Professional Documents
Culture Documents
Validation
Qualification of HVAC
and water systems
Part 2
WHO Technical Report Series, No. 961,
2011. Annex 5
Objectives
8.
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
8.2.5 – 8.2.11
recorded
Normal Operating Range
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:
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
2 2,3 2 = At rest (ideally used to perform OQ)
particle)
Temperature, humidity N/A 2,3 3 = Operational (ideally used to perform PQ)
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
Warehouse
Air Lock2 Weighing Tablet 1 Tablet 2 Liquids Mix Softgel Capsule
Packing
A/ Lock1
Clean Corridor
Emergency
Exit
