Building and facility GMP premises

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PREMISES: LOCATION, DESIGN, PLANT LAYOUT, CONSTRUCTION MAINTANANCE AND SANITATION:

PREMISES: LOCATION, DESIGN, PLANT LAYOUT, CONSTRUCTION MAINTANANCE AND SANITATION GUIDED BY : PREPARED BY: Dr. N.J. SHAH VAIPA N. PATEL Principal M. Pharm (QA), 1st Sem., Roll No:2 Year: 2010-11 DHARMAJ DEGREE PHARMACY COLLEGE Q.A.DEPARTMENT DHARMAJ M-Pharm I = 2010 - 11 D. D. P. C.

CONTENTS::

CONTENTS: Site selection. Overall design concept. Plant layout. -Definition. -Importance. -Essentials. -Types of layout. -Factors Influencing Layout. -Dynamic of plant layout. 2

 Premises - Principle - Ancillary areas - Storage areas - Production areas - Quality control areas  Building & facilities - Design & construction features - Lighting:

 Premises - Principle - Ancillary areas - Storage areas - Production areas - Quality control areas  Building & facilities - Design & construction features - Lighting 3

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-Ventilation, Air Filtration, Air Heating & cooling. - Plumbing. - Sewage & Refuse. - Washing & toilet Facilities. - Sanitation. - Maintenance.  Reference. 4

Site Selection Neighbours What do they do? What impact can they have on the business? What steps need to be taken in selecting this new site? 1) The development of a business plan which will define the objectives of the management team & the goals of the production staff (management by objective, MBOs). Each group will provide a list of their needs. 2) The resulting final project goals are the culmination of all this discussions and should be used by management to arrive at a final decision. Of course, events can always overtake the best decisions, so there has to be built-in frame work of flexibility. :

Site Selection Neighbours What do they do? What impact can they have on the business? What steps need to be taken in selecting this new site? 1) The development of a business plan which will define the objectives of the management team & the goals of the production staff (management by objective, MBOs). Each group will provide a list of their needs. 2) The resulting final project goals are the culmination of all this discussions and should be used by management to arrive at a final decision. Of course, events can always overtake the best decisions, so there has to be built-in frame work of flexibility. 5

Economic Evaluation: There are the large multinational conglomerates whose main products have certain common characteristics: 1) They originate from research in their own laboratories. 2) They originate from research conducted in universities. 3) They have been licensed from another multination. 4) Their volume is low. 5) They have good profit margins.:

Economic Evaluation: There are the large multinational conglomerates whose main products have certain common characteristics: 1) They originate from research in their own laboratories. 2) They originate from research conducted in universities. 3) They have been licensed from another multination. 4) Their volume is low. 5) They have good profit margins.

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WHAT ARE TAX INCENTIVES? Many governments eager to encourage industry offer sites with no local government taxes for the first five years operation, give grants for buildings, and help with salaries over an initial period. Where a company is changing its location within a country’s borders, then many authorities offer incentives to move in to local unemployment black sports. Certain regional governments have developed scientific parks located near universities of technical excellence for prestige & high technology companies. It is vital to ensure that the local population is behind the siting of the new industry

 Energy and construction costs can vary, depending on the location of the site. Some area have access to low cost electricity, natural gas, or local solid fuels oil & coal.  When a company has decided to move to a completely new location and has decided on the site from an economic view point then the question of a suitable staffing level must be addressed. Companies tend to locate in areas where there are a number of similar industries. :

 Energy and construction costs can vary, depending on the location of the site. Some area have access to low cost electricity, natural gas, or local solid fuels oil & coal.  When a company has decided to move to a completely new location and has decided on the site from an economic view point then the question of a suitable staffing level must be addressed. Companies tend to locate in areas where there are a number of similar industries. 8

OVER ALL DESIGN CONCEPT The execution plan and project stages is given here for the development of conceptual design. Execution Plan Project Stages : There are four stages: 1) Client brief evaluation and assessment. 2) Process development. 3) Conceptual design based on the client brief, outcome of any previous studies, and finalized layout. 4) Costing.:

OVER ALL DESIGN CONCEPT The execution plan and project stages is given here for the development of conceptual design. Execution Plan Project Stages : There are four stages: 1) Client brief evaluation and assessment. 2) Process development. 3) Conceptual design based on the client brief, outcome of any previous studies, and finalized layout. 4) Costing.

