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

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WHAT IS THE NEED?

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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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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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PRESENT SCENARIO:
Many existing facilities have ; Inadequate process layout. Inadequate space. Inadequate hygiene & sanitary conditions. Inadequate HVAC system Inadequate utilities layout

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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Components of Facility:
Shipping / Receiving Warehouses Manufacturing Plant Packaging Areas Quality Operations Office Block Utilities Floor

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DESIGN ISSUES
Basic Criteria,
- Prevention of Cross contamination - Processing of multiple products concurrently. - Ensure integrity of final product - Unidirectional flow

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Architectural Design Process

Programming Phase

Problem Seeking

Design Phase

Problem Solving

Documentation Phase Construction Phase

Implementation Validation

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SOME IMPORTANT PARAMETERS - LAYOUT - HVAC DESIGN - WATER SYSTEM - AUTOMATION - TYPE OF TECHNOLOGIES

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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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Water Management
-Potable Water -Purified Water -WFI -Generation and distribution

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

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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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Proper Layout Design

Some 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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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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Future Requirements :
-Space -Machine Capacities -Utility Design -Durable Civil Work -Modular Structures -Flooring -Expansion of Product Mix

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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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Operating Cost Criteria :

Selection of right Technology Right Equipments Right Utilities Right Vendors Right Time Management Commitment

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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.

Thank You