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
regulatory standards.
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.
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
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
WORLD CLASS PHARMA MANUFACTURING
FACILITY
Components of Facility:
-
Shipping / Receiving
Warehouses
Manufacturing Plant
Packaging Areas
Quality Operations
Office Block
Utilities Floor
WORLD CLASS PHARMA MANUFACTURING
FACILITY
DESIGN ISSUES
Basic Criteria,
- Prevention of Cross contamination
- Processing of multiple products
concurrently.
- Ensure integrity of final product
- Unidirectional flow
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
- LAYOUT
- HVAC DESIGN
- WATER SYSTEM
- AUTOMATION
- TYPE OF TECHNOLOGIES
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
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.
WORLD CLASS PHARMA MANUFACTURING
FACILITY
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
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
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.
Thank You