action for out of standard results.
    • Test ozone & chlorine periodically for chlorinated water and weekly analysis of water being used in product.
  1. Steam

 In food industry, steam can be recognized into two that is plant or process steam (indirect contact or no contact with food) and culinary steam (direct contact with food or food coming in contact surface). Process steam is the steam used indirectly during processing (e.g. steam for jacketed equipment) and the steam to be produced using boiler chemicals or water treatment should be approved under local/ national regulations. Culinary steam or clean steam is suitable for direct product contact and can be directly injected into product. It can be used to sterilize the vessels or parts that comes in contact with food product. Culinary steam should be produced only using approved food grade boiler chemicals. The piping assembly for direct steam should contain an entrainment separator capable of removing particles of 30-micron size and should be delivered through stainless steel pipework to the point of use.

 

Need_for_Good_Manufacturing_Practices

Good Manufacturing Practices (GMP)

Good Manufacturing Practices

Good Manufacturing Practices (GMP) is a whole system in itself which enlist practices that is to be followed for getting consistent quality product, processed under controlled environment to meet with guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale. It enlists set of guidelines and procedures that is to be practiced by manufacturers to ascertain the minimum required quality so that the end consumer is not harmed.

Good Manufacturing Practices: Objective and Need

GMP apart from providing minimum quality, it is to achieve following aims

  1. To manufacture products of pre-determined specifications
  2. To get consistent quality end product
  3. To package product as intended and to correctly label
  4. To minimize any sort of contamination possible in the delivering product.
  5. To eliminate any chance of error during processing of product
  6. To increase the efficiency and reduce the doing business
  7. To reduce the risk of mislabelling and adulteration

Risk of product contamination are very high. Few factors contributing to the same are from people, other food materials like allergens, packaging materials, hazardous material, equipment’s, building and miscellaneous material.

Good Manufacturing Practices: Principles

  • Principle 1: –  Design and construct facilities and equipment’s properly
  • Principle 2: – Follow written procedures and instructions
  • Principle 3: – Document work
  • Principle 4: – Validate work
  • Principle 5: – Monitor facilities and equipment’s
  • Principle 6: – Write step by step operating procedures and work on instructions
  • Principle 7: – Design, develop and demonstrate job competence
  • Principle 8: – Protect against contamination
  • Principle 9: – Control components and product related processes
  • Principle 10: – Conduct planned and periodic audits

Good Manufacturing Practices: Implementation 

Key provisions of GMP to attain high quality are general provision (like personal hygiene, clothing etc.), building and facilities, defect action level production & process control and equipment’s.

  1. Personal Hygiene: Good personal hygiene helps to prevent food contamination by people. Personal hygiene involves those practices that are performed by an individual to care for one’s bodily health and wellbeing through cleanliness.

 

Personal hygiene can be maintained by taking bathing before work, cleaning and trimming nails properly, in case of cut or wound bandage the area, wear gloves, report of any employee suffering from any communicable disease, sanitizing hand before stating of work and following proper hand washing procedure, removing of uniform and personal equipment before using restroom, boots to be cleaned before entering plant and pants to be tucked in boots, unused hair bonnets and facial snoods to be worn every time.

In production floor spitting, chewing tobacco & smoking to be restricted along with taking of eating and drinking material, using of bare hand to touch faucet after washing. In uniforms pockets should not be there above waist line and same uniform should not be worn outside of plant.

             

