premises- plant layout & plant location-pradeepkumar

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PREMISES-PLANT layout & Plant LOCATION:

PREMISES-PLANT layout & Plant LOCATION MAHARASHTRA COLLEGE OF PHARMACY, NILANGA. Prepared by : Guided by: Waghmare Pradeepkumar Virappa Dr. Bhusnure O.G. M. Pharmacy Ist year (QA) HOD, QA Dept., MCP Nilanga

Contents :

Contents 2 Introduction Location , Layout (the arrangement of physical facilities), Designing the product, Production planning and control and maintaining good quality of product. Importance of plant layout Types of plant layout Sample layouts Maintenance plant services, systems and utilities References

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In this lesson study of plant location ,layout and planning. Industry are two type depends on its size and nature. Small scale industry The local market for the product is available. It can easily be shifted to other place, when there is any change in the market. Large scale industry Huge amount of investment has already been done the selection of proper site is very important. 3

Objectives :

Objectives 4 Describe the concepts of plant location and plant layout Identify the various factors to be considered for selection of plant location Distinguish among the alternative patterns of plant layout Discuss the various factors influencing the choice of an initial layout and its subsequent modification

Plant location:

Plant location 5

Location:

Location 6 Plant location Ideal location Selection of a particular site for setting up a business or factory Cost of the product is kept to minimum. It is the place of maximum net advantage or which gives lowest unit cost of production and distribution

Locational analysis:

1. Demographic Analysis : It involves study of population in the area .like Total population (in no.), Age composition, Per capita income, Educational level. Demographic Analysis Trade Area Analysis Competitive Analysis Site economics Traffic analysis Locational analysis

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8 2 . Trade Area Analysis: Geographic area analysis. To provides Continued clientele to the firm. Feasibility of accessing the trade area from alternative sites. 3. Competitive Analysis: It help quality of competition in a given trade area. 4. Traffic analysis: To have a rough idea about the number of potential customers passing by the proposed site during the working hours of the shop. 5. Site economics: Alternative sites are evaluated in terms of establishment costs and operational costs under this. Establishment Cost: is basically cost incurred for permanent physical facilities , Operational costs are incurred for running business on day to day basis, they are also called as running costs .

Importance of selection of plant layout:

Importance of selection of plant layout Heating Ventilation requirements Storage capacity of raw material Power needs , Cost of labours, Taxes, Land construction, fuel, etc. 1.Cost Investment costs 2.Physical factor 3.Gove. rule Choice of location keeping national benefits. Partially determines costs. Operating

Factors responsible for the plant location choices:

Availability of Raw material: Nearness to the potential market: Location should be near to source of operating power: Supply of labour: labour is one of the most important inputs in any industrial enterprise. Transport and communication facilities: connected with rail way, airport, road, water and air transport system is considered Suitability of climate: climatic conditions such as humidity, temperature and other atmospheric conditions should be favourable for the plant. For the example, humid atmosphere is not suitable for the formation of pharmaceutical Factors responsible for the plant location choices

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Availability of housing and services: good housing facility, adequate shopping centre, cinema halls, local transport facilities, rail services and sufficient availability of gas, water supply, disposal of waste, can easily attract good staff. Safety requirements: cause pollution or processes explosives in nature should be located in remote areas. Miscellaneous considerations: The consideration like low interest on loans, special grants, attitude of residents, towards the industry, living standards etc. helps in locating in the site of plants.

Selection of sites:

It should be Connected with rail, road and river transports. Efficient sewage system for the disposal of water and waste materials Surroundings good and peaceful Sub-soil capable of bearing the load of the building plant and equipment. Sufficient land space requirements for the parking of transport and sufficient space for residential accommodation for staff and labour 12 Selection of sites

Selection of sites :

Selection of sites urban areas It near to city. therefore Provide better transport and communication system with sufficient labour supply & also social services like medical, entertainment, restaurants, educational etc. But in urban area, cost of land and labour wages are likely to be on higher side. Rural areas It near to village. therefore provide cheaper land and labour with scope for further expansion, good shopping complexes, entertainment facilities, school and colleges and In general, rural location is good for large plants. 13

Plant location:

A plant should be located at a place where inhabitants are interested in it’s success, the product can be sold profitably and production cost is minimum – DR. Vishweshwarya . A plant location is often result of compromise among conflicting social, economic and geographical conditions – Lansburg . Plant location

The principle factors to be considered for the location of a plant ::

The principle factors to be considered for the location of a plant : Availability of Raw materials Nearness to Potential market Supply of Labour Transportation facilities Availability of Utilities : Water, Fuel, Power Suitability of Climate & Land Local Community Considerations Political Strategic Considerations Environmental Impact, And Effluent Disposal.

