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PREMISES , PLANT LOCATION & LAYOUT:

PREMISES , PLANT LOCATION & LAYOUT PREPARED BY: GAYATRI RANA M.PHARM,QA(Roll No.17) GUIDED BY: Dr. NEHAL J. SHAH PRINCIPAL,DHARMAJ DEGREE PHARMACY COLLEGE,DHARMAJ. 1

TOPICS::

TOPICS: Premises Plant location & layout Building : Design & construction Sanitation & maintenance Utilities Environmental control Control of contamination 2

Location & surroundings:

Location & surroundings Selection of site for pharmaceutical industry is an important decision. Ideally, location of factory site should be hygienic & surrounding such as to have minimum sources of pollution. It should be away from open sewage, drains, public lavatory, any factories that produces disagreeable or obnoxious odour or fumes or larger quantity of soot, dust, or smoke. 3

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Other factors that should be considered while selecting a site for pharmaceutical factory include : Transportation facilities for transportation of men, equipments & materials. 2) Availability of suitable water. 3) Availability of electricity power. 4

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4) Availability of maintenance facility for repair & maintenance of plant. 5) Availability of communication facilities. 6) Proximity of civic facilities like education, housing, recreation, local transport, shopping etc. for factory personnel. 5

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7) Govt. incentives like cash subsidies, tax exemptions etc. It is very difficult to find a site which will have all the requisite plus points. Therefore a balance has to be struck between plus & minus points. Existing units should take all possible measures to prevent contamination from surrounding. 6

Building : Design & Construction:

Building : Design & Construction The first step in construction of building is to make layout . There are many points which should be kept in mind while designing a layout for factory premises: Total area of land. Percentage of area that can be covered under local laws.

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Dosage form to be manufactured(Tablets , capsules,injections , ointments etc .). 4) Scale of operation. 5) Type of equipments, plant & machinery to be used i.e . manual, semi automatic or automatic. 8

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Different areas that are required to be provided in a pharmaceutical factory (i.e. storage areas, weighing areas, production areas, quality control areas, ancillary areas ,etc.). Requirements of separate buildings for hazardous materials or process or complete isolation of some buildings. Specific requirements of dosage form (e.g segregated area for granulation, compression & coating processes in mfg. of tablets). 9

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9) Specific requirements of utilities ( e.g boiler for generation of steam , gases ). 10) Provisions of national / local laws( In India, the factory buildings should comply with the provisions of the Factories act & rules made thereunder ). 11) Future projects. 10

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The layout & design must aim at minimum risk of error, permitting cleaning & maintenance in order to avoid contamination, build up dust or dirt & any adverse effect on quality of product. Services of a practising architect may be availed in preparing layout of factory building & may be got approved from Building Construction Regulatory Authority like Municipal Corporation. 11

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Construction of building should be such that it ensures protection of product from contamination , provide effective cleaning , avoid accumulation of dust & dirt & prevents entry of birds, rodents, insects etc. 12

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Guidelines for preparing layout, designing & construction of building 13

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Toilets should not come in contact directly either with production area or with storage area. There should be adequate facilities for changing & storing clothes & for washing & toilet purpose & should be easily accessible. Rest & refreshment rooms should be separated from other areas. If possible, there should be a separate building for animal house but if it is not possible for economic reasons, it should be well isolated from other areas & should have separate entrance & air handling facilities. 14

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5) Maintenance of workshop should be separated from production area. 6) Floors should be smooth & impervious . This can be achieved in cement flooring or mosaic flooring. 15

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Internal walls should be plastered with cement to smooth finish & should be finished with appropriate paint. Acid & alkali paint should be applied to the surfaces likely to be affected by alkaline & acidious fumes. Ceramic glazed tiles up to height of 2meters from floor level may be provided on internal walls of laboratories. Ceiling should be smooth & impervious . This can be achieved by plastering with cement to smooth finish & by painting. 16