  1. Plant and plant grounds: Grass and weeds around the vicinity of the plant should be kept eliminated as they can harborage for unwanted pests. Plant should be free from trash and refuse. Roads and parking lots associated with facility should be paved and there should be adequate ground drainage facility.
  1. Plant construction and design: Plant construction and design for new construction, expansion and reconstruction work should be designed and executed for
  2. Easy cleaning and sanitization of plant and sufficient room space for same
  3. Internal roofs and top angle’s in processing area to be designed that minimize the dirt buildup and condensation and should be easily cleanable.
  4. Floors to be properly sloped to avoid water accumulation and proper drainage in areas where water usage is more and all drains should have cover and pest traps.
  5. Material for wall construction should be of anti-corrosive materials. Selection of paint should be on basis of non-toxic, odorless, smooth, water prof, easy to clean and light colored.
  6. Smooth and anti-absorbent materials should be used for floors, doors and windows for easy cleaning and disinfection purposes.
  7. Lighting and ventilation to be adequately designed with safety fixtures.
  1. Equipment: Equipment’s can be source of contamination to the product either by coming into direct contact or can be indirectly spreading contamination. For prevention from both cases it is important to have preferable design of equipment which provides better cleanable contact surface. Other parameters that should be considered are: 
    1. Food contact surfaces to be inert, smooth & non porous (SS preferred).
    2. Equipment installation to have 3 feet around clearance & to be 6 inches off the floor.
    3. Production equipment’s to be arranged as per technical procedure to avoid cross contamination.
    4. Equipment assembly parts like bolts, nuts, gaskets etc. not to be kept near equipment during operation.
    5. Mobile equipment cleaning and storage not to be done in processing area.
    6. Nonfood grade lubricants for equipment’s not to be used.
    7. To follow maintenance and service schedule for equipment.
  1. Production and Process Control: For production & process control one should follow sanitary principles during operations like receiving, production, transportation, processing and storage. Inspection can solve lot of problems in this section. 
    1. Raw materials to be inspected and separated from processed products, raw material containers need to be inspected
    2. Regular inspection & cleaning of food processing equipment.
    3. Documentation of various processing factors such as time, temperature, humidity, pressure & other relevant variables to be properly controlled & documented.
    4. To ensure traceability finished goods should be coded.
    5. Production records should be properly maintained.
    6. Testing procedures to be in place for checking finished product quality & safety.
    7. Packaging materials to be approved & provide appropriate protection

Making poor quality product doesn’t save money in long run as they can cause recalls and affecting the brand name. GMP always is a good investment in good quality product and is best way to conduct business as it is designed to ensure that mistakes do not occur. One important flexibility GMP guidelines provide are that manufacturer can determine the effective method for efficiently setting up quality program at their end that shall be meeting business and regulatory control.

Lyophilised_Treated_Product

Lyophilisation

Freezing is a unit operation in which temperature of a food is reduced below its freezing point (removal of sensible & latent heat of fusion), and a proportion of the water undergoes a change in state to form ice-crystals. Immobilization of water to ice and the resulting concentration of dissolved solutes in unfrozen water lowers the water activity of the food. Lowering of temperature, lowers the microbial activity as well as suppresses the chemical reactions in the food. Generally, we find two type of freezing method, quick freezing and slow freezing. In slow freezing, food products are introduced to low temperature for relatively longer time duration and hence the ice crystal formed are of larger in size, which are sometimes not at all desirable depending on characteristic of food product. In quick freezing, relatively even lower temperature is used for food product but exposure time is less. Hence the ice crystal formed are of smaller size. Even though small ice crystal formed during quick freezing helps in preserving the texture and other characteristic of product, sometimes it may cause to temperature shock to product. Choosing the method of freezing is hence of utmost importance.

Also known as freeze drying, lyophilisation is a preservation technique extensively used in food industry for preserving food material and for prolonging shelf life. Freeze drying technique is a non-thermal preservation technique used for majorly heat sensitive food product. Freeze drying employs treatment of food product in controlled temperature to preserve the main characteristic of product that can be lost in case exposed to uncontrolled condition. Freeze drying can be highly effective for preservation of wide range of product including fruits, vegetables, meats, flavours, herbs, coffee etc. Temperature used in lyophilisation is between -50 to -80 deg. C and product can be kept as such, without any characteristic changes for several years in case of unopened condition and can last for at least few days after opening if stored in refrigerated condition.