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These four stages can be divided in to total period 13 weeks Stage 1 –Client brief evaluation, Week 1 and 2. A complete evaluation of the client’s brief to establish the basis of the conceptual design. It will include discussions between the client and the contractors or consultants key team members, for example the process engineer and architect Stage 2 – Process development, Weeks 3 to 6 Having fully assessed the client’s ideas and requirements the process engineer and, if necessary, a specialist consultant. During this period assistance will be provided on a part time bases by other specialist groups. During week 6 the proposed process and sketched layout are reviewed in depth with the client. Alternatives are then considered.

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Stage 3 – Conceptual design, Weeks 7 to 10 At the commencement of week 7 the full team commences full development of the conceptual design. The scope of the work to be carried out and the deliverable items are defined at this stage. By the end of week 10 the concept is fully defined in drawing, specifications, and written documents. Stage 4 – Cost estimation and document preparation, weeks 11 to 13. The final three weeks of the study comprises : Preparation of cost estimate. Finalization of conceptual design documentation.

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PLANT LAYOUT Definition: Plant layout refers to the arrangement of physical facilities such as machinery, equipment, furniture etc. with in 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. 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

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Essentials: An efficient plant layout is achieved by the following objectives: Proper & 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. Utilise labour efficiently. Increase employee morale. Provide for volume & product flexibility. Reduce accidents. Provide ease of supervision & control. Provide for employee safety & health. Allow ease of maintenance. Allow high machine or equipment utilization. Improve productivity.

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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 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.

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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 a similar type 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.

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d) Combined or group layout Certain manufacturing units may required all three processes namely intermittent process (job shops), the continuous process (mass production shops) and the representative process combined process (i.e. miscellaneous shops)

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Factors Influencing Layout: a) Factory building: The nature and size of the building determines the floor space available. e.g. air conditioning, dust control, humidity control etc. Must be kept in mind. b) Nature of product: product layout is suitable for uniform products whereas process layout is more appropriate for custom-made products. c) Production process: In assembly line industries, product layout is better. In job order process layout is desirable. d) Type of machinery: General purpose machines are often arranged as per process layout while special purpose machines are arranged according to product layout. e) Repairs and maintenance: machines should be so arranged that adequate space is available between them. f) Human needs: Adequate arrangement should be made for cloakroom, washroom, lockers, drinking water, toilets and other employee facilities, g) Plant environment: Heat, light, noise, ventilation & other aspects should be duly considered, e.g. paint shops & plating section should be located in another hall so that dangerous fumes can be removed through proper ventilation etc.

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Dynamics of plant layout: Plant layout is a dynamic rather than a static concept meaning thereby if once done it is not permanent in nature rather improvement or revision in the existing plant layout must be made by keeping a track with development of new machines or equipment, improvements in manufacturing process, changes in materials handling devices etc. Revision in plant layout may become necessary on account of the following reasons: a) Increase in the output of the existing product b) Introduction of a new product and diversification c) Technological advancements in machinery, material, processes, product design, fuel etc. d) Deficiencies in the layout unnoticed by the layout engineer in the beginning.

