HVAC | Slide 1 of 26 May 2006 Heating, Ventilation and Air- Conditioning (HVAC) Part 1 (a):...
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Transcript of HVAC | Slide 1 of 26 May 2006 Heating, Ventilation and Air- Conditioning (HVAC) Part 1 (a):...
HVAC | Slide 1 of 26 May 2006
Heating, Ventilation and Air- Conditioning (HVAC)
Part 1 (a):
Introduction and overview
Supplementary Training Modules on Good Manufacturing Practice
WHO Technical Report Series, No. 937, 2006. Annex 2
HVAC | Slide 2 of 26 May 2006
HVACHVAC
Objectives
To understand:
The need for HVAC systems (Part 1a)
The role of HVAC in protection:– Product– Personnel– Environment
The role of HVAC in dust control (Part 1b)
HVAC system design and its components (Part 2)
Commissioning, qualification and maintenance (Part 3)
1, 2
HVAC | Slide 3 of 26 May 2006
HVACHVAC
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 text1, 2
HVAC | Slide 4 of 26 May 2006
Factors contributing to quality products
Starting materials
Personnel
Procedures
Validated processes
Equipment
Premises
Environment
Packing materials
HVAC
HVAC | Slide 5 of 26 May 2006
The manufacturing environment is critical for product quality. Factors to be considered include:
1. Light
2. Temperature
3. Relative humidity
4. Air movement
5. Microbial contamination
6. Particulate contamination
Uncontrolled environment can lead to product degradation
product contamination (including cross-contamination)
loss of product and profit
HVAC
HVAC | Slide 6 of 26 May 2006
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, micro-organisms, endotoxins (degraded microorganisms), etc.
HVAC
Glossary
HVAC | Slide 7 of 26 May 2006
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
Glossary, 4.1.11
HVAC | Slide 8 of 26 May 2006
Contamination
Contaminant from
EnvironmentOperators
Contaminant from
Equipment
CrossContamination
Productfrom
EnvironmentOperators
Productfrom
Equipment
Cross-Contamination
HVAC
HVAC | Slide 9 of 26 May 2006
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
HVAC | Slide 10 of 26 May 2006
HVACHVAC
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 2
HVAC | Slide 11 of 26 May 2006
HVACHVAC
Protection: Product and personnel
Areas where materials and products are exposed, should be classified as "clean areas"
Achievement of clean area classification depends on factors such as:
– Building finishes and structure– Air filtration– Air change rate– Room pressure– Temperature– Relative humidity– Material and personnel flow– Outside environment– Occupancy and type of product
4.1.1 - 4.1.3
HVAC | Slide 12 of 26 May 2006
HVACHVAC
Air filtration and air change rate should ensure attainment of classification
Air change rate is dependent on factors, e.g.– Level of protection required– Quality and filtration of supply air– Particulates generated– Room configuration– Containment effect– Room heat load– Room pressure
Air change rate normally varies between 6 – 20 air changes per hour
4.1.4 - 4.1.6
HVAC | Slide 13 of 26 May 2006
HVACHVAC
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 14 of 26 May 2006
HVACHVAC
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 15 of 26 May 2006
HVACHVAC
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 16 of 26 May 2006
HVACHVAC
Control of contaminants
External contaminants removed through effective filtration
Internal contaminants controlled through dilution and flushing, or displacement airflow
Airborne particulates and level of filtration considered critical
4.1.12 - 4.1.15
HVAC | Slide 17 of 26 May 2006
Therapeutic risks
Man
ufactu
ring
En
viron
men
t req
uirem
ents
Clean
roo
m C
lass A / B
Clean
roo
m C
lass C
Clean
rm. C
lass D
Oth
ers
HVAC
HVAC | Slide 18 of 26 May 2006
HVACHVAC
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 19 of 26 May 2006
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
HVAC | Slide 20 of 26 May 2006
Tools to help achieve the desired Level of Protection
Air Handling System
Production RoomWith
DefinedRequirements
SupplyAir
OutletAir
HVAC
HVAC | Slide 21 of 26 May 2006
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
HVAC | Slide 22 of 26 May 2006
Cleanroom Classdefined by
Critical Parameters
Air HandlingSystem
Additional Measures
Tools to help achieve the desired Level of Protection (2)
HVAC
HVAC | Slide 23 of 26 May 2006
Examples of Levels of Protection
Types of Clean room classes
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
HVAC
HVAC | Slide 24 of 26 May 2006
Particles / m3
0.5µm
US 209Dnon-
metric
US 209E1992
metric
EC cGMPAnnex I
1997
GermanyVDI 2083
1990
UKBS 5295
1989
JapanJIS B 9920
1989
ISO 14644-1
1
3,5 0 2 2
10 M 1
35 1 M 1.5 1 3 3
100 M 2
353 10 M 2.5 2 4 4
1.000 M 3
3.530 100 M 3.5 A, BA= unidirectional
B= turbulent
3 E or F 5 5
10.000 M 4
35.300 1.000 M 4.5 4 G or H 6 6
100.000 M 5
353.000 10.000 M 5.5 C 5 J 7 7
1.000.000 M 6
3.530.000 100.000 M 6.5 D 6 K 8 8
10.000.000 M 7
Comparing International Cleanroom Classifications
HVAC
HVAC | Slide 25 of 26 May 2006
HVACHVAC
Examples of levels of protection4.1.16
LevelConditionExample of area
Level 1GeneralArea with normal housekeeping, e.g. warehouse
Level 2ProtectedArea where steps are taken to protect exposed material/product, e.g. dispensing
Level 3ControlledArea with defined, controlled, monitored environmental conditions to prevent contamination and degradation
HVAC | Slide 26 of 26 May 2006
All operations within a pharmaceutical facilility should be correlated to well-defined clean room classes, and can be included in a hygiene concept.
Example:
etc.
XFilling for aseptic process
XFilling for terminal sterilisation
XDepyrogenisation of containers
XXXPreparation of solutions for aseptic filling
XPreparation of solution for terminal sterilisation
XWashing of containers
DCBACleanroom Class
HVAC