Lyophilisation Technique

In lyophilisation, temperature of product is brought down to such a low temperature where the solid, liquid and vapour coexists, which is also known as triple point. In this process the initial liquid solution or suspension is frozen, the pressure above the frozen state is reduced and the water removed by sublimation. Thus a liquid-to-vapor transition takes place. If, however, solid ice is maintained at a pressure below the triple point then on heating the ice will sublime and pass directly to water vapor without passing through the liquid phase.

Lyophilisation involves three steps, involving freezing, primary drying and secondary drying.

  1. Freezing: Free water present in product is freezed to change its state from liquid to solid. Product is freezed below its triple point. Reason for bring down temperature to triple point is that it helps in the next step of the process. Freezing is the most important step of lyophilisation and it is preferred to have larger crystals to easily sublime it.
  2. Primary Drying: Second step involves lowering of pressure and providing enough heat to sublime the ice to vapour form. It gets easy due to the product existing in its triple point temperature. In this primary drying phase, about 95% of the water in the material is sublimated. In industrial level, this is most time taking process as slightly higher temperature can lead to deterioration of texture of product. Controlled pressure act as catalyst for sublimation.
  3. Secondary Drying: Then comes secondary drying, which primarily focus on the removing of unfrozen water. The temperature is raised higher than in the primary drying phase, and the pressure is also lowered in this stage to encourage desorption. Before sealing the product in packages, it is treated with inert gas to break the formed vacuum. For food product, nitrogen gas is used.

Industrial Requirement:

A lyophilisation plant consists of:

  1. Drying chamber having temperature controlling plates
  1. Capacitor to collect the water coming out of the product in the drying chamber
  2. Cooling system
  3. Vacuum system to reduce the pressure in the room
  4. Capacitor for the drying process.

The food product is firstly freezed to its freezing point, even liquid product is freezed below their freezing point. Then they are placed in the drying chamber where temperature of the chamber is set according to the product to be freezed and is always below 0 Deg. C. Applied vacuum facilitates ice evaporation which again lower the temperature of the product which are compensated by heating the product a bit by means of heating plate. The vapour evaporated is again freezed and during the process, freed water is drained.

Pros and cons with Freeze drying

Due to low temperatures, the chemical decomposition, particularly hydrolysis is minimized. There is no concentration of solution prior to drying. Hence, salts do not concentrate and denature proteins, as occurs with other drying methods. Again the basic importance or need for lyophilisation is due to decrease in weight and bulk of the product which helps in handling of bulk material during storage or transportation. Shelf life of product increases by reducing the microbial attack and self-metabolic activity.

Even Lyophilisation have their own limitation as it yields a very hygroscopic product and makes it difficult to maintain the required storage condition at every step. It is also very time taking process and the processing plant very complicated making it very expensive and can be used of higher quality product. Though it beneficial for heat sensitive product but again it can be used for certain types of products only. Chance of deterioration of fatty tissue by rancidity is the major drawback to the sensory values.

People having less time due to busy schedules are looking for alternatives to time taking cooking. For this purpose, product with longer shelf life are required which need to be coupled with less price. In larger food industries freeze drying are helping with convenient bulk handling of products and long shelf life which are the basic and most important requirement. Freeze drying segment is thriving on the basis of introduction of new technology, product type and innovation in packaging for holding freeze dried product. Increasing demand of canned and frozen products supports the growth of frozen food industry.

Clean_Room_Flooring

Cleanroom: Making Way for Hygienic Food

Cleanroom: Making Way for Hygienic Food

Rooms free from any type of dust or contamination are essential for providing a secure environment for food handling and processing. Level of contamination in clean room are very specific to number of particle per cubic meter of specified Particle size. Controlled environment is achieved by permitting least amount of pollutants in the room by supplying control filtered air. Pollutants may vary from dust, airborne microbes, aerosol particles, and chemical vapours which differ highly in size making the environment highly complex.

Need for Cleanroom

Present day requirement for healthy foods had led to revolutionary change in food industries, bounding food Companies to manufacture products in utmost hygienic environment. Increase in customer awareness, have compelled food companies to process foods to hygienic standards to withstand the wide competition. Stringent laws and regulation set up by food authorities have also helped to achieve this goal. Even small amount of contamination can have detrimental effect on the quality of product which can lead to product rejection, loss in brand name and also legal issues. Cleanrooms are the most effective solution to overcome the above said issues.

