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Supplementary Training Modules on Good Manufacturing Practice
Heating, Ventilation and AirConditioning (HVAC) Part 1 (a): Introduction and overview WHO Technical Report Series, No. 937, 2006. Annex 2
HVAC
|
Slide 1 of 26
May 2006
HVAC Introduction and Scope
HVAC systems can have an impact on product quality
It can provide comfortable conditions for operators
The impact on premises and prevention of contamination and cross-contamination to be considered at the design stage
Temperature, relative humidity control where appropriate
Supplement to basic GMP text 1, 2
HVAC
|
Slide 2 of 26
May 2006
HVAC The guideline further focuses on three concepts of the system: Product protection – Contamination – Cross-contamination – Environmental conditions Personnel protection – Prevent contact – Comfort conditions Environment protection
HVAC
|
Slide 3 of 26
May 2006
2
HVAC Factors contributing to quality products
Personnel Validated processes Procedures
Starting materials Equipment
Packing materials Premises Environment
HVAC
|
Slide 4 of 26
May 2006
HVAC The manufacturing environment is critical for product quality. Factors to be considered include: 2.
Light Temperature
3.
Relative humidity
4.
Air movement
5.
Microbial contamination
6.
Particulate contamination
Uncontrolled environment can lead to product degradation
1.
product contamination (including cross-contamination) loss of product and profit HVAC
|
Slide 5 of 26
May 2006
HVAC What is contamination? It is "the undesired introduction of impurities (chemical/ microbial/ foreign matter into or on to starting material or intermediate – during sampling, production, packaging or repackaging". Impurities could include products or substances other than the product manufactured, foreign products, particulate matter, microorganisms, endotoxins (degraded microorganisms), etc.
Glossary
HVAC
|
Slide 6 of 26
May 2006
HVAC What is Cross-contamination? "Contamination of a starting material, intermediate product, or finished product with another starting material or product during production". Cross-contamination can result from, e.g. 1. Poorly designed, operated or maintained air-handling systems and dust extraction systems 2. Inadequate procedures for, and movement of personnel, materials and equipment
3. Insufficiently cleaned equipment HVAC
|
Slide 7 of 26
May 2006
Glossary, 4.1.11
HVAC Cross-Contamination
HVAC
Contaminant from Environment Operators
Contamination
Contaminant from Equipment
Product from Environment Operators
Cross Contamination
Product from Equipment
|
Slide 8 of 26
May 2006
HVAC Cross-contamination can be minimized by, e.g. 1. Personnel procedures 2. Adequate premises 3. Use of closed production systems
4. Adequate, validated cleaning procedures 5. Appropriate levels of protection of product
6. Correct air pressure cascade
HVAC
|
Slide 9 of 26
May 2006
HVAC The classification should be achieved in the state as specified (1):
"As built" – Bare room, without equipment or personnel
4.1.7 - 4.1.8
HVAC
|
Slide 10 of 26
May 2006
HVAC The classification should be achieved in the state as specified (2):
"At rest" – Equipment may be operating, but no operators present
4.1.9
HVAC
|
Slide 11 of 26
May 2006
HVAC The classification should be achieved in the state as specified (3):
"In operation" – Normal production process with equipment and personnel, – Clean up time validated – normally in the order of 20 minutes 4.1.10
HVAC
|
Slide 12 of 26
May 2006
HVAC Level of protection and air cleanliness determined according to: Product to be manufactured
Process to be used Product susceptibility to degradation
4.1.16
HVAC
|
Slide 13 of 26
May 2006
HVAC Parameters influencing Levels of Protection Number of particles in the air, number of microorganisms in the air or on surfaces Number of air changes for each room Air velocity and airflow pattern