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Availability of Raw Materials : The Availability And Price Of Suitable Raw Materials Will Often Determine The Site Location. Plants Producing Bulk Chemicals Are Best Located Close To The Source Of The Major Raw Material. EX: Soda Ash Plant Should Be Located Near The Salt Lakes Or Near Sea, Where Sodium Chloride Is Available Abundantly. Nearness to Potential Market : For Materials That Are Produced In Bulk Quantities: Such As Cement, Mineral Acids And Fertilizers, the Plant Should Be Located Close To The Primary Market.

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Supply of Labour : Local Trade Union Customs And Restrictive Practices Will Have To Be Considered When Assessing The Availability And Suitability Of The Labour For Recruitment And Training. An Adequate Pool Of Unskilled Labour Available Locally. Transportation Facilities : The Transport Of Materials And Products To And From Plant Will Be An Overriding Consideration. If Practicable, A Site Should Be Selected That Is Close to At Least Two Major Forms Of Transport: Road, Rail, Waterway Or A Seaport.

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Availability of Utilities : Water, Fuel, Power : The Word “Utilities” Is Now Generally Used For The Ancillary Services Needed In The Operation Of Any Production Process. Electricity: Power Required For Electrochemical Processes, Motors, Lightings, And General Use. Steam For Process Heating: The Steams Required For The Process Are Generated In The Tube Boilers Using Most Economic Fuel. Water For General Use: The Water Required For The General Purpose Will Be Taken From Local Water Supplies.

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Suitability of Climate & Land : Adverse Climatic Conditions At Site Will Increase Costs. Abnormally Low Temperatures Will Require The Provision Of Additional Insulation And Special Heating For Equipment And Piping. Sufficient Suitable Land Must Be Available For The Proposed Plant And Future Expansion. The Land Should Be Ideally Flat, Well Drained And Have Load-Bearing Characteristics. A Full Site Evaluation Should Be Made To Determine The Need For Piling Or Other Foundations.

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Local Community Considerations: The Proposed Plant Must Fit In With And Be Acceptable To The Local Community. Full Consideration Must Be Given To The Safe Location Of The Plant. So That It Does Not Impose A Significant Additional Risk To The Community. Political And Strategic Considerations: Capital Grants, Tax Concessions, And Other Inducements Are Often Given By Governments To Direct New Investment To Preferred Locations; Such As Areas Of High Unemployment. The Availability Of Such Grants Can Be The Overriding Consideration In Site Selection.

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Environmental Impact, And Effluent Disposal: All Industrial Processes Produce Waste Products, And Full Consideration Must Be Given To The Difficulties And Coat Of Their Disposal. The Disposal Of Toxic And Harmful Effluents Will Be Covered By Local Regulations, And The Appropriate Authorities Must Be Consulted During The Initial Site Survey To Determine The Standards That Must Be Met.

Introduction to plant layout :

22 Plant Layout: Arrangement of physical facilities such as Machinery Equipment furniture etc. within the factory building in such a manner so as to have quickest flow of material at lowest cost & with the least amount of handling in processing the product from the receipt of material to the shipment of finished product. Pilot Plant : It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of practical procedure of manufacture. Scale-up : - The art for designing of prototype using the data obtained from the pilot plant model. Introduction to plant layout

Objectives of plant layout:

Objectives of plant layout 23 Proper and efficient utilization of available floor space. Reduce material handling costs Provide ease of supervision and control. Allow easy maintenance of machines and plant.