FDA has certain norms starting with strict environmental control, determining classification, detailed planning & designing for clean room. It is always advisable to have written procedure for contamination prevention which can help in maintaining the cleanliness of room. Typically, organisation should be aware of their cleanroom requirement and the requirement should be set on the basis of customer, industry or government specifications.

Cleanrooms should be accessed only with specific dress suit. Dressing also varies with various class of cleanroom. Class 10,000 cleanrooms may use simple socks, head covers, and booties. For Class 10 cleanrooms, careful gown wearing procedures with a zipped cover all, boots, gloves and complete respirator enclosure are required. Hence it can be concluded that complexity of dress code depends on class of cleanliness.

Cleanroom Classifications

Cleanrooms are classified on basis of purity of the air i.e., by the number and size of particles found in per volume of air. ISO 14644-1 states the specific standards for cleanroom operation. Standardly the cleanroom includes classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, with ISO 1 being the “cleanest” and ISO 9 the “dirtiest” class (but still cleaner than a regular room) and the most common classes being ISO 7 and ISO 8. In food industry most commonly used class is Class 10,000 which limits particles to 10,000. ISO 14644 standards require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area. Widely accepted measurement being the number of particles equal to and greater than 0.5mm measured in one cubic foot of air.

Cleanroom Designing parameters

Cleanroom designing are very specific in respect to the product coming in contact with the room. Specific requirement of product like temperature, pressure & RH requirements. Temperature should be maintained within 22±2 deg. C and RH to be maintained within 50±5 % range. Most important factor is that all incoming air has to pass air filtration system before entering cleanroom. Air entering room passes through HEPA filters which has capacity of trapping and filtering particles of size that of 0.3 micron and larger.

1. Cleanroom Air Handlers:

Keeping pressure static in cleanroom is essential for avoiding the chances of infiltration into the room which can be achieved by maintaining balance between supply air and exhaust air. Air Pressurization maintains the overall clean environment in room. Maintaining a positive air space pressure, in relation to adjoining dirtier cleanliness classification spaces, is essential in preventing movement of contaminated air into cleanroom. Through many studies it has been concluded that a pressure differential of 74.65 to 124.42 Pa to be effective in reducing contaminant infiltration. It is also to be noted that maintaining such higher space pressure difference will be costly affair and will hinder with doors opening and closing. Hence it is recommended to keep the maximum pressure differential across a door to be 24.88 Pa.

To comply with GMP requirement cleanrooms should be supported by HVAC system.

  • Fan filter unit should comprise of either HEPA filter or ULPA (Ultra Low Particulate) filter, depending on requirement of process.
  • Particle trapping capacity should be 0.3 micron or above to trap bacterial particles as well.
  • It is highly recommended to have variable speed controllers for controlled of air flow in cleanroom.
  • Either the body should be of stainless steel or should be powder coated. Grills in room should be of Stainless Steel.
  • Proper and scheduled cleaning helps in maintaining the quality of cleanroom and will increase the shelf life of filters as well.
  • All duct works in cleanroom require to be fabricated so prevent gaps at corners or joints.
  • Ducting should have flanges and gaskets can be used to prevent any sort of leakage of air to prevent cross contamination.

2. Cleanroom Walls: Cleanroom Surfaces are kept reflective, enamel like texture, making it easy for cleaning. Walls, ceilings and flooring are painted with light shade color or kept bright white to easily detect presence of dust.

3. Cleanroom Doors: If openings are not handled properly they possess threat to the cleanroom environment.

  • Cleanroom doors should be void free and should have non Porous Construction and designed to meet GMP requirements.
  • Doors should be durable and unaffected to different cleaning process like steam, water or chemicals.
  • A pass through chamber, which are enclosed space, can be considered in place of doors for material transfer between cleanroom and other area which restricts man movement in the cleanroom.

