2-Ideal Pharmaceutical Factory
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Transcript of 2-Ideal Pharmaceutical Factory
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IDEAL PHARMACEUTICAL FACILITYPRESENTED BY:IHSAN ULLAH KHAN KHATTAKChief Manager ProductionHighnoon Laboratories Limited17.5 K.M. Multan Road, Lahore, [email protected]
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WORLD CLASS PHARMACEUTICAL FACILITY WHAT IS THE NEED?
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WORLD CLASS PHARMA MANUFACTURING FACILITY PRESENT SCENARIO : The Globalization & Open Market Policy has proved to be a boon for the industries, but has generated need for a globally acceptable manufacturing facility.
There are many flourishing manufacturing facilities, but not all are in compliance with the various regulatory standards.
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WORLD CLASS PHARMA MANUFACTURING FACILITY NEED: FOR A FACILITY Rapid change in manufacturing technology & various regulatory compliances to upgrade for better solution in line with cGMP.
With globalization, the need for compliant facility has become a statutory necessity.
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WORLD CLASS PHARMA MANUFACTURING FACILITY PRESENT SCENARIO: Many existing facilities have ;Inadequate process layout.Inadequate space.Inadequate hygiene & sanitary conditions.Inadequate HVAC systemInadequate utilities layout
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WORLD CLASS PHARMA MANUFACTURING FACILITY DESIGN TYPES OF MANUFACTURING FACILITY
A.NEW FACILITYDedicated premises Multi product facility
B. UPGRDATION OF EXISTING FACILITY-ModernizationExtension Expansion
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WORLD CLASS PHARMA MANUFACTURING FACILITY Components of Facility:Shipping / Receiving WarehousesManufacturing PlantPackaging AreasQuality OperationsOffice BlockUtilities Floor
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WORLD CLASS PHARMA MANUFACTURING FACILITY DESIGN ISSUESBasic Criteria,Prevention of Cross contaminationProcessing of multiple products concurrently.Ensure integrity of final product-Unidirectional flow
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WORLD CLASS PHARMA MANUFACTURING FACILITY Architectural Design ProcessProgramming PhaseProblem SeekingDesign PhaseProblem SolvingDocumentation PhaseConstruction PhaseImplementation Validation
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WORLD CLASS PHARMA MANUFACTURING FACILITY SOME IMPORTANT PARAMETERSLAYOUT HVAC DESIGNWATER SYSTEMAUTOMATIONTYPE OF TECHNOLOGIES
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WORLD CLASS PHARMA MANUFACTURING FACILITY HVAC Design and Monitoring - NeedFirst cost is about 20% of the project cost.Energy consumption is very high about 40% load is HVAC.Validation cost is very high.Maintenance cost is very highSkilled manpower Hidden variables Improper air managementClassification of the areas, temperature and RHPressure Differential, air distribution
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WORLD CLASS PHARMA MANUFACTURING FACILITY Water Management-Potable Water-Purified Water-WFI-Generation and distribution
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WORLD CLASS PHARMA MANUFACTURING FACILITY Project Team-Plant Manager-Mechanical Engineer-Project Engineer-Logistics Engineer-Civil Engineer-Highly Skilled ConsultantA smaller team is definitely a better team.
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WORLD CLASS PHARMA MANUFACTURING FACILITY Incomplete Design-Incorrect piping size -Incorrect wiring -Missing Signal Feeds-Incorrect power supply-Under capacity AHUS-Over capacity AHUS-Improper dehumidification-Improper process flow These are few common mistakes.
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WORLD CLASS PHARMA MANUFACTURING FACILITY Proper Layout DesignSome common mistakes;-Under / over designing of areas.-No provision for waste disposal-Inadequate service areas-Under / over capacity warehouses-Insufficient Holding areas
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WORLD CLASS PHARMA MANUFACTURING FACILITY Cross Contamination Can be Prevented by :
-Proper Layout-Proper Area Classification -Proper HVAC Design-Correct Man & Material Flow-Proper Air Distribution-Skilled Manpower-Technical Awareness.
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WORLD CLASS PHARMA MANUFACTURING FACILITY Future Requirements :-Space -Machine Capacities-Utility Design-Durable Civil Work-Modular Structures -Flooring -Expansion of Product Mix
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WORLD CLASS PHARMA MANUFACTURING FACILITY Proper Communication :-Communication is the key to success as it is not an ancient oriental philosophy or even recently developed success habit, but a well documented but often over looked fact of project team.
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WORLD CLASS PHARMA MANUFACTURING FACILITY Operating Cost Criteria :Selection of right TechnologyRight EquipmentsRight UtilitiesRight VendorsRight Time ManagementCommitment
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WORLD CLASS PHARMA MANUFACTURING FACILITY Summation :Ready to use solutions for Pharmaceutical plant do not exist because user requirement such as product design and quantities, production process vary from case to case.
-Thus pharmaceutical plants cannot be taken off the shelf.
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Thank You