Filters (type, position) Air pressure differentials between rooms Temperature, relative humidity
HVAC
|
Slide 14 of 26
May 2006
HVAC Tools to help achieve the desired Level of Protection Air Handling System
Production Room With Defined Requirements
Supply Air
HVAC
|
Slide 15 of 26
May 2006
Outlet Air
HVAC Tools to help achieve the desired Level of Protection (2)
Air-handling system can be the main tool for reaching required parameters May not be 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
HVAC
|
Slide 16 of 26
May 2006
HVAC Tools to help achieve the desired Level of Protection (2) Cleanroom Class defined by Critical Parameters
Air Handling System HVAC
|
Slide 17 of 26
May 2006
Additional Measures
HVAC Examples of Levels of Protection Types of Clean room classes
HVAC
WHO, EC, PIC/S:
A, B, C, D
US FDA:
Critical and controlled
ISPE:
Level 1, 2 or 3
ISO:
Class 5, 6, 7 or 8
|
Slide 18 of 26
May 2006
Supplementary Training Modules on Good Manufacturing Practice Heating, Ventilation and AirConditioning (HVAC)
Part 1 (b): Introduction and overview WHO Technical Report Series, No. 937, 2006. Annex 2 HVAC
|
Slide 19 of 26
May 2006
HVAC Air Filtration Degree of filtration is important to prevent contamination Type of filters to be used dependent on the quality of ambient air, return air and air change rates Manufacturer to determine, select and prove appropriate filters for use considering level of ambient air contamination, national requirements, product specific requirements
4.2.1, 4.2.3
HVAC
|
Slide 20 of 26
May 2006
HVAC Airflow patterns Filtered air entering a production room or covering a process can be
turbulent, or unidirectional (laminar) GMP aspect economical aspect
Other technologies: barrier technology/isolator technology.
HVAC
|
Slide 21 of 26
May 2006
HVAC Airflow patterns
HVAC
|
Turbulent
Unidirectional/laminar
dilution of dirty air
displacement of dirty air
Slide 22 of 26
May 2006
HVAC Prefilter
Airflow patterns
AHU
Main filter
HVAC
|
1
2
Turbulent
Unidirectional
Slide 23 of 26
May 2006
3
Turbulent
HVAC Unidirectional airflow (UDAF): Provided where needed over product or material to prevent contamination, or to protect operator
UDAF in weighing areas The aim is to provide dust containment Airflow velocity should not affect balance Position of material, balance, operator determined and validated – no obstruction of airflow or risk 4.3.1 – 4.3.10
HVAC
|
Slide 24 of 26
May 2006
HVAC
Annex 5, 7.
HVAC
|
Slide 25 of 26
May 2006
HVAC
Annex 5, 7.
HVAC
|
Slide 26 of 26
May 2006
HVAC Pressure differential concept Concept can include high pressure differential, low airflow, and airlocks in the design
Sufficient pressure differential required to ensure containment and prevent flow reversal – but not so high as to create turbulence Consider effect of other items such as equipment and extraction systems in cubicles Operating limits and tolerances 4.5.13 – 4.5.18, 4.5.22 HVAC
|
Slide 27 of 26
May 2006
HVAC Pressure differential concept (2) Calibrated monitoring devices, set to alarm system
Monitoring and recording of results Doors open to higher pressure
Dust extraction system design – – –
HVAC
|
Interlocked with air-handling system No airflow between rooms linked to same system Room pressure imbalance 4.5.19 – 4.5.26
Slide 28 of 26
May 2006
HVAC Pressure cascade solids Protection from cross-contamination Room 1
Room 2
15 Pa
Room 3
15 Pa
Air Lock
15 Pa
Air Lock Air Lock
30 Pa
E Passage
Note : Direction of door opening relative to room pressure HVAC
|
Slide 29 of 26
May 2006
15 Pa
0 Pa
HVAC Temperature and relative humidity (RH) Controlled, monitored and recorded where relevant
Materials and product requirements, operator comfort Minimum and maximum limits