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Pipes, ducts or other structural materials passing through walls must be sealed at the point of entry. 10) Expansion joints in floors should be filled with resilient materials. 11) There should be minimum projecting ledges, shelves, cupboards, fixtures & fittings in manufacturing area so as to avoid dust & facilitate cleaning. 17

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12) Doors & windows should be hard, smooth & impervious.This can be achieved by flush type of door made up of metal sheet or wooden block board & finished with paint or polish. Door shutter should be made of steel or wood & should be tight closing type. Wherever required, hydraulic door closers should be provided to shut the doors immediately. Sliding doors should not be used because it can not be cleaned easily & are not tightly closed type. Now a days, a synthetic materials Nuwud MDF is available. 18

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This materials are fire resistant, moisture resistant, termite & fungus resistant. This is also crack, chip & split resistant.Tailor made doors of synthetic materials are also available. Window frames may be made up of steel, aluminum, wood or PVC & all window frames & shutter should be paint to fine finish. Glass fixed windows should be smooth & free from uneven surfaces. 19

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13) Drains in the building should be of adequate size & should have trapped gullies.Where drains are directly connected to a sewage, these must be provided with air break or other mechanical device to prevent back siphonage. Passage of width (usually 4-5 ft ) should be provided to facilitate movement of personnel, machinery & materials. As far as possible,open channels should be avoided. If these can not be avoided, these should be shallow, to facilitate cleaning & disinfection. 20

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16) Air intake & exhausts associated with these should be installed in such a way that do not pose any problem of product contamination. 17) Area where inflammable materials are to be processed , should be constructed with flame proof materials . Walls of this area may be plastered with cement to fine finish & painted with fire resistant paint . Doors & windows may be made of metal. Spark proof electrical fitting should be used in this area. 21

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18) Some pharmaceutical products have medicinal hazards .e.g live micro organisms, some sensitizing materials like penicillins . Therefore there should be a separate area for processing of such materials. Area of packaging of pharmaceutical products should be so designed as to prevent mix up & cross contamination. Q.C area should be segregated from production area, specialized testing facilities like biological, microbiological isotopes testing methods should be segregated from each other.These facilities should be provided with separate air handling system & other provisions. 22

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21) A separate room should be provided to sensitive instruments to protect them against electrical fluctuation, vibrations, excessive moisture & other external factors. 22) If a boiler is installed, it should be outside the main working area & should meet the national statutory requirements. 23

Plant Layout::

Plant Layout: Definition: Plant layout refers to the arrangement of physical facilities such as machinery, equipment, furniture , materials, etc. within the factory building in such a manner so as to have quickest flow of material at the lowest cost & with the least amount of handling in processing the product from the receipt of material to the shipment of the finished product. 24

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Importance: ‘’ An ideal plant layout should provide the optimum relationship among output, floor area & manufacturing process.’’ It allows flexibility of operations, easy production flow, makes economic use of the building, promotes effective utilization of manpower & provides for employee’s convenience, safety, comfort at work, maximum exposure to natural light & ventilation. 25

Types of Layout: :

Types of Layout: An entrepreneur must possess an expertise to lay down a proper layout for new or existing plants. As far as small business is concerned, it requires less areas or space & can be located in any kind of building as long as the space is available & it is convenient. There are 3 types: 1) Manufacturing units. 2) Traders. 3) Service Establishments. 26

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1) Manufacturing units There are four types: a) Product or line layout b) Process or functional layout c) Fixed position or location layout d) Combined or group layout a) Product or line layout: Under this, machines and equipments are arranged in one line depending upon the sequence of operations required for the product. b) Process layout: In this type of layout, machines of similar types are arranged together at one place. c) Fixed position or location layout: The major product being produced is fixed at one location. Equipment labour and components are moved to that location. All facilities are brought and arranged around one work center . 27

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d) Combined or group layout Certain manufacturing units may required all three processes namely : intermittent process continuous process representative process 28

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Specific areas Ancillary areas Storage areas Weighing areas Production areas Quality control areas Ancillary Areas Rest and refreshment rooms should be separate from manufacturing and quality control areas. Changing, washing and toilet areas should be easily accessible and in appropriate numbers. Animal houses should be well isolated & there should be separate air handling units and entrance. 32