4. Cleanroom Lighting: Sole criteria for designing cleanroom lighting should be for controlling of contamination. Most basic design for cleanroom that can be considered are    teardrop, recessed, surface mount and integral ceiling grid and selection should be on the basis of cleanroom classification. As most of the space is basically used up by the supply air grids which basically leaves back only limited space for lighting. Hence to use up available space efficiently require proper designing and it should also not disturb the air flow movement in the room.

  • It is recommended to use powder-coated steel, anodized aluminium or stainless steel fixtures in ISO Class 5 (Class 100) to ISO Class 3 (Class 1) cleanrooms.
  • Electrical Outlet covers should be used inside the cleanroom to reduce the dirt build up.
  • It should be flushed mounted in SS Wall Plates and wire should be conduited inside of walls.
  • Lines for data & telephone should also be conduited and designed in a manner they are installed inside of the wall with pull string for field connection

5. Cleanroom Flooring: All particles entering room ends up on the floor making it prime site for contaminants.

  • It is advisable to quickly fill or repair flooring of cleanrooms in case of cracks or gaps that can be area for dust accumulation.
  • Apart from selecting floor which are easy to clean, it should also be durable enough to withstand pressure or else it will lead to cracks.
  • Flooring solution for cleanroom ranges from tile to heat welded sheet flooring which totally depends on the operational need of particular cleanroom.
  • For food industries it is best to go with epoxy flooring for normal food processing area or polyurethane flooring for highly hygienic area due to its antibacterial properties.

Cleanrooms are only efficient when properly designed with keeping all required parameters in mind or else they can be unreliable, leading to failure of cleanroom. It is always recommended to get your cleanroom designed and have construction under the supervision of experienced person. Cleanrooms presents numerous challenges to designing. Critical nature of cleanroom processes requires thorough analysis, specification and placement of the all parameter under one umbrella.

Food_processing_Industry_in_India

Food Processing Industry of India – An Insight

Food Processing Industry of India– Insight into Nourishment Industry

Food processing term refers to transformation of raw agricultural produce, by means of processing, into products that can be used as food. Food processing sector can be considered as ligature between agriculture and industry.

After China, India ranks 2nd in agricultural output provider which is facilitated by wide climatic variation with 20 agro-climatic regions. India enjoys all 15 major climates that exist worldwide. Processing of agricultural produce provides lucrative prices for produce benefiting Indian economy. Government realises the high domestic demand and consumption as well as huge foreign market for processed foods.

India offers the largest diversified production base, giving upper hand to channelize its raw material in Food & Beverage Industry.

  • Largest producer of milk– India is the largest producer of milk and second largest producer of fruits, vegetables, cereal pulses.
  • Largest livestock population– India has the largest livestock population of around 512 million, globally comprising of 119 million milch animals, 80.06 million goats and 44.56 million sheep, contributing about 25 per cent to the country’s farm GDP
  • Consumer awareness and preference– Due to awareness and health consciousness people are seeking for organic foods and are willing to pay for nutritional foods.
  • Open export market– International market has shown great demand in Indian processed food. Reason for this hike in demand is also due to many Indians living in foreign countries.

The Associated Chambers of Commerce and Industry of India (ASSOCHAM) stated in one of its report in 2017 that food processing industry is expected to reach US$482 billion by 2020. However, in 2019 itself the revenue in food & beverage segments amounts to US$570m. Some of the big names in this sector are PepsiCo, Glaxo-SmithKline (GSK), Mapro Foods, Dabur, Parle, Nestlé, Frito-Lay, and Haldiram, etc.

Why Lacking Behind!

Despite of having such significant backbone of agricultural production, we are able to process less than 10 % of the total produce, making significant loss in the economy, which is quite less when compared to other developing countries which are able to process around 30-50 % of their overall produce.