Premises design appropriate, e.g. low humidity areas, well sealed and airlocks where necessary HVAC design – also prevent moisture migration 4.6.1. – 4.6.6
HVAC
|
Slide 30 of 26
May 2006
HVAC Temperature and relative humidity (RH) (2) Remove moisture, or add moisture as necessary Dehumidification – Refrigerated dehumidifiers with cooling media – Chemical dehumidifiers
Humidifiers should not be sources of contamination – Use of pure steam or clean steam – No chemicals added to boiler system if these can have a detrimental effect on product (e.g. some corrosion inhibitors/chelating agents) 4.6.7. – 4.6.11 HVAC
|
Slide 31 of 26
May 2006
HVAC Dust Control Dust and vapour removed at source
Point of use extraction – fixed points or movable hood – plus general directional airflow in room Ensure sufficient transfer velocity to prevent dust settling in ducting Risk analysis – airflow direction, hazards, operator 5.1. – 5.7
HVAC
|
Slide 32 of 26
May 2006
HVAC Protection of the environment (Exhaust air dust) Exhaust air from equipment and some areas of production carry heavy loads of dust (e.g. FBD, coating, weighing)
Filtration needed to prevent ambient contamination Not highly potent material – EN779 F9 filter recommended
Harmful substances (e.g. hormones) – EN1822 H12 (HEPA) filter recommended – In some cases two banks of HEPA filters – Safe change filter housings ("bag-in bag-out" filters) 6.1.1 – 6.1.5 HVAC
|
Slide 33 of 26
May 2006
Supplementary Training Modules on Good Manufacturing Practice
Heating, Ventilation and AirConditioning (HVAC)
Part 2: HVAC systems and components Section 7
HVAC
|
Slide 34 of 26
May 2006
HVAC Main subsystems Exhaust air treatment
Fresh air treatment (make-up air)
+
Terminal air treatment at production room level
Production Room
Central air handling unit
HVAC
|
Slide 35 of 26
May 2006
HVAC Overview components Exhaust Air Grille Silencer
Weather louvre
Flow rate controller
Fan
Control damper
+ Humidifier
Prefilter
Cooling coil with droplet separator
Secondary Filter
Heating coil Recirculated air HVAC
|
Slide 36 of 26
May 2006
Filter
Heater Terminal filter
Production Room
HVAC Components (1) Weather louvre
To prevent insects, leaves, dirt and rain from entering Silencer To reduce noise caused by air circulation Flow rate controller Automated adjustment of volume of air (night and day, pressure control) Control damper Fixed adjustment of volume of air
HVAC
|
Slide 37 of 26
May 2006
HVAC Components (2) Heating unit
Cooling unit/ dehumidifier Humidifier Filters Ducts
HVAC
|
Slide 38 of 26
May 2006
To heat the air to the proper temperature To cool the air to the required temperature or to remove moisture from the air To bring the air to the proper humidity, if too low To eliminate particles of predetermined dimensions and/or microorganisms To transport the air
HVAC Air-handling unit
Control damper for airflow Humid room air
Adsorber wheel
AHU with fan Variable Speed Controller
Regeneration air
Humid room air Air heater
De-humidification HVAC
|
Slide 39 of 26
Dry air
May 2006
Filter Pressure Gauges
HVAC Humidifier
HVAC
|
Slide 40 of 26
Silencer
May 2006
Heating and cooling units
HVAC Filter classes
Dust filters
Standard
Coarse
Fine
Dp > 10 µ m
10 µ m > Dp > 1 µ m
G1 - G4
F5 - F9 EN 779 Standard
HVAC
Aerosol
|
Slide 41 of 26
May 2006
HEPA
ULPA Dp < 1 µ m
H 11 - 13
U 14- 17 EN 1822 Standard
HVAC HEPA or tertiary filter
Primary panel filter
Secondary filter
HVAC
|
Slide 42 of 26
May 2006
HVAC
Classification of filters according to their efficiency
HVAC
|
F9
Average Efficiency Integral Value Retention in Penetration % 85 0.15
H11
95
0.05
H12
99.5
5x10
-3
97.5
25x10
-3
H13
99.95
5x10
-4
99.75
25x10
-4
U14
99.995
5x10
-5
99.975
25x10
-5
Slide 43 of 26
May 2006
Peak Arrestance Local Value Efficiency Penetration
HVAC Positioning of filters (1)
AHU mounted final filter
Filter in terminal position HEPA Filter