Importance plant layout :

Importance plant layout 24 An ideal plant layout should provide the optimum relationship among output, floor area & manufacturing process. Flexibility of operation Easy production flow Make economic use of building Promotes effective utilization of manpower Employee’s convenience Safety Comfort at work Maximum exposure to natural light & ventilation

Importance plant layout :

Importance plant layout 25 Plant layout provide the optimum relationship between output, floor area and manufacturing process. Facilitates of production process, To minimizes material handling, time and cost, and flexibility of operations, easy production flow, makes economic use of the building, promotes effective utilization of manpower, and provides for employee’s convenience, safety, maximum exposure to natural light and ventilation. It is also important because it affects the flow of material and processes, labour efficiency, supervision and control, use of space and expansion possibilities etc.

Essentials :

Essentials 26 Proper and efficient utilization of available floor space. To ensure that work proceeds from one point to another point without any delay. Provide enough production capacity. Reduce material handling costs Reduce hazards to personnel Reduce accidents

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27 Provide for volume and product flexibility Provide for employee safety and health Allow ease of maintenance Allow high machine or equipment utilization Improve productivity Increase employee morale

Types of Layout:

Types of Layout 28 There are 3 types of plant layout: Manufacturing units Product or line layout Process or functional layout Fixed position or location layout Combined or group layout Traders Services Centers And Establishment TYPES OF LAYOUT Self service or modified self service layout Full service layout Special layouts

Manufacturing Units:

Manufacturing Units 29 It divides in to four type Product or line layout Process or functional layout Fixed position or location layout Combined or group layout

Product or Line Layout:

Product or Line Layout 30 Principles: All the machine tools or other items of equipment must be placed at the point demanded by the sequence of operations. There should no points where one line crossed another line. Materials may be fed where they are required for assembly but not necessarily at one point. All the operations including assembly, testing packing must be included in the Line. Machines and equipments are arranged in one line. The materials move form one workstation to another sequentially without any backtracking or deviation. sequence arrangement of operations required for the product. Materials are fed into the first machine and finished goods travel automatically from machine to machine, the output of one machine becoming input of the next, Therefore

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31 Advantages: Low cost of material handling, due to straight and short route and absence of back tracking. Continuous flow of work Lesser investment in inventory and work in progress Optimum use of floor space Shorter processing time or quicker output Less congestion of work in the process Lower cost of manufacturing per unit Smooth and continuous operations Simple and effective inspection of work and simplified production control

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32 Disadvantage: Higher initial capital investment in special purpose machine (SPM) Heavy overhead charges Breakdown of one machine the whole production process are stop. Suitability Mass production of standardized products Lesser flexibility of physical resources. Suitability Mass production of standardized products Simple and repetitive manufacturing process Operation time for different process is equal Continuous supply of materials

Product or Line Layout:

Product or Line Layout 33 Product A Product B Product C Step 1 Step 1 Step 1 Step 2 Step 2 Step 2 Step 3 Step 3 Step 3 Step 4 Step 4 Step 4

Process Layout:

Process Layout 34 Principle The distance between departments should be as short as possible for avoiding long distance movement of materials. The departments should be in sequence of operations. The arrangement should be convenient for inspection and supervision In this type of layout machines of a similar type are arranged together at one place. E.g. Machines performing Compression operations are arranged in the Compression department. Therefore the machines are installed in the plants, which follow the process layout.

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35 Advantages: Lower initial capital investment in machines and equipments. Breakdown of one machine does not result in complete work stoppage Supervision can be more effective and specialized There is a greater flexibility of scope for expansion. There is high degree of machine utilization, as a machine is not blocked for a single product. The overhead costs are relatively low Change in output design and volume can be more easily adapted to the output of variety of products

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36 Disadvantage: Material handling costs are high due to backtracking. More skilled labour is required resulting in higher cost. Work in progress inventory is high needing greater storage space. Needing greater storage space. More frequent inspection is needed which results in costly supervision. Time gap or lag in production is higher Suitability Products are not standardized Quantity produced is small There are frequent changes in design and style of product Machines are very expensive

Process Layout:

Process Layout 37

Process Layout Vs. Product Layout Advantages table:

Process Layout Vs. Product Layout Advantages table Process Layout Sharing of specialized and costly equipments. More flexibility Less vulnerable to breakdown Product Layout Standardized product-process routing Operational control is simpler High output rate is possible

Process Layout Vs. Product Layout Disadvantages table:

Process Layout Vs. Product Layout Disadvantages table Process Layout Large inventory buildup is prevalent. Operational control difficult Excess material handling is required. Product Layout Low tolerance for breakdown. Less flexibility due to dedication of resources Duplication of equipment leads to high cost

