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IDEAL
PHARMACEUTICAL
FACILITY
PRESENTED BY:

IHSAN ULLAH KHAN KHATTAK
Chief Manager Production
Highnoon Laboratories Limited
17.5 K.M. Multan Road, Lahore, Pakistan.
khattak@highnoon.com.pk

WORLD CLASS PHARMACEUTICAL FACILITY WHAT IS THE NEED? .

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 .

•With globalization. the need for compliant facility has become a .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.

•Inadequate HVAC system •Inadequate utilities layout . •Inadequate hygiene & sanitary conditions.WORLD CLASS PHARMA MANUFACTURING FACILITY PRESENT SCENARIO: Many existing facilities have . •Inadequate space. •Inadequate process layout.

UPGRDATION OF EXISTING FACILITY .Dedicated premises .Extension . NEW FACILITY .Modernization .Multi product facility B.WORLD CLASS PHARMA MANUFACTURING FACILITY DESIGN TYPES OF MANUFACTURING FACILITY A.

WORLD CLASS PHARMA MANUFACTURING FACILITY Components of Facility: - Shipping / Receiving Warehouses Manufacturing Plant Packaging Areas Quality Operations Office Block Utilities Floor .

Processing of multiple products concurrently.Unidirectional flow . . .Ensure integrity of final product .WORLD CLASS PHARMA MANUFACTURING FACILITY DESIGN ISSUES Basic Criteria.Prevention of Cross contamination .

WORLD CLASS PHARMA MANUFACTURING FACILITY Architectural Design Process Programming Phase Problem Seeking Design Phase Problem Solving Documentation Phase Construction Phase Implementation Validation .

WORLD CLASS PHARMA MANUFACTURING FACILITY SOME IMPORTANT PARAMETERS .HVAC DESIGN .TYPE OF TECHNOLOGIES .AUTOMATION .LAYOUT .WATER SYSTEM .

Energy consumption is very high about 40% load is HVAC.Maintenance cost is very high . temperature and RH .First cost is about 20% of the project cost.WORLD CLASS PHARMA MANUFACTURING FACILITY HVAC Design and Monitoring . .Classification of the areas.Need . .Skilled manpower .Validation cost is very high.Improper air management . .Hidden variables .

WORLD CLASS PHARMA MANUFACTURING FACILITY Water Management -Potable Water -Purified Water -WFI -Generation and distribution .

.WORLD CLASS PHARMA MANUFACTURING FACILITY Project Team -Plant Manager -Mechanical Engineer -Project Engineer -Logistics Engineer -Civil Engineer -Highly Skilled Consultant A smaller team is definitely a better team.

.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.

-Under / over designing of areas.WORLD CLASS PHARMA MANUFACTURING FACILITY Proper Layout Design Some common mistakes. -No provision for waste disposal -Inadequate service areas -Under / over capacity warehouses -Insufficient Holding areas .

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. .

WORLD CLASS PHARMA MANUFACTURING FACILITY Future Requirements : -Space -Machine Capacities -Utility Design -Durable Civil Work -Modular Structures -Flooring -Expansion of Product Mix .

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.

WORLD CLASS PHARMA MANUFACTURING FACILITY Operating Cost Criteria : - Selection of right Technology Right Equipments Right Utilities Right Vendors Right Time Management Commitment .

.Ready to use solutions for Pharmaceutical plant do not exist because user requirement such as product design and quantities.Thus pharmaceutical plants .WORLD CLASS PHARMA MANUFACTURING FACILITY Summation : . production process vary from case to case.

Thank You .