+
Production Room HEPA Filter
HVAC
|
Slide 44 of 26
May 2006
Production Room
HVAC Positioning of filters (2) Prefilter
AHU
Main filter Ceiling exhausts 2
1
Low level exhausts
HVAC
|
Slide 45 of 26
May 2006
3
HVAC Positioning of filters (3)
Final filter
AHU Prefilter
1
HVAC
|
Slide 46 of 26
2
May 2006
HVAC 1
2
3 4
Swirl Type air diffusors with terminal filters
1 2 3 4 HVAC
Filter Tightening frame Register outlet Screw fixation for register |
Slide 47 of 26
May 2006
HVAC
High induction office type diffusor (avoid) HVAC
|
Slide 48 of 26
May 2006
Low induction swirl diffusor (preferred)
HVAC Regulation of room pressure – pressure differentials concept
Room pressure gauges Room pressure indication panel
HVAC
|
Slide 49 of 26
May 2006
HVAC In the next slides Consider different air types, e.g.: Supply air
Return air (recirculated air) Fresh air (make-up air) Exhaust air
And: Concepts of air delivery to production areas: Recirculation systems Full fresh-air systems HVAC
|
Slide 50 of 26
May 2006
HVAC Air types
Fresh air (make-up air)
Supply air
+
Production Room
Return air (recirculated) HVAC
|
Slide 51 of 26
May 2006
Exhaust air
HVAC Recirculation systems There should be no risk of contamination and crosscontamination when air is recirculated
Normally, HEPA filters (EN1822 H13) needed in supply air stream – Not required in single product facility with no risk of cross-contamination – Not required where no dust generation (e.g. secondary packaging)
HEPA filters placed in AHU or terminally Dust from highly toxic processes should not be recirculated 7.2.1 – 7.2.6
HVAC
|
Slide 52 of 26
May 2006
HVAC Full fresh-air systems 100% fresh air - normally where toxic products are processed, and recirculation not recommended
No contamination from fresh air – sufficient filtration needed Degree of filtration on exhaust dependent on exhaust air contaminants and environment regulations Energy-recovery wheels – Should not be source of contamination – Relative pressure between supply and exhaust air 7.3.1 – 7.3.3
HVAC
|
Slide 53 of 26
May 2006
Heating, Ventilation and AirConditioning (HVAC) Part 1 (a): Introduction and overview WHO Technical Report Series, No. 937, 2006. Annex 2
HVAC
|
Slide 1 of 26
May 2006
HVAC Introduction and Scope
HVAC systems can have an impact on product quality
It can provide comfortable conditions for operators
The impact on premises and prevention of contamination and cross-contamination to be considered at the design stage
Temperature, relative humidity control where appropriate
Supplement to basic GMP text 1, 2
HVAC
|
Slide 2 of 26
May 2006
HVAC The guideline further focuses on three concepts of the system: Product protection – Contamination – Cross-contamination – Environmental conditions Personnel protection – Prevent contact – Comfort conditions Environment protection
HVAC
|
Slide 3 of 26
May 2006
2
HVAC Factors contributing to quality products
Personnel Validated processes Procedures
Starting materials Equipment
Packing materials Premises Environment
HVAC
|
Slide 4 of 26
May 2006
HVAC The manufacturing environment is critical for product quality. Factors to be considered include: 2.
Light Temperature
3.
Relative humidity
4.
Air movement
5.
Microbial contamination
6.
Particulate contamination
Uncontrolled environment can lead to product degradation
1.
product contamination (including cross-contamination) loss of product and profit HVAC
|
Slide 5 of 26
May 2006
HVAC What is contamination? It is "the undesired introduction of impurities (chemical/ microbial/ foreign matter into or on to starting material or intermediate – during sampling, production, packaging or repackaging". Impurities could include products or substances other than the product manufactured, foreign products, particulate matter, microorganisms, endotoxins (degraded microorganisms), etc.