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Design Principles Keep in mind: - Material flow - People flow - Process flow Ensure logical flow of these activities in designing the premises

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Maintenance and repair - Activities inevitable in manufacturing area - Should present no risk to product Whenever possible, all planned maintenance outside normal operating hours Emergency work in working area followed by thorough clean down and disinfection before manufacturing recommences Area clearance by QA/QC

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Specific areas Ancillary areas Storage areas Weighing areas Production areas Quality control areas Ancillary Areas Rest and refreshment rooms separate from manufacturing and quality control areas Changing, washing and toilet areas accessible and appropriate numbers Maintenance workshops separated from production -if not possible – tools in reserved areas Animal houses well isolated – separate air handling and entrance

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Storage areas - 1 Storage areas of sufficient capacity Orderly storage of categories of materials and products Separate and segregated areas: starting materials, packaging materials, intermediates, bulk, finished products, quarantined, released, rejected, returned and recalled products and materials.

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Storage areas - 2 Appropriate temperature and relative humidity conditions within defined limits Provided, controlled, monitored and recorded Good storage conditions: clean, dry and appropriate lights Storage areas - 3 Quarantine area: clearly marked and access restricted A separate sampling area is the norm: no risk for contamination or cross-contamination Segregated areas for rejected, recalled and returned materials and products Safe and secure areas for highly active, radioactive material s, narcotics and other materials (risk of abuse, fire, explosion)

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

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

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Production areas -2 Layout in accordance with sequence of production Appropriate cleanliness level Adequate work and in-process storage space Orderly and logical positioning of equipment minimizes risk of contamination, mix-ups and missing production steps Specially designed areas for packaging Layout to avoid mix-ups and cross-contamination 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 permitted Disinfection if needed

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Production areas - 4 Design of pipe work, light fittings, and ventilation points no recesses that are difficult to clean Access for maintenance from outside production areas Drains of adequate size, and equipped to prevent backflow Open channels avoided

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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 – also external environment Control of temperature and relative humidity where necessary Regular monitoring of conditions during production and non-production periods

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Quality Control areas QC laboratories should be separate from production areas Separate areas for biological, microbiological and radioisotope methods Suitable design with sufficient space to avoid mixups and cross-contamination Suitable space for storage samples, reference standards, solvents, reagents and records

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BUILDING AND FACILITIES Design and Construction Features: Regarding building and facilities, there are two major areas of concern; the external environment and the internal environment. The external environment must be amenable to the location of well-designed and constructed building. consideration prior to purchase, construction, or alteration of existing facilities includes the following: 1. Adequate space for further expansion. 2. Availability of water power, fuel, sewage and waste-stream removal. 3. Accessing for employees ,material, and visitors (customers, suppliers). 4. Environmental issues such as site history; soil, water and air quality; and geological and topological issues. 5. Availability of a suitable labour force . 6. Ability to provide adequate security arrangement. 7. Political situation – government stability, trade policies and taxation, financial incentives.

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A suitable location for the facility, the site development plan is prepared and will include: 1. Appropriate laws and regulations and any additional company standards. 2. Site resources and infrastructure such as amenities, green spaces, parking, road and rail access, recreation areas, site utilities, tank farms and other external storages. 3. Storm water and waste management. 4. Site security and access – fences, guard posts, cameras. 5. Building - sitting, layout, usage, function interrelationships for efficiency, possible expansion, surface finishes. 6. Utilities – design, layout, backup. 7. Equipment design, layout, spares, capacity. 8. Traffic flow – pedestrian and vehicular (internal and external) 9. Safety for personnel and equipment, containment for hazardous materials. 10. Ease of maintenance – accessibility to services (service ducts), ease of cleaning, access for equipment. 11. Selection and use of experienced contractors. 12. Identification of project management responsibility. 13. Validation plans and an effective change control procedure. 14. Construction materials:

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a ) Walls: The position of walls should provide an orderly movements of material and personnel & should also take into account noise levels Walls in manufacturing areas, corridors, and packaging areas should be of plaster finished on high quality concrete blocks or gypsum board. The finish should be smooth usually with enamel or epoxy paint. b) Floors: i) Terrazzo provides a hard wearing finis, both tiles and poured in place finishes are available. The later is preferable for manufacturing areas and if tiles are used care must be taken to ensure effective sealing between the tiles ii) Ceramic and vinyl tiles are not recommended for production areas. iii)Welded vinyl sheeting provides an even, easy to clean surface. This is not practical for heavy traffic areas, but can be of value in production areas, specially for injectables. iv) Epoxy flooring provides a durable and readily cleanable surface.