Fixed Position or Location Layout :

Fixed Position or Location Layout 40 Principle: In this type of layout, the major product being produced is fixed at one location. Equipment labour and components are not moved to that location. All facilities are brought and arranged around one work centre. In this type of layout, the major product being produced is fixed at one location. Equipment labour and components are not moved to that location. All facilities are brought and arranged around one work center. This type of layout is not relevant for small scale entrepreneur. Advantages: The investment on layout is very small. It saves time and cost involved on the movement of work from one workstation to another. The layout is flexible as change in job design and operation sequence can be easily incorporated Adjustments can be made to meet shortage of materials or absence of workers by changing the sequence of operations .

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41 Disadvantage: As the production period being very long so the capital investment is very high. capital investment is very heavy. Very large space is required for storage of material and equipment near the product. As several operations are often carried out simultaneously, there is possibility of confusion and conflicts among different workgroups. Suitability: Manufacture of bulky and heavy product .

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42 Fixed Position Or Location Layout Raw Material Air Craft Assembly Finished Product (Aircraft) Machines & Equipment Labour

Combined Layout:

Combined Layout 43 Principle: In most of industries, only a product layout or process layout or fixed location layout does not exist. Generally, a combination of the product and process layout or other combinations are found, in practice. E.g. for industries involving the fabrication of parts and assembly, fabrication tends to employ the process layout, while the assembly areas often employ the product layout. In soap, manufacturing plant, the machinery manufacturing soap is arranged on the product line principle, A combination of process & product layout is known as combined layout. Manufacturing concerns where several products are produced in repeated numbers with no likelihood of continuous production, combined layout is followed

Traders:

Traders 44 When two outlets carry almost same merchandise, customers are attracted and kept by good layout. i.e. Good lighting, Attractive colours, Good ventilation, Air conditioning, Modern design. All of these things mean customer convenience, customer appeal and greater business volume. There are three kinds of layouts in retail operations today. Self service or modified self service layout Full service layout Special service layouts

Services Centers And Establishment:

Services Centers And Establishment 45 Services establishments, must give due attention to customer convenience, quality of service, efficiency in delivering services

Advantages of a good layout:

Advantages of a good layout 46 1. To the worker: Decreasing number of operation and material handling. reduction in length of hauls and motions between operations, which minimize production time as well as the activities of workers. more labour productivity i.e. more output per man hour. more safety and security to workers from accidents. Better working conditions resulting in improved efficiency. 2 . In manufacturing costs: Maintenance and replacement costs are reduced. Loss due to waste and spoilage is minimised . Improved quality of product with reduction in handling , time and cost. Better cost control.

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3. In production control and supervision: provides more space for production operation. Easy Availability of Raw material. The cost of production are minimized. Control and supervision operations are provided at appropriate points 47

Features of good layout:

There should be sufficient space for the workers as well as for the equipment to perform their functions. This will ensure smooth and continuous flow of production process. It must provide adequate safety and security to workers against accidents or injury. For example, provision of firefighting equipment, first aid boxes, etc. The arrangement of machines and equipment should be such that minimum material handling is necessary for low cost processing. The store for in-process material should be such that minimum material handling is necessary for low cost processing. The supervision, coordination and control of the activity should be effectively and easily executed. 48 Features of good layout

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There should be sufficient scope for making adjustment and modifications whenever any need arises. Good cGMP Design Features Include: Clear layouts Appropriate detailing and finishes Adequate room sizes and staging areas Flexibility: Able to adapt to different uses Able to bring new services to the rooms Ease off clean up Modulations 49

Factors influencing layout:

Factory building: determines the floor space available for layout & special requirements such as.. air conditioning, dust control, humidity control etc. must be kept in mind. Nature of product: product layout is suitable for uniform products whereas process layout is more appropriate for custom-made products. Production process: In assembly line industries, product layout is better. In job order or intermittent manufacturing on the other hand, process layout is desirable. Type of machinery: General purpose machines are arranged as per process layout while special purpose machines are arranged according to product layout 50 Factors influencing layout

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Repairs and maintenance: Machines should be arranged that adequate space is available between equipment & easy to repairs the machines. Human needs: Adequate arrangement should be made for washroom, lockers, drinking water, toilets and other employee facilities, proper provision should be made for disposal of effluents, if any. Plant environment: Heat, light, noise, ventilation and other aspects should be duly considered, e.g. paint shops and plating section should be located in another hall so that dangerous fumes can be removed through proper ventilation etc.