  1. Weak supply chain– Due to high variety in products and some are highly perishable product. They pass through long food chain which increases the percentage of loss.
  2. Inadequate infrastructure– No Proper Facilities such as packaging facilities, storage, transportation, cold chain for proper storage and transportation of raw material.
  3. No stringent rule on following standards– Low quality processing standard are followed and lenient punishments even if caught make it even worse.
  4. Post-Harvest Losses– Ministry of Food Processing Industry (MoFPI), shared report stating annual loss of US $1.5 billion (Rs 92,000 crores) in respect to post harvest losses showing where we are lacking the most.

Sector & it’s Revenue 

  1. Fruits and vegetables – India is the world’s 2nd largest producer of fruits and vegetables. 25 per cent growth in the sector is expected in total production by 2025.
  2. Milk– India is the largest producer of milk in the world, with the production estimation of 146.3 million tonnes in 2015.
  3. Meat and poultry – India is the largest producer of buffalo meat (1.4 MT in 2015) and the second largest producer of goat meat (0.91 MT in 2015). India is also the second largest egg producer (78.4 billion) and third largest producer of broiler meat (4.2 million tonnes in 2016), globally.
  4. Marine products– Total fish production in India was estimated to be 13.0 MT during 2015-16. Andhra Pradesh was the largest producer of fish with production of 741.3 thousand tonnes during 2015-2016 (up to June 2015).
  5. Grain processing– India is a producer of more than 200 million tonnes of different food grains every year. Total food grains production reached 270.10 MT in FY-16 (As per Ministry of Agriculture).
  6. Consumer food– Among the fastest growing segments in India, it includes – packaged food, aerated soft drinks, packaged drinking water, alcoholic beverages

Future Opportunities

Agriculture will keep on playing a vital role in the Indian economy and food processing will go a long way for providing opportunities for sustainable and profitable agriculture in time to come. The rise in food processing sector can be marked if post-harvest losses can be curbed for which government has sanctioned and launched various schemes like Mega Food Parks, integrated cold chain etc. in food processing sector is great opportunity for private players. There is special need to follow food safety and quality assurance mechanism for achieving several benefits. Stringent quality & Hygienic norms will enable the food processing market to keep up with global competition.

Situational Leadership

1. The slow and steady wins the race.

Yes, we all know and understand this quote like it’s common sense. But wait, actions create value, not words, not knowledge. Did we ever take a moment off to introspect whether we are really enacting this principle? Do we consciously allocate tasks, in our multi-tasking life, in “slow and steady” deserving category and rest? Or are we just steadily slow in all the work we do, and paradoxically regard our inefficiency as a core competency. Of course, we don’t have the time to think and answer these “unproductive questions”, and “results” are what matter in the end. We don’t want to be the slow turtles, we want to be fiery tigers, don’t we?

Results matter, but when logic and systematic thinking is betrayed, chaos is the dead end. Like a Ponzi scheme, the ride up is extremely cheerful. Unless we understand WHY we are doing it, knowing WHAT and HOW we are doing it, is like boating with the stream with no oars. Once the stream turns turbulent, we are helpless. Devoid of options and logic, we blame the waters, we rue the spent years it took to build the boat, and we pray that we don’t end up in a waterfall. And therefore, being Slow and Steady means being in command, with long term objective in sight, aligned short term objectives, and actions to back all of it. Being slow and steady means knowing 20% tasks which matter the most, and concentrating 80% of our energy and efforts on those.

Sometimes we wonder this quote is to idealistic, probably applicable up to the Utopian world of high school and college, and much too distant in the real world chaos. Early space travel had a probability of one failure every nine attempts. Before the successful Apollo 11, out of a total of 71 recognized attempts made, 70% failed in their missions. Had the scientist not followed a logical & systematic approach, out of the 41 missions after Apollo 11, 31 would not have been successful.

Facebook, Twitter, Youtube, WhatsApp, and similar are called disruptive technologies; they disrupted the existing game and the playing field. Therefore, to achieve success we must first identify our game and our playing field, and then selectively take up only those activities which positively disrupt our chances of success, rest all are distractions.