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C) Ceilings : Suspended ceilings may be provided in office areas, laboratories, toilet, and cafeterias. They should be nonbrittle, nonfriable, nonasbestos, and non-combustible material. D) Services : In the building design, provisions must be made for drains, water, steam, electricity, and other services to allow for ease of maintenance. Operations shall be performed within specially defined areas of adequate size. There shall be separate or defined areas or other such control system for the firm’s operation as area necessary to prevent contamination or mix ups during the course of the following procedures. 1 Receipt, identification, storage and withholding from use of components, drug product containers, closures and labeling pending the appropriate sampling, testing, or examination by the quality control unit. 2 Holding rejected, components, drug product containers closures and labeling before disposition. 3 Storage of release procedure , drug product containers, closures and labeling 4 Storage of in process materials. 5 Manufacturing and processing operations 6 Packaging and labeling operations 7 Quarantine storage before release of drug product 8 Storage of drug product after release 9 Control and laboratory operations

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Aseptic processing, which includes as appropriate: 1 Floors, walls and ceilings in sterile suites are subject to intensive and frequent cleaning and sanitization,. They should be resistant to aberration not shed particles, be free from holes, crevices, and cracks be sufficiently flexible to accommodate building, strains and be impervious to water and cleaning and the sanitization solution. 2 Temperature and humidity need to be controlled primarily for comfort of operators. Conditions in order of 68◦F and 45 %RH relative humidity have been found to be suitable. 3 In aseptic processing air is provided by way of high efficiency particulate air filters (HEPA) . air is supplied with less than 100 particles of 0.5 microns or larger and with not more than 1 colony forming organism per 10 cubic feet. Airflow of about 90 feet per minute are recommended. Other areas associated with aseptic processing include solutions, compounding, equipment and component preparation, personnel changing and gowning. For these air with not more than 100,000 particles of 0.5 micron or larger and not more than 25 colony forming organisms per 10 cubic feet is acceptable. 4 Cleaning and disinfection of aseptic facilities and equipment are of obvious importance especially in the critical areas. Residual amount of any cleaning or disinfectant agents should be at all acceptable low level. After cleaning and disinfecting rooms and equipments must be maintained in such a manner that this conditions are not impaired.

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LIGHTING: Adequate lighting should be provided in all area. Adequate lighting may be done by defining the amount of light reaching the working surface for each area involved in the production of pharmaceuticals. A range of 30-50 foot candles ensures worker comfort & ability to perform efficiently; however, 100 foot candles may be needed in some areas, as well as special lighting for some operations, such as inspection of filled vials. Ventilation, Air Filteration, Air Heating & Cooling: (a) Adequate ventilation shall be provided. (b) Equipment for adequate control over air pressure, micro organisms, dust, humidity, & temperature shall be provided (c) Air filtration systems, including prefilters & particulate air filters, shall be used. If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production.  Air handling systems should consider the following factors; 1 Placement of air inlet & outlet ports. There should be sited to minimise the entry of airborne particulates. 2 Where recirculation of air is acceptable, adequate precautions must be taken to ensure that particulates from a processing area are removed. This will usually require an alarm system or an automatic cutoff in the event that a filter develops a hole. 3 The degree of filtration & the air volumes should be matched to the operations involved. 4. Temperature & humidity conditions should provide personnel comfort.