Applicability of plant layout:

Plant layout is applicable to all types of industries or plants. Certain plants require special arrangements discussed above. Applicability of plant layout in manufacturing and service industries is discussed below. Ex: manufacture of talcum powder. Here machinery is arranged vertically i.e. from top to bottom. Thus, material is poured into the first machine at the top and powder comes out at the bottom of the machinery located on the ground floor. Generally, the receiving and the dispatching departments should be at either end of the plant & order to minimize handling costs .The storeroom should be located close to the production. 52 Applicability of plant layout

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The maintenance department consisting of lighting, safety devices, fire protection, collection and disposal of garbage, scrap etc. should be located in a place which is easily accessible to all the other departments in the plant. The other employee facilities like toilet facilities, drinking water facilities, first aid room etc. can be a little away from other departments but should be within easy reach of the employees. 53

Sample Layout for Pharma Industry:

Sample Layout for Pharma Industry 54 SAMPLE LAYOUT OF A PRODUCTION DEPARTMENT SAMPLE LAYOUT OF F&D DEPARTMENT

Space required as per Schedule-M:

Space required as per Schedule-M 55 Oral liquid 30 M 2 basic installation+ 10 M 2 ancillary Semi solid preparation 30 M 2 + 10 M 2 for ancillary Granulating section 30 M 2 Solid dosage form compression section 30 M 2 + 20 m 2 ancillary Coating 30 M 2 + 10 m 2 ancillary Powder 30 M 2 Filling of hard gelatin cap. 25 M 2 + 10 M 2 ancillary Parenteral preparation Total 150 M 2 mfg. area+ 20 m 2 ancillary svp or 150 M 2 for lvp Aseptic Filling and sealing Filling and sealing General room Eye ointmennt. And eye lotion 25 M 2 + 10 m 2 ancillary Suppositories 30 M 2

Ancillary layout:

Ancillary layout 56

PREMISES:

PREMISES 57 Principle Premises must be located, designed, constructed, adapted and maintained for the operations: Minimize risk of errors & cross- contamination Permit effective cleaning Permit effective maintenance Minimize build-up of dirt and dust Eliminate any adverse effects on quality

PLANT SERVICES, SYSTEMS AND UTILITIES :

PLANT SERVICES, SYSTEMS AND UTILITIES A manufacturing facility, built and finished as designed, still requires various other inputs, in addition to people, equipment, and materials, before the manufacture of products can begin. These can be referred to collectively as “plant services,systems, and utilities.” 58

UTILITITIES & SERVIES :

UTILITITIES & SERVIES 1. Water supply systems Identify and interpret regulatory requirements for design of water supply systems, including various unit operations (e.g., dechlorination , reverse osmosis, deionization, distillation, etc.), delivery lines, back-flow or back-siphonage prevention, and drainage systems, as appropriate for the type of water (potable, purified, water for injection, etc.) needed in various processing steps. 2. Compressed air and gas systems Identify and apply regulatory requirements related to compressed air and gas systems, including storage, flow regulation, filtration, venting and purging, etc. 59

WATER:

WATER Objectives To examine the basic technology and requirements for: Water treatment systems Storage requirements Sampling and t esting Different types of water used in pharmaceuticals Microbial limits, disinfection 60

Water system design :

Water system design Pipes sloped so water does not pool and can drain easily Sanitary fittings & connections Constructed of suitable materials such as stainless steel Circulate the water Incorporate non-return valves (NRV) 61

Water system design (1):

3. The water is contaminated as it passes through the valve 2. Bacteria can grow when the valve is closed 1 . Ball valves are unacceptable Stagnant water inside valve Water system design (1) 62

Water system design (2):

Water system design (2) 63 Sanitary pumps Clamp s and O rings versus threaded fittings Heat exchangers Side arm level measuring devices are unacceptable

Water:

Water For pharmaceutical purposes, it may be considered that there are three basic grades of water : Potable Water Purified Water Water for Injections 64

Potable Water :