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Storage areas - 1 Storage areas should be of sufficient capacity. Orderly storage of different categories of materials and products. Separate areas for starting materials, packaging materials, intermediates, bulk drug, finished products, quarantined, released, rejected, returned and recalled products and materials. 36

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Storage areas - 2 Appropriate temperature and relative humidity conditions within defined limits provided , controlled, monitored and recorded. Storage areas - 3 Quarantine area: clearly marked and access restricted to authorised personnel. Sampling area should be separated from storage area so that no risk of contamination or cross-contamination. 39

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Segregated areas for rejected, recalled and returned materials and products. Safe and secure areas for highly active, radioactive materials, narcotics and other materials (risk of abuse, fire, explosion). 40

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Storage areas – 4 Printed packaging materials Critical to ensure compliance with correct labelling of products. Special attention to safe and secure storage. Ensure compliance with specifications & prevent mixups . Weighing areas Weighing operations should be performed in separate areas. Appropriate design (HVAC ). Provision for dust control. Smooth, impervious, durable, easy-to-clean finishes. Cleaning procedures and records. Documentation, e.g. SOPs, log books and records 42

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Production areas - 1 To minimize the risk of cross-contamination: Dedicated and self-contained facilities for some products such as highly sensitizing materials (e.g. penicillins ) or biological preparations (e.g. live microorganisms ). Separate facilities for other products such as some antibiotics , hormones, cytotoxic substances ,etc. Non-pharmaceuticals normally not in the same facility, e.g. pesticides, herbicides. 43

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Production areas -2 Layout in accordance with sequence of production. Appropriate cleanliness level. Adequate work space and in-process storage space. Orderly and logical positioning of the equipments to minimize the risk of contamination, mix-ups and missing production steps. Specially designed areas for packaging. Layout to avoid mix-ups and cross-contamination. 44

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Production areas - 3 Starting and packaging materials, intermediates and bulk exposed to environment: Interior surfaces (walls, floors, ceilings) –smooth, free from cracks and open joints. No shedding of particles. Easy and effective cleaning. Disinfection if needed. 45

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Production areas - 4 Design of pipe work, light fittings, and ventilation points. Drains of adequate size and equipped to prevent backflow. Open channels avoided. 46

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Production areas - 5 Effective ventilation with air control facilities including filtration of air to a sufficient level to prevent contamination and cross contamination. Control of temperature and relative humidity wherever necessary. Regular monitoring of conditions during production and non-production periods. 48

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Sanitation & maintenance:

Sanitation & maintenance Premises used for the manufacturing of finished products should be suitably designed and constructed to facilitate good sanitation . Building used in the manufacturing of intermediates & APIs should be properly maintained, repaired & kept in a clean condition. Written procedures for cleaning of facilities & equipments must be established assigning responsibility for sanitation & describing the cleaning schedule, methods, equipments & materials to be used in cleaning building & facilities. 51

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When necessary , written procedures should be established for the use of suitable rodenticides, insecticides, fungicides, fumigating agents, cleaning agents & sensitizing agents to prevent the contamination of equipment, raw materials, packaging/labeling of materials, intermediates & APIs. 52

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The manufacturing premises should be cleaned & maintained in an orderly manner , so that it is free from accumulated waste, dust, debris & other similar materials. A validated cleaning procedures should be maintained. A routine program shall be drawn up & observed, which shall be properly recorded. 53

Utilities & services:

Utilities & services Utilities that will affect the product quality i.e steam, gases & compressed air should be qualified. Commonly used utilities are : 1) Water (portable, purified or distilled) 2) Steam 3) Gases( e.g Nitrogen, air, CO 2 ) 4) Lighting 5) Air System 54

Water:

