ideal pharmaceutical facility presented by: ihsan ullah khan khattak chief manager production...

IDEAL PHARMACEUTICAL

FACILITY

PRESENTED BY:

IHSAN ULLAH KHAN KHATTAKChief Manager Production

Highnoon Laboratories Limited17.5 K.M. Multan Road, Lahore, Pakistan.

[email protected]

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.


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.


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


Components of Facility:

- Shipping / Receiving - Warehouses- Manufacturing Plant- Packaging Areas- Quality Operations- Office Block- Utilities Floor


DESIGN ISSUESBasic Criteria,- Prevention of Cross contamination- Processing of multiple products

concurrently.- Ensure integrity of final product- Unidirectional flow


Architectural Design Process

Programming Phase Problem Seeking

Design Phase Problem Solving

Documentation Phase

Construction Phase

Implementation Validation


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


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


Water Management

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


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


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.


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


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.


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


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.


Operating Cost Criteria :- Selection of right Technology- Right Equipments- Right Utilities- Right Vendors- Right Time Management- Commitment


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

ideal pharmaceutical facility presented by: ihsan ullah khan khattak chief manager production...

Documents

compliant facility

facility rapid change

project cost

inadequate process layout

inadequate space

validation cost

better team

maintenance cost