Glossary
HVAC
|
Slide 6 of 26
May 2006
HVAC What is Cross-contamination? "Contamination of a starting material, intermediate product, or finished product with another starting material or product during production". Cross-contamination can result from, e.g. 1. Poorly designed, operated or maintained air-handling systems and dust extraction systems 2. Inadequate procedures for, and movement of personnel, materials and equipment
3. Insufficiently cleaned equipment HVAC
|
Slide 7 of 26
May 2006
Glossary, 4.1.11
HVAC Cross-Contamination
HVAC
Contaminant from Environment Operators
Contamination
Contaminant from Equipment
Product from Environment Operators
Cross Contamination
Product from Equipment
|
Slide 8 of 26
May 2006
HVAC Cross-contamination can be minimized by, e.g. 1. Personnel procedures 2. Adequate premises 3. Use of closed production systems
4. Adequate, validated cleaning procedures 5. Appropriate levels of protection of product
6. Correct air pressure cascade
HVAC
|
Slide 9 of 26
May 2006
HVAC The classification should be achieved in the state as specified (1):
"As built" – Bare room, without equipment or personnel
4.1.7 - 4.1.8
HVAC
|
Slide 10 of 26
May 2006
HVAC The classification should be achieved in the state as specified (2):
"At rest" – Equipment may be operating, but no operators present
4.1.9
HVAC
|
Slide 11 of 26
May 2006
HVAC The classification should be achieved in the state as specified (3):
"In operation" – Normal production process with equipment and personnel, – Clean up time validated – normally in the order of 20 minutes 4.1.10
HVAC
|
Slide 12 of 26
May 2006
HVAC Level of protection and air cleanliness determined according to: Product to be manufactured
Process to be used Product susceptibility to degradation
4.1.16
HVAC
|
Slide 13 of 26
May 2006
HVAC Parameters influencing Levels of Protection Number of particles in the air, number of microorganisms in the air or on surfaces Number of air changes for each room Air velocity and airflow pattern
Filters (type, position) Air pressure differentials between rooms Temperature, relative humidity
HVAC
|
Slide 14 of 26
May 2006
HVAC Tools to help achieve the desired Level of Protection Air Handling System
Production Room With Defined Requirements
Supply Air
HVAC
|
Slide 15 of 26
May 2006
Outlet Air
HVAC Tools to help achieve the desired Level of Protection (2)
Air-handling system can be the main tool for reaching required parameters May not be 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
HVAC
|
Slide 16 of 26
May 2006
HVAC Tools to help achieve the desired Level of Protection (2) Cleanroom Class defined by Critical Parameters
Air Handling System HVAC
|
Slide 17 of 26
May 2006
Additional Measures
HVAC Examples of Levels of Protection Types of Clean room classes
HVAC
WHO, EC, PIC/S:
A, B, C, D
US FDA:
Critical and controlled
ISPE:
Level 1, 2 or 3
ISO:
Class 5, 6, 7 or 8
|
Slide 18 of 26
May 2006
Supplementary Training Modules on Good Manufacturing Practice Heating, Ventilation and AirConditioning (HVAC)
Part 1 (b): Introduction and overview WHO Technical Report Series, No. 937, 2006. Annex 2 HVAC
|
Slide 19 of 26
May 2006
HVAC Air Filtration Degree of filtration is important to prevent contamination Type of filters to be used dependent on the quality of ambient air, return air and air change rates Manufacturer to determine, select and prove appropriate filters for use considering level of ambient air contamination, national requirements, product specific requirements
4.2.1, 4.2.3
HVAC
|
Slide 20 of 26
May 2006
HVAC Airflow patterns Filtered air entering a production room or covering a process can be
turbulent, or unidirectional (laminar) GMP aspect economical aspect
Other technologies: barrier technology/isolator technology.
HVAC
|
Slide 21 of 26
May 2006
HVAC Airflow patterns
HVAC
|
Turbulent
Unidirectional/laminar
dilution of dirty air
displacement of dirty air
Slide 22 of 26
May 2006
HVAC Prefilter
Airflow patterns
AHU
Main filter
HVAC
|
1
2
Turbulent
Unidirectional
Slide 23 of 26
May 2006
3
Turbulent
HVAC Unidirectional airflow (UDAF): Provided where needed over product or material to prevent contamination, or to protect operator
UDAF in weighing areas The aim is to provide dust containment Airflow velocity should not affect balance Position of material, balance, operator determined and validated – no obstruction of airflow or risk 4.3.1 – 4.3.10
HVAC
|
Slide 24 of 26
May 2006
HVAC
Annex 5, 7.
