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IDEAL PHARMACEUTICAL
FACILITY
PRESENTED BY:
IHSAN ULLAH KHAN KHATTAKChief Manager Production
Highnoon Laboratories Limited17.5 K.M. Multan Road, Lahore, Pakistan.
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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 system•Inadequate utilities layout
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WORLD CLASS PHARMA MANUFACTURING FACILITY DESIGN
TYPES OF MANUFACTURING FACILITY
A.NEW FACILITY- Dedicated premises - Multi product facility
B. UPGRDATION OF EXISTING FACILITY- Modernization- Extension - Expansion
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WORLD CLASS PHARMA MANUFACTURING FACILITY
Components of Facility:
- Shipping / Receiving - Warehouses- Manufacturing Plant- Packaging Areas- Quality Operations- Office Block- Utilities Floor
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WORLD CLASS PHARMA MANUFACTURING FACILITY
DESIGN ISSUESBasic Criteria,- Prevention of Cross contamination- Processing of multiple products
concurrently.- Ensure integrity of final product- Unidirectional flow
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WORLD CLASS PHARMA MANUFACTURING FACILITY
Architectural Design Process
Programming Phase Problem Seeking
Design Phase Problem Solving
Documentation Phase
Construction Phase
Implementation Validation
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WORLD CLASS PHARMA MANUFACTURING FACILITY
SOME IMPORTANT PARAMETERS- LAYOUT - HVAC DESIGN- WATER SYSTEM- AUTOMATION- TYPE OF TECHNOLOGIES
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WORLD CLASS PHARMA MANUFACTURING FACILITY
HVAC Design and Monitoring - Need- First 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 high- Skilled manpower - Hidden variables - Improper air management- Classification of the areas, temperature and
RH- Pressure 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 Technology- Right Equipments- Right Utilities- Right Vendors- Right Time Management- Commitment
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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