M06 AirHandling01 F - U

Air Handling Systems
Heating Ventilation and Air Conditioning (HVAC) Part 1

Pharmaceutical Quality, Good manufacturing Practice & Bioequivalence
Kiev, Ukraine
3 - 7 October 2005
M.Sci.Pharm Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster Tel: +41.22.791.3598 Fax: +41.22.791.4730 World Health Organization
Maija Hietava
E-mail: hietavam@who.int
WHO - PSM

Objectives
To understand:
1.
The need and reason for pharmaceutical
air handling systems

1. 2.
The technical requirements for air handling systems Different types of air handling systems
3.
Qualification and monitoring requirements
WHO - PSM

Factors that contribute to quality products:
1.
2. 3. 4. 5. 6. 7.
Starting materials and packaging materials

Validated processes Personnel Procedures Equipment Design and quality of premises Manufacturing environment
Inadequacies in the above factors will lead to sub-standard products.
WHO - PSM

Factors contributing to quality products
Validated processes Procedures Personnel
Starting materials Equipment
Packing materials Premises Environment
WHO - PSM

The manufacturing environment is critical for product quality
1.
Light
Temperature Humidity Air movement Microbial contamination Particulate contamination Uncontrolled environment can lead to product degradation
product contamination loss of product and profit
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2. 3. 4. 5. 6. 7.

What are contaminants ?
Contaminants are
1. 2. 3. 4. 5.
Products or substances other than product manufactured Foreign products Particulate matter Micro-organisms Endotoxins (degraded micro-organisms)
Cross-contamination is a particular case of contamination

WHO - PSM

Cross-Contamination (1)
What is Cross-Contamination ? Definition of Cross-Contamination: Contamination of a starting material, intermediate product, or finished product with another starting material or product during production.
(WHO)
Part 1, Glossary
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From where does Cross-Contamination originate?
1. 2. 3. 4.
Poorly designed air handling systems and dust extraction systems Poorly operated and maintained air handling systems and dust extraction systems Inadequate procedures for personnel and equipment Insufficiently cleaned equipment
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Cross-Contamination ( 3 )
Contaminant from Environment Operators
Contamination
Contaminant from Equipment
Product from Environment Operators
Cross Contamination
Product from Equipment
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Cross-contamination can be minimized by:
1. 2.
Personnel procedures Adequate premises
3.
4. 5.
Use of closed production systems

Adequate, validated cleaning procedures Appropriate levels of protection of product
6.
Correct air pressure cascade
WHO - PSM

Level of Protection Concept
1. 2. 3. 4.
Defines environmental requirements Helps prevent contamination and cross-contamination Allows production under optimal hygiene conditions Takes into account
product sensitivity to contamination
therapeutic risk
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Cleanroom Class A / B Cleanroom Class C Cleanrm. Class D Therapeutic risks Others
Manufacturing Environment requirements
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Levels of Protection
Parameters to be defined:
1.
Air cleanliness requirements (filters type and position, air changes, air flow patterns, pressure differentials, contamination levels by particulate matter and microorganisms) Personnel and material transfer methods Permitted operations Building design and finishes
Part 3, 9.2, 9.9-9.12
2. 3. 4.
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Types of Cleanroom Classes
International
WHO
A, B, C, D A, B, C, D critical and controlled level 1, 2 or 3 or cleanroom class
National
Companies :
EC, PIC/S, TGA, etc. : US FDA : ISPE:
various others
WHO - PSM
Part 3, 4.1

Levels of Protection All operations within a pharmaceutical facilility must be correlated to well-defined cleanroom classes, and can be included in a hygiene concept. Example:
Cleanroom Class Washing of containers Preparation of solution for terminal sterilisation Preparation of solutions for aseptic filling Depyrogenisation of containers Filling for terminal sterilisation Filling for aseptic process etc. X X X X X X X A B C D X
Part 3, 4.1
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Based on the cleanroom class requirements, various Levels of Protection have to be created, including:
Correlation between process operations and cleanroom classes Type of operation permitted in each Level of Protection Definition of cleanroom class (parameters, building materials, room requirements, HVAC systems) Requirements for personnel and material in the different classes (clothing, training, type of materials, etc.) Requirements on entry conditions for personnel and material ( change procedures )
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Parameters influencing Levels of Protection (1)
Air Handling System
Supply Air
Production Room With Defined Requirements
Outlet Air
Part 3, 4.1
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1 2 3 4 5 6 7
Number of particles in the air

Number of micro-organisms in the air or on surfaces Number of air changes for each room Air velocity Air flow pattern Filters ( type, position ) Air pressure differentials between rooms
Temperature, humidity
WHO - PSM

Cleanroom Class defined by Critical Parameters
Air Handling System
Additional Measures
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Air handling systems:

Are the main tool for reaching required parameters
But are not sufficient as such

Need for additional measures such as
appropriate gowning (type of clothing, proper changing rooms) validated sanitation adequate transfer procedures for materials and personnel
WHO - PSM

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Air Handling Systems

Heating Ventilation and Air Conditioning (HVAC) Part 1

Air Handling Systems

The need and reason for pharmaceutical

air handling systems

Qualification and monitoring requirements

Air Handling Systems

Starting materials and packaging materials

Inadequacies in the above factors will lead to sub-standard products.

Air Handling Systems

Starting materials Equipment

Packing materials Premises Environment

Air Handling Systems

Air Handling Systems

Cross-contamination is a particular case of contamination

Air Handling Systems

Air Handling Systems

Air Handling Systems

Contaminant from Equipment

Product from Environment Operators

Product from Equipment

Air Handling Systems

Personnel procedures Adequate premises

Use of closed production systems

Correct air pressure cascade

Air Handling Systems

Air Handling Systems

Cleanroom Class A / B Cleanroom Class C Cleanrm. Class D Therapeutic risks Others

Manufacturing Environment requirements

Air Handling Systems

Air Handling Systems

A, B, C, D A, B, C, D critical and controlled level 1, 2 or 3 or cleanroom class

EC, PIC/S, TGA, etc. : US FDA : ISPE:

Air Handling Systems

Air Handling Systems

Air Handling Systems

Production Room With Defined Requirements

Air Handling Systems

Number of particles in the air

Air Handling Systems

Cleanroom Class defined by Critical Parameters

Air Handling System

Air Handling Systems

Are the main tool for reaching required parameters

But are not sufficient as such

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