HVAC
|
Slide 25 of 26
May 2006
HVAC
Annex 5, 7.
HVAC
|
Slide 26 of 26
May 2006
HVAC Pressure differential concept Concept can include high pressure differential, low airflow, and airlocks in the design
Sufficient pressure differential required to ensure containment and prevent flow reversal – but not so high as to create turbulence Consider effect of other items such as equipment and extraction systems in cubicles Operating limits and tolerances 4.5.13 – 4.5.18, 4.5.22 HVAC
|
Slide 27 of 26
May 2006
HVAC Pressure differential concept (2) Calibrated monitoring devices, set to alarm system
Monitoring and recording of results Doors open to higher pressure
Dust extraction system design – – –
HVAC
|
Interlocked with air-handling system No airflow between rooms linked to same system Room pressure imbalance 4.5.19 – 4.5.26
Slide 28 of 26
May 2006
HVAC Pressure cascade solids Protection from cross-contamination Room 1
Room 2
15 Pa
Room 3
15 Pa
Air Lock
15 Pa
Air Lock Air Lock
30 Pa
E Passage
Note : Direction of door opening relative to room pressure HVAC
|
Slide 29 of 26
May 2006
15 Pa
0 Pa
HVAC Temperature and relative humidity (RH) Controlled, monitored and recorded where relevant
Materials and product requirements, operator comfort Minimum and maximum limits
Premises design appropriate, e.g. low humidity areas, well sealed and airlocks where necessary HVAC design – also prevent moisture migration 4.6.1. – 4.6.6
HVAC
|
Slide 30 of 26
May 2006
HVAC Temperature and relative humidity (RH) (2) Remove moisture, or add moisture as necessary Dehumidification – Refrigerated dehumidifiers with cooling media – Chemical dehumidifiers
Humidifiers should not be sources of contamination – Use of pure steam or clean steam – No chemicals added to boiler system if these can have a detrimental effect on product (e.g. some corrosion inhibitors/chelating agents) 4.6.7. – 4.6.11 HVAC
|
Slide 31 of 26
May 2006
HVAC Dust Control Dust and vapour removed at source
Point of use extraction – fixed points or movable hood – plus general directional airflow in room Ensure sufficient transfer velocity to prevent dust settling in ducting Risk analysis – airflow direction, hazards, operator 5.1. – 5.7
HVAC
|
Slide 32 of 26
May 2006
HVAC Protection of the environment (Exhaust air dust) Exhaust air from equipment and some areas of production carry heavy loads of dust (e.g. FBD, coating, weighing)
Filtration needed to prevent ambient contamination Not highly potent material – EN779 F9 filter recommended
Harmful substances (e.g. hormones) – EN1822 H12 (HEPA) filter recommended – In some cases two banks of HEPA filters – Safe change filter housings ("bag-in bag-out" filters) 6.1.1 – 6.1.5 HVAC
|
Slide 33 of 26
May 2006
Supplementary Training Modules on Good Manufacturing Practice
Heating, Ventilation and AirConditioning (HVAC)
Part 2: HVAC systems and components Section 7
HVAC
|
Slide 34 of 26
May 2006
HVAC Main subsystems Exhaust air treatment
Fresh air treatment (make-up air)
+
Terminal air treatment at production room level
Production Room
Central air handling unit
HVAC
|
Slide 35 of 26
May 2006
HVAC Overview components Exhaust Air Grille Silencer
Weather louvre
Flow rate controller
Fan
Control damper
+ Humidifier
Prefilter
Cooling coil with droplet separator
Secondary Filter
Heating coil Recirculated air HVAC
|
Slide 36 of 26
May 2006
Filter
Heater Terminal filter
Production Room
HVAC Components (1) Weather louvre
To prevent insects, leaves, dirt and rain from entering Silencer To reduce noise caused by air circulation Flow rate controller Automated adjustment of volume of air (night and day, pressure control) Control damper Fixed adjustment of volume of air