Potable Water Potable water may be used in chemical synthesis and in the early stages of cleaning pharmaceutical manufacturing equipment unless there are specific technical or quality requirements for higher grades of water. It is the prescribed source feed water for the production of pharmacopoeial grade waters. 65

Water for Injections :

Water for Injections International pharmacopoeia requirements for WFI are those for purified water plus it must be free from pyrogens Usually prepared by distillation Storage t ime should be less than 24 hours Microbial limits must be specified 66

Purified Water :

Purified Water Purified Water is water for the preparation of medicinal products other than those that require the use of water which is sterile and/or apyrogenic . Purified Water which satisfies the test for endotoxins may be used in the manufacture of dialysis solutions. 67

Water:

Water Further water treatment purification stages downstream of the pre-treatment system Filtration Disinfection Reverse osmosis or de-ionization Distillation or ultra-filtration 68

Ultra-filtration :- Can be used for WFI or for Water For Final Rinsing for parenteral manufacturing (if permitted) Removes organic contaminants, such as endotoxins Operation at 80°C, and sterilization at 121 °C   :

Ultra-filtration :- Can be used for WFI or for Water For Final Rinsing for parenteral manufacturing (if permitted) Removes organic contaminants , such as endotoxins Operation at 80°C , and sterilization at 121 °C 69

Distillation :

Distillation Single-effect distillation simple distillation, single effect vapour compression, thermo compression Multi effect distillation multiple effect stills Clean steam generators • used where steam can come into contact with product contact surfaces, e.g. sterilization-in-place (SIP) 70

Gases / Compressed Air :

Gases / Compressed Air Many types of gases are utilized in the manufacturing process. Most prevalent of these include compressed air use in process and controls, breathing air for hazardous envirnments , nitrogen, vaccum , vaccum cleaning, natural gas, propane, and other process system All gases used in manufacturing and processing operations including the sterilization process, should be steriled filtered at point of use to meet the requirements of the specific area. 71

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Gases supplied in cylinders should be properly color coded in accordance with the relevant national or international standard, and additionally identified as to lot or cylinder number. Cylinders should be stored under cover, without exposure to extremes of temperature. Storage conditions should ensure that their markings remain clearly visible. Pressure gauges should be regularly checked and calibrated. 72

Maintenance of sterile areas:

Maintenance of sterile areas For sterile drugs separate enclosed area specially designed for the purpose shall be provided Area shall be provided with air lock for entry & shall be essentially dust free & ventilate with air supply For all area where aseptic manufacture has to be carried out air supply shall be at a pressure higher than in the adjacent area 73

Maintenance of sterile areas:

Maintenance of sterile areas Routine microbial count of all sterile area shall be carried out during manufacturing operation Area where manufacturing progresses going on that area must not be occupied by access people Special procedure should be followed for entering & leaving the manufacturing area 74

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Facilities: Air Lock Permits the passage of objects and people into a cleanroom . Consists of two airtight doors in series which do not open simultaneously. Spray down materials with 70% IPA before placing in the airlock 75

Facilities: HEPA Filters:

Facilities: HEPA Filters High Efficiency Particulate Air Minimum particle collection efficiency: 99.97% for 0.3 µm diameter particles. Disposable Filter made of pleated borosilicate glass 76

References :

References 77 Pharmaceutical Production Facilities Design and Applications Cole Graham c. Taylor & Francis e-Library, 2 nd Edition, 2003, page no: 25-30. Encyclopaedia of pharmaceutical technology, James swarbrick , Informa Healthcare USA,3 rd edition, Vol-5, page no: 2879. Pharmaceutical Jurisprudence, G. K. Jani, Atul prakashan, 7 th edition, 2008-2009 , page no:102 . Good design practices for GMP Pharmaceutical facilities, Terry Jacobs, Adrew A . singore , vol-146, page no: 41-42 Pharmaceutical Industrial management, Mehta R.M, 3 rd edition , page no: 70-90. Pharmaceutical Quality assurance by Manohar A. Potdar , Nirali Prakashan , Second Edition 2010 www. who.int Good Pharmaceutical Manufacturing Practice Rationale and Compliance, John Sharp Quality assurance Manul by Pier Components, LLC UNOPS- Quality Assurance Manual for Pharmaceutical and Medical Device Procurement July 2012

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