Water Supply of water is met either through water supply by local body or through tube well. Quality of water should be monitored to control the quality of product. Suitable water treatment plants may be required for different requirements of water e.g water for boiler , water for cooling tower, water for production of active ingredients, water for sterile products,etc. Water system should be validated & maintained with appropriate action limits. 55

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For sterile products, water should be monitored for : 1) TMC ( Total microbial content) to be estimated to access safety. 2) Objectionable microorganisms & endotoxins must be absent. The water for non-parental is the demineralized water , passed on 0.2 µ filter and UV lamps , circulating all the times to prevent dead points and decrease microbial proliferation. The water used for sterile products is sterile distilled water circulating all the time and preserved at 80ᵒC to prevent microbial growth. 56

Steam:

Steam Steam can be produced with the help of boiler. A boiler of adequate size should be installed in accordance with conditions. The boiler should have suitable devices to treat the steam so as to produce the steam of desired quality. 57

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The company has 2 types of steam: the industrial steam for heating purpose and this steam do not come in contact with the products and the clean steam which is generated from sterile water and this steam only is allowed to come in contact with the product. 58

Gases:

Gases Gases are usually available in compressed form in cylinders & are supplied to the desired area through pipelines. Pipelines of different gases should be of different colors & it should be suitably identified. 59

Lighting:

Lighting Adequate light in pharmaceutical unit is necessary. Without it, the workers can not carried out their work satisfactorily. If the work area has less light , it will cause eye strain & fatigue when detailed work is to be performed. Too much light is also not desirable as it can cause glare & dazzle. 60

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Daylight is more preferable to artificial light because eye is more accustomed to natural light . The minimum recommended intensity of light is 500lux. For detailed work , an intensity of 1000lux is required. For adequate lighting, points should be considered are: Position of source of light. Selection of tubes or bulbs. Intensity of light. 61

Air system:

Air system A well designed system for air conditioning not only for heating, cooling and humidity control but also for filtration of air up to 97% particulate free air in non-parental areas and up to 99.97 % particulate free and laminar flow in the controlled environment. The critical processes are carried out in class 100 area with the aid of HEPA filtered air system. It should prevent the entry of air borne contaminants in the working area. 62

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Dust & floating particulate matters should be removed before settling. There should be no turbulence in air. Pressure dampers & diffusers are used to prevent it. Incoming volume of air should be adequate so that particulate contaminants swept into exhaust. 63

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Temperature & humidity should be so controlled that they do not affect the product to be processed & provide comfort to workers. Where aseptic processes are carried out, the air is passed through HEPA filters . To remove dust generated in manufacturing areas, vacuum or other special exhaust system are used. 64

Control of contamination:

Control of contamination Particulate matter either be nonviable or viable (microorganism).To prevent contamination, both types of particulate matters are to be controlled. Measures which are taken to prevent contamination are as follows : When dry materials while processing generate dust, generated dust should be removed by exhaust system either provided in the equipment or installed in the facility. 65

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2) Some contaminants may be hazardous , if not controlled properly . These contaminants include sensitizing materials ( penicillins ) , biological organisms , cytotoxic substances & other highly active materials. Cross contamination of this type should be avoided by technical organization measures which may include : a) Production in dedicated areas. e.g Penicillins 66

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Production by compaign followed by appropriate cleaning. By providing air locks, pressure differentials & air extraction. Minimizing the risk of contamination caused by recirculation or reentry of untreated or insufficiently treated air. Use of protective clothing in areas where production with special risk of cross contamination are processed. Using a closed system of production. 67

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Filtered air is used to reduce particulate matter in the environment. Class of clean air for aseptic operations- class100. For non sterile products, such cleanliness is not required. 68

References:

References “How to practice GMPs”, P.P.Sharma , 3 rd edition, Vandana publications, 164-170. “Quality assurance & Quality management in pharmaceutical industry”, Y.Anjaneyulu, R.Marayya, Pharma book syndicate, 17, 127-128, 156. 3) “Quality assurance of pharmaceuticals”, WHO Geneva, first Indian Reprint 2002, Vol-2, Pharma book syndicate, 28-31. 69

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