2. Fast and consistent will always beat the slow and steady.

It is good to be slow and steady, but it is better to be fast and consistent. Being fast and consistent allows for immensely greater value creation from the same set of resources, compared to being slow and steady. It demands greater focus, unrelenting attitude, and efficient diligence while managing and minimizing the risks. A well executed fast and consistent approach leads to definite differential gains, unlike say stock markets, where again we are boating with no oars.

Fortunately, the 21st century is intrinsically fast. Technology has made every task faster, except may be sleeping – one still needs a good sustainable eight hour sleep. 90% of tasks are automatically and repetitively done by machines, we only need plan, organize resources, and ensure the whole system is up and running. However, a consequence of majority of tasks getting automated is that, we end up with a very minor scope for making mistakes. And therefore, unfortunately, the learning curve to becoming consistent has turned quite steep, and the path of consistency has very low margin for error.

A gradual and sustainable path to becoming consistent is, putting our 100% efforts in the job or not doing the job at all. When we give our best, we end up understanding our weaknesses and improvement areas. When we give our best, we never regret our actions, whether we end up with success or failure. Absence of regret & negativity alchemises into positive and confident attitude, with sharper, insightful and pro-active instincts. And finally we end up with the secret elements of becoming consistent; by being insightful and pro-active in our thoughts and actions.

3. First identify your core competency and then change the playing field to suit your core competency.

In the early days of Google Docs, Microsoft was (and still is) the world leader in Document Editing Software (DES) business. Microsoft had the most advanced suite of software (Word, Excel, Powerpoint, Project, Note, etc.) built over expertise and experience of more than 15 years. Clearly capturing the market segment and creating a revenue stream by developing a new DES, superior and better than Microsoft Suite, was an unrealistic task. DES was undoubtedly Microsoft’s core competency and not Google’s.

So Google identified their own core competency, i.e. Gmail User Base. They developed a simple document editing interface, integrated it with their existing email-portal, and offered it free of cost to its entire user base, wherein Microsoft was charging $100 per user per year. They literally changed the game: revenue from advertising, not from software, and the playing field: their own huge user base, not Microsoft’s. Today, Google has Google Docs user base of 120 million, and substantial market share of cloud services as well.

What we can learn from this anecdote is, despite the individual brilliance we may possess, instead of trying to do everything, identifying one’s core competency and building upon it is the sure-shot ladder to success, as no one else can match it or do it better. Being jack of all trades is great in early part of one’s career, but to climb higher places we must become master of some.

4. It’s good to be individually brilliant and to have strong core competencies, but unless you are able to work in a team and harness each other’s core competencies, you will always perform below par because there will always be situations at which you will do poorly and someone else does well.

Being good or better at something/ multiple things spins off, more often than not, into an illogical conclusion that we can do everything, as good as others if not better. This becomes extremely counter-productive in a team environment when we stop acknowledging the competencies of individuals. On one hand, the disillusioned super-competitive individual gets loaded with far more work than he can manage, eventually damaging his performance in his core-competency field as well. On the other hand, the apparently competency-less individual labors on, without motivation or desire to perform, and ends up with inferior results.

The very contrasting nature of 20th and 21st century compared to earlier times has been, One-Man-Shows/ One-Man-Army concepts don’t work now; scope and complexity of work has gone beyond capacity of a single individual. Even artists need outsourced expertise of sales, marketing, IT support, etc. to make a living. Nevertheless, to turn a blind eye to a blatant fact is another unique human capacity. The hierarchical nature of organizations, categorizing people into managers, executives, officers, etc. worsens the whole problem even further. However, we are now also seeing various start-ups and large companies working with a flat structure and avoiding the kingly-times hierarchical setup, wherein justifiably discipline was foremost requirement.

Situational leadership is the leadership style that produces results most effectively and efficiently in today’s world. It encompasses knowing the strengths, weakness, and potential of the team members, and timely empowering the most suitable person to take lead, basis need of the hour. Even though the internet age and education industry has made information and human resources abundant and cheap, managing stakeholders, scope/ time/ cost/ quality constraints, and extracting the right results via a finite set of people is more challenging than ever. Adopting Situational Leadership is the need of the hour.