Part I: Introduction and overview
Air Handling
SystemsSupplementary Training Modules on GMP
Module3: Part 1: Introduction and overview Slide of 20
WHO - EDM
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H eating V entilation and A ir C onditioning (HVAC) Part I: Introduction and
Содержание
- 1. H eating V entilation and A ir C onditioning (HVAC) Part I: Introduction and
- 2. Objectives To understand: The need and reason
- 3. Factors that contribute to quality products: Starting
- 4. Factors contributing to quality products
- 5. The manufacturing environment is critical for product
- 6. What are contaminants ?Contaminants are Products or
- 7. Cross-Contamination (1)What is Cross-Contamination ?Definition of Cross-Contamination:
- 8. Cross-Contamination (2)From where does Cross-Contamination originate?Poorly designed
- 9. Cross-Contamination ( 3 )
- 10. Cross-Contamination (4)Cross-contamination can be minimized by:Personnel proceduresAdequate
- 11. Level of Protection Concept Defines environmental requirements
- 12. Therapeutic risksManufacturing Environment requirementsCleanroom Class A / BCleanroom Class CCleanrm. Class D Others
- 13. Levels of ProtectionParameters to be defined:Air cleanliness
- 14. Levels of ProtectionTypes of Cleanroom Classes
- 15. Levels of Protection All operations within a
- 16. Levels of ProtectionBased on the cleanroom class
- 17. Parameters influencing Levels of Protection (1) Annex 1, 17.4
- 18. Parameters influencing Levels of Protection (2)Number of
- 19. Cleanroom Classdefined byCritical ParametersAir HandlingSystemAdditional MeasuresParameters influencing Levels of Protection (3)
- 20. Parameters influencing Levels of Protection (4)Air handling
- 21. Скачать презентанцию
Objectives To understand: The need and reason for pharmaceutical air handling systemsThe technical requirements for air handling systemsDifferent types of air handling systemsQualification and monitoring requirements
Слайды и текст этой презентации
Слайд 1
Heating
Ventilation and
Air Conditioning (HVAC)
Part I: Introduction and overview
Systems
Слайд 2Objectives
To understand:
The need and reason for pharmaceutical
air handling systems
The technical requirements for air handling systems
Different types
of air handling systemsQualification and monitoring requirements
Слайд 3Factors that contribute to quality products:
Starting materials and packaging
materials
Validated processes
Personnel
Procedures
Equipment
Design and quality of
premisesManufacturing environment
Inadequacies in the above factors will lead to sub-standard products.
Слайд 5The manufacturing environment is critical for
product quality
Light
Temperature
Humidity
Air
movementMicrobial contamination
Particulate contamination
Uncontrolled environment can lead to product degradation
product contamination
loss of product and profit
Слайд 6What are contaminants ?
Contaminants are
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
Слайд 7Cross-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)Annex 1, Glossary
Слайд 8Cross-Contamination (2)
From where does Cross-Contamination originate?
Poorly designed air handling systems
and dust extraction systems
Poorly operated and maintained air handling systems
and dust extraction systemsInadequate procedures for personnel and equipment
Insufficiently cleaned equipment
Слайд 10Cross-Contamination (4)
Cross-contamination can be minimized by:
Personnel procedures
Adequate premises
Use of closed
production systems
Adequate, validated cleaning procedures
Appropriate levels of protection of product
Correct
air pressure cascade
Слайд 11Level of Protection Concept
Defines environmental requirements
Helps prevent
contamination and cross-contamination
Allows production under optimal hygiene conditions
Takes
into account product sensitivity to contamination
therapeutic risk
Слайд 12Therapeutic risks
Manufacturing Environment requirements
Cleanroom Class A / B
Cleanroom Class C
Cleanrm.
Class D
Others
Слайд 13Levels of Protection
Parameters to be defined:
Air cleanliness requirements (filters type
and position, air changes, air flow patterns, pressure differentials, contamination
levels by particulate matter and micro-organisms)Personnel and material transfer methods
Permitted operations
Building design and finishes
Annex 1, 17.3, 17.4
Слайд 14Levels of Protection
Types of Cleanroom Classes
International
WHO A,
B, C, D
National
EC, PIC/S, TGA, etc.
: A, B, C, D US FDA : critical and controlled
ISPE: level 1, 2 or 3 or cleanroom class
Companies : various others
Annex 1, 17.3, 17.4
Слайд 15Levels 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:
Annex 1, 17.3, 17.4, 17.5
Cleanroom Class
Слайд 16Levels of Protection
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 )
Слайд 18Parameters influencing Levels of Protection (2)
Number of particles in the
air
Number of micro-organisms in the air or on surfaces
Number of
air changes for each roomAir velocity
Air flow pattern
Filters ( type, position )
Air pressure differentials between rooms
Temperature, humidity
Слайд 19Cleanroom Class
defined by
Critical Parameters
Air Handling
System
Additional Measures
Parameters influencing Levels of Protection
Слайд 20Parameters influencing Levels of Protection (4)
Air handling systems:
Are
the main tool for reaching required parameters
But are
not sufficient as suchNeed for additional measures such as
appropriate gowning (type of clothing, proper changing rooms)
validated sanitation
adequate transfer procedures for materials and personnel
Annex 1, 17.10 to 17.16
