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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

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

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

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

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

Thank

You