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Part 1 (a):
Introduction and overview
WHO Technical Report Series,
No. 937, 2006. Annex 2
Personnel protection
– Prevent contact
– Comfort conditions
Environment protection 2
Personnel
Factors contributing to
Validated processes
quality products
Procedures
Starting materials
Equipment
Packing materials
Premises
Environment
Glossary
Cross-Contamination
Contaminant
Contaminant
from
Contamination from
Environment
Equipment
Operators
Product
Product
from Cross
from
Environment Contamination
Equipment
Operators
2. Adequate premises
"As built"
– Bare room, without equipment or
personnel
4.1.7 - 4.1.8
"At rest"
– Equipment may be operating, but
no operators present
4.1.9
"In operation"
– Normal production process with
equipment and personnel,
Process to be used
4.1.16
Air Handling
System
Production Room
Supply With Outlet
Air Defined Air
Requirements
Cleanroom Class
defined by
Critical Parameters
ISPE: Level 1, 2 or 3
ISO: Class 5, 6, 7 or 8
Part 1 (b):
Introduction and overview
WHO Technical Report Series,
No. 937, 2006. Annex 2
4.2.1, 4.2.3
Airflow patterns
Filtered air entering a production room or covering a
process can be
turbulent, or
unidirectional (laminar)
GMP aspect
economical aspect
Airflow patterns
Turbulent Unidirectional/laminar
dilution of dirty air displacement of dirty air
AHU
Main filter
1 2 3
Annex 5, 7.
Annex 5, 7.
15 Pa 15 Pa 15 Pa
Air
Lock
30 Pa E 0 Pa
Passage
15 Pa
5.1. – 5.7
Part 2:
HVAC systems and components
Section 7
Production Room
Central air handling unit
Heater
+
Humidifier
Prefilter Terminal filter
Components (1)
Components (2)
Heating unit To heat the air to the proper
temperature
Cooling unit/ To cool the air to the required
dehumidifier temperature or to remove moisture
from the air
Humidifier To bring the air to the proper humidity,
if too low
Filters To eliminate particles of predetermined
dimensions and/or microorganisms
Ducts To transport the air
Air-handling unit
Standard Aerosol
G1 - G4 F5 - F9 H 11 - 13 U 14- 17
Secondary filter
H11 95 0.05
-3 -3
H12 99.5 5x10 97.5 25x10
-4 -4
H13 99.95 5x10 99.75 25x10
-5 -5
U14 99.995 5x10 99.975 25x10
HEPA Filter
AHU
Main filter
Ceiling
exhausts
1 2 3
AHU
Prefilter
1 2
3
4
Room pressure
gauges
Air types
+ Exhaust
Fresh air Supply air
(make-up air) air
Production Room
Return air
(recirculated)
Energy-recovery wheels
– Should not be source of contamination
– Relative pressure between supply and exhaust air
7.3.1 – 7.3.3