HVAC
|
Slide 37 of 26
May 2006
HVAC Components (2) Heating unit
Cooling unit/ dehumidifier Humidifier Filters Ducts
HVAC
|
Slide 38 of 26
May 2006
To heat the air to the proper temperature To cool the air to the required temperature or to remove moisture from the air To bring the air to the proper humidity, if too low To eliminate particles of predetermined dimensions and/or microorganisms To transport the air
HVAC Air-handling unit
Control damper for airflow Humid room air
Adsorber wheel
AHU with fan Variable Speed Controller
Regeneration air
Humid room air Air heater
De-humidification HVAC
|
Slide 39 of 26
Dry air
May 2006
Filter Pressure Gauges
HVAC Humidifier
HVAC
|
Slide 40 of 26
Silencer
May 2006
Heating and cooling units
HVAC Filter classes
Dust filters
Standard
Coarse
Fine
Dp > 10 µ m
10 µ m > Dp > 1 µ m
G1 - G4
F5 - F9 EN 779 Standard
HVAC
Aerosol
|
Slide 41 of 26
May 2006
HEPA
ULPA Dp < 1 µ m
H 11 - 13
U 14- 17 EN 1822 Standard
HVAC HEPA or tertiary filter
Primary panel filter
Secondary filter
HVAC
|
Slide 42 of 26
May 2006
HVAC
Classification of filters according to their efficiency
HVAC
|
F9
Average Efficiency Integral Value Retention in Penetration % 85 0.15
H11
95
0.05
H12
99.5
5x10
-3
97.5
25x10
-3
H13
99.95
5x10
-4
99.75
25x10
-4
U14
99.995
5x10
-5
99.975
25x10
-5
Slide 43 of 26
May 2006
Peak Arrestance Local Value Efficiency Penetration
HVAC Positioning of filters (1)
AHU mounted final filter
Filter in terminal position HEPA Filter
+
Production Room HEPA Filter
HVAC
|
Slide 44 of 26
May 2006
Production Room
HVAC Positioning of filters (2) Prefilter
AHU
Main filter Ceiling exhausts 2
1
Low level exhausts
HVAC
|
Slide 45 of 26
May 2006
3
HVAC Positioning of filters (3)
Final filter
AHU Prefilter
1
HVAC
|
Slide 46 of 26
2
May 2006
HVAC 1
2
3 4
Swirl Type air diffusors with terminal filters
1 2 3 4 HVAC
Filter Tightening frame Register outlet Screw fixation for register |
Slide 47 of 26
May 2006
HVAC
High induction office type diffusor (avoid) HVAC
|
Slide 48 of 26
May 2006
Low induction swirl diffusor (preferred)
HVAC Regulation of room pressure – pressure differentials concept
Room pressure gauges Room pressure indication panel
HVAC
|
Slide 49 of 26
May 2006
HVAC In the next slides Consider different air types, e.g.: Supply air
Return air (recirculated air) Fresh air (make-up air) Exhaust air
And: Concepts of air delivery to production areas: Recirculation systems Full fresh-air systems HVAC
|
Slide 50 of 26
May 2006
HVAC Air types
Fresh air (make-up air)
Supply air
+
Production Room
Return air (recirculated) HVAC
|
Slide 51 of 26
May 2006
Exhaust air
HVAC Recirculation systems There should be no risk of contamination and crosscontamination when air is recirculated
Normally, HEPA filters (EN1822 H13) needed in supply air stream – Not required in single product facility with no risk of cross-contamination – Not required where no dust generation (e.g. secondary packaging)
HEPA filters placed in AHU or terminally Dust from highly toxic processes should not be recirculated 7.2.1 – 7.2.6
HVAC
|
Slide 52 of 26
May 2006
HVAC Full fresh-air systems 100% fresh air - normally where toxic products are processed, and recirculation not recommended
No contamination from fresh air – sufficient filtration needed Degree of filtration on exhaust dependent on exhaust air contaminants and environment regulations Energy-recovery wheels – Should not be source of contamination – Relative pressure between supply and exhaust air 7.3.1 – 7.3.3
HVAC
|
Slide 53 of 26
May 2006
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