buildings and facilities

8/2/2019 Buildings and Facilities

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Quality assuranceof buildings and

facilities.Chakravarthy70211886001

M.Phramacy 1st yeartics)

Gokaraju rangaraju

harmacy


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Contents :Site selectionoverall design conceptplant layoutDesign and construction featuresConstruction materials

lightingair handling systemsplumbing

sewage and refusewashing and toilet facilitiessanitationmaintenance


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Site selection:

The requirements of site selection involve thedesign and layout of the facility which mustminimize the possibility of mix ups orcontamination.

Many governments eager to encourageindustry, offer sites with no local governmenttaxes for first five years and also helps infinancial needs.

Certain regional governments havedeveloped scientific parks.


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It is vital to ensure that localpopulation is behind the siting of thenew industry.Energy and construction costs can

vary, depending on the location ofthe site. Some areas have access tolow cost electricity, natural gas orlocal solid fuels, oil and coal.

Companies tend to locate in areaswhere there is no. of similarindustries.


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Overall design concept:

The execution plan and project stages givenhere for the development of conceptualdesign.Execution plan project stages:

it is done in 4 stages1.Client brief evaluation and assessment2.Process development

3.Conceptual design based on the clientbrief outcome of any previous studies, andfinalized layout4.costing


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These four stages can be divide up, allowing a total period of 13weeksStage1-client brief evaluation, weeks 1 and 2:

a complete evaluation of clients brief to establish the basis ofconceptual design.it will include discussions between the client and the contractors

or consultants key team members.


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Stage 2 process development, week 3to 6

Having fully assessed the clientsideas and requirements theprocess engineer and, if

necessary, a specialist consultantwill develop process design.During week 6 the proposedprocess and sketched layout are

reviewed in depth with client.


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Stage 3 conceptual design, weeks 7 to 10

At the commencement of week 7 thefull team commences full development

of the conceptual design.By the end of the week 10 the conceptis fully defined in drawings,specifications, and written documents.


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Stage 4 cost estimation and document

preparation weeks 11to 13:

The final three weeks of the studycomprises :

preparation of cost estimate.finalization of conceptual

design documentation.


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Plant layout:

Plant layout refers to the arrangement ofphysical facilities such as machinery,equipment, furniture's etc. with in thefactory building such a manner as to havequickest flow of the material at the lowestcost and with the least amount of handling,in processing the product from the receipt

of material to the shipment of the finishedproduct.Importance:Optimum relationship among output, floor

area and manufacturing process.Provides flexibilit of o erations


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Proper and efficient utilization of available floorspace.Provide enough production capacity.Reduce material handlings cost.

Utilize labour efficientlyReduce accidents.Provide ease of supervision and controlAllow ease of maintenance

Allow high machine or equipment utilizationImprove productivity.


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Design and construction

featuresMainly two areas of concern externalenvironment and internal environment

Pertinent consideration prior to purchase:a) Adequate space.b) Availability of water.c) Accessibility for employees, materials and

visitors.d) Environment.e) Security.


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After identified a suitable location ,sitedevelopment plan is prepared and willinclude:

a) laws and regulationsb) Storm water and waste managementc) Site security and access fences, guards

posts, camerasd) Buildings sitting, layout, usage.e) utilities-design, layoutf) Equipment design, layout, sparesg) Traffic flowh) Safety.


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Construction materials

(i)Walls :Position of walls should provide an orderly

movement.

Interrelationship of different operationsshould minimize the cross contamination.

Plaster finish on concrete blocks or gypsumboard.

Finish should be smooth, usually with epoxypaint


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(ii)Floors :Floor covering should be selected for

durability and cleanability.

Terrazzo provides a hard wearingfinish, both tiles and poured-in-place

finishes are available

Terrazzo tile


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Epoxy terrazzo is mainly used, epoxysubstrate which contains either marble orglass chips is first toweled evenly ontothe concrete and then ground andpolished in a number of successive steps.Ceramic and vinyl tiles usually are notrecommended for production areas.Welded vinyl sheets are used inproduction area of injectables


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(iii)Ceilings :Suspended ceilings may be provided inoffice areas, laboratories, toilets and

cafeterias.They usually consist of lay in acoustical

panels.


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(iv)Service:

Provisions must be made for drains,water, electricity, and other services toallow for ease of maintenance.


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Lighting:

Adequate light shall be provided in all areas.Normally a range of 70-100 lux ensures worker comfort and ability toperform efficiently and effectively.200 lux is needed for special areas, such as inspection of filled vials.


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Air handling system:

Equipment for adequate control over airpressure ,micro-organisms, dust, humidityand temperature should be provided

Air filtration include pre filters andparticulate filters.Air handling systems for manufacture,processing and packing of penicillin shall

be separate from those of other drugproduct for human use.


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Placement of air inlet and outlet ports.Recirculation of air.

Alarm system and automatic cut-off systemis used ,where filter develops hole.In aseptic processing HEPA filters are used:

for filling and sealing operations:

a)less than100 particles of 0.5micron or larger,b)not more than one colony

forming organisms per cubic feet.

c)90 feet per minute arerecommended.

d)Requires a filter 99.97% DOPefficiency.


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For solution compounding, equipmentand component preparation:

a) not more than 100,000particles of 0.5 microns or larger

b)not more than 25 colonyforming organisms per 10 cubic feet.


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Plumbing:

Potable water shall meet the standardsprescribed in the Environmental ProtectionAgency's Primary Drinking WaterRegulations set forth in 40 CFR Part 141.

Drains shall be of adequate size and,where connected directly to a sewer, shallbe provided with an air break or othermechanical device to prevent back-siphonage


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Sewage and refuse:

Sewage, trash, and other refuse in andfrom the building and immediatepremises shall be disposed of in a safe

and sanitary manner.A pharmaceutical plant may considerdisposal in several different ways:1. Product disposal

2. Printed packaging disposal3. General trash and sewage


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WASHING AND TOILET

FACILITIESAdequate washing facilities shall beprovided, including hot and cold water,soap or detergent.

In addition to GMP regulations,Occupational Safety & HealthAdministration (OSHA) regulations impacton washing and toilet facilities.


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Sanitation:

Any building used in themanufacture, processing, packing,or holding of drug product shouldmaintain clean and sanitary

condition.There should be writtenprocedures for use of suitableagents.

Manufacturing areas requireregular cleaning and disinfection .


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Create and maintain a safe workingenvironment.

Remove dust and dirt, which can behazard to the quality.Minimize the risks of cross-contamination.Reduce levels of contamination micro-organismsEquipment used for cleaning

floor mopsvacuum cleanersmechanical floor cleanersjet cleaners

In general, the interval between twocleanin ro rams should not exceed 3


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Maintenance:

Deterioration of building not only presentsa poor image of facility, it can also impacton product quality.The ingress of water from roof leaks can

cause damage to materials andequipment.Building inspection and maintenanceprograms should be defined in writing and

record kept for referencing any repairs


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Conclusion:

It dictates the quality and compliance ofproducts that are to be manufactured andtheir profitability over the long run.

Therefore, these activities must beplanned in detail with the end in mindincluding the regulatory requirements forthe types of products according tointended commercial markets in additionto the facilitys country of location


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References:

Q.A manual, buildings and facilities ,B.HShah, page no. 42-67.Pharmaceutical productions facilities,design and management, Graham

c.cole ,page no.13-18.Gmp for pharmaceutical, a plan for totalquality control, sidney H.willling, james R.stoker page no.43-61.


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