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Plumbing: Portable water shall be supplied under continuous positive pressure in a plumbing system. Drains shall be of adequate size, & where connected directly to a sewer, shall be provided with an air break or other mechanical device to prevent back-siphonage. Sewage and Refuse: Sewage, trash, & other refuse in & from the building & immediate premises shall be disposed of in a safe & sanitary manner. A pharmaceutical plant may consider disposal in several different ways: 1) Product disposal. Any product requiring disposal should initially be separated from its packaging if appropriate. Tipping of product to bulk or crushing would be viable pretreatments. 2) Printed packaging disposal: The disposal of printed packaging components including labels, inserts, & cartons poses no health risk. However, ineffective disposal, such as into public landfill, can give rise to public concern that product may be associated with the packaging. Such materials should preferably be incinerated. 3) General trash & sewage. Normal local services will usually be adequate for trash & sewage. However, internal procedures should be sufficiently rigorous & monitored, to ensure that product & packaging waste dose not get intermixed.

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Washing & Toilet Facilities: Adequate washing facilities shall be provided, including hot & cold water, soap & detergent, air driers or single-services towels, & clean toilet facilities easily accessible. (1) Eating facilities: a) Eating & drinking are permitted only in separate eating facilities well segregated. Smoking is permitted only where an adequate disposal device is provided. b) Prominent signs indicating these rules are posted at entrances to production areas. c) Enforcement procedures against violators are taken by management. d) Permanent facilities for breaks & people bringing lunches are required. (2) For production & materials processing areas: a) Drinking, eating, smoking, tobacco chewing, & expectoration are prohibited. b) Tissues & closed disposal containers are readily available .

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(3) Lavatories & lockers: a) Adequate in number for the number of personnel employed. b) Conveniently located to all areas. c) Hot shower facilities are provided. d) Disinfectant soaps are utilised. e) Adequate ash & waste receptacles are provided. g) Follow-up inspection by supervisory personnel is logged. h) Specific rest areas for female employees are provided. i) Eating & drinking are not permitted. Food & beverages for meals & breaks may be stored only in lockers & then removed to a separate eating area. j) Areas separated from all aseptic spaces by an air lock.

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Sanitation: General Maintenance: Buildings, fixtures & other physical facilities of plant shall be maintained in a sanitary condition & shall be kept in repair sufficient to prevent food from becoming adulterated. Cleaning & sanitizing of utensils & equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces or food packaging materials. Toxic materials: 1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be safe and effective under condition of use. Only the following toxic materials may be used or stored in a plant where food is processed or exposed. Those required to maintain clean and sanitary condition. Those necessary for use in laboratory testing procedures. Those necessary for plant and equipment maintenance and operation. Those necessary for use in plant’ operation. 2) Toxic cleaning compounds, sanitizing agents, and pesticide chemical shall be identified, held and stored in a manner that protects against contamination of a food contact surfaces, or food packaging materials.

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Animal and Pest control No animals or pest shall be allowed in any area of a food plant, guard dogs or support animals may be allowed in some areas of a plant Effective measures shall be taken to exclude pests from processing areas Maintenance: Any building used in manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair. Cracks & holes in walls, floors, or ceilings can provide access for insects, rodents, birds, dirt or micro organisms. They can also hinder cleaning & sanitation, thereby increasing the potential for cross contamination or microbial multiplication. Floor cracks can also become a safety hazard for people The images of water from roof leaks can cause significant damage to materials & equipment, give rise to electrical failures & fires holes in the roof or near the tops of buildings provides ready access to birds, which may then be encouraged to nest within the building

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REFERANCES - GMP for Pharmaceuticals, A Plan for total quality control, Sidney H. Willig, James R. Stoker, 4th edition , Marcel decker Inc. Page no. 43-61 - Guidelines on cGMP and Quality of Pharmaceuticals products, S. Iyer, D.K. Publication . Mumbai, 1st edition, 2003, Page no. 207-11, 294-97 - Pharmaceutical Production Facilities- Design & Application, Graham C. Cole, CRC Press, New York, 2nd edition Page no. 17-9, 25-7 - www.ohioagriculture.gov/pubs/divs/food/curr/regulations - www.fda.gov/cder/guidence - www.bushusejyaku.co.jp/eng/facilities_equipment/layout .html

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57 Thank You /58

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