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Validation-Part 2
Validation-Part 2
Validation
Qualification of HVAC
and water systems
Part 2
WHO Technical Report Series, No. 937,
2006. Annex 4. Appendix 1 and 2
Objectives
Commissioning
Precursor to qualification
Training of personnel
Commissioning (2)
Records and data maintained include:
Qualification
Validation is an extensive exercise
Qualification (2)
8.2.2 – 8.2.5
Qualification (3)
Direct impact components and critical parameters should be
included
Qualification (4)
Typical parameters to be included in qualification (based on risk
assessment):
Temperature
Relative humidity
Supply, return and exhaust air quantities
Room air change rates
Room pressures (pressure differentials)
8.2.17
Qualification (5)
Typical parameters to be included in qualification (based on risk
assessment) (2):
Room clean-up rate
Particulate matter, microbial matter (viable and non-viable)
HEPA filter penetration tests
Containment system velocity
Warning/alarm systems
8.2.17
Qualification (6)
Conduct of the tests:
Time intervals and procedure to be defined by the manufacturer
Qualification (7)
Definition of Conditions
Parallelism 2 N/A
Airflow pattern 2 3
Uni-directional Turbulent /
Test Description
airflow / LAF mixed airflow
Recovery time N/A 2 1 := As built (ideally used to perform IQ)
Room classification (airborne particle) 2 2,3 2 = At rest (ideally used to perform OQ)
Maintenance
Procedure, programme and records for planned, preventative
maintenance
– e.g. Cleaning of filters, calibration of devices
Conclusion
Air-handling systems:
Play a major role in the quality of pharmaceuticals
Should be designed properly, by professionals
Should be treated as a critical system
Further proceedings
W a re h o u se
A ir L o c k 2 W e ig h in g T a b le t 1 T a b le t 2 L iq u id s M ix S o ftg e l C a p su le
P a c kin g
A / Lock 1
C le a n C o rrid o r
E m ergenc y
E x it
M a le F e m a le
2 S ta g e Change 2 Change 2
S te ril e e y e d ro p s p e rso n n e l P rim a ry & S e c o n d a ry
d isp e n sin g e n try fo r P a c ke d
P a c kin g
& a c e p tic fillin g e y e d ro p s G oods
A ir L o c k 3
Q u a ra n ti n e
M a le F e m a le
Change 1 Change 1
E q u ip m e n t W a sh A ir L o c k 4
S e rv i c e R o o m
15P a
30P a
C l e a n C o rri d o r
E m ergenc y
E x it
20P a 20P a
PAL
40P a M a le F e m a le 10P a
M AL 3 Change 2 Change 2 S e c o n d a ry P rim a ry
S te rile e y e d ro p s P a c kin g
40P a
P a c kin g
d isp e n sin g P a c ke d
& a sc e p tic fillin g G oods
Q u a ra n tin e 20P a 30P a
10P a 10P a
60P a
Change M a le F e m a le
15P a M AL 4
50P a Change 1 Change 1
E q u ip m e n t W a sh 50P a A ir L o c k 4
S e rv i c e R o o m 0P a
0P a
0P a
MAL = Material Air Lock
PAL = Personnel Air Lock
Validation | Slide 30 of 48 August 2006
Supplementary Training Modules on
Good Manufacturing Practice
Commissioning,
Qualification and
validation of Water
systems
Objectives
Objectives
To discuss the operational considerations of water systems
including:
Monitoring
Maintenance
System reviews
7.
Qualification
WPU systems are "direct impact systems"
7.2
Qualification
Presentation focusing on PQ
Phase 1 (1)
A test period of 2–4 weeks - monitoring the system intensively
7.2
Phase 1 (2)
Sample daily:
– incoming feed-water
– after each step in the purification process
– each point of use and at other defined sample points
Develop:
– appropriate operating ranges
– and finalize operating, cleaning, sanitizing and maintenance
procedures
7.2
Phase 1 (3)
Demonstrate production and delivery of product water of the
required quality and quantity
7.2
Phase 2 (1)
A further test period of 2–4 weeks – further intensive monitoring
the system
7.2
Phase 2 (2)
Demonstrate:
Consistent operation within established ranges
7.2
Phase 3
Over one year after the satisfactory completion of phase 2
Demonstrate:
– extended reliable performance
– that seasonal variations are evaluated
7.3
Samples taken:
– From points of use, and specific sample points
– In a similar way how water is used in service
7.3
Maintenance
Calibration programme
System review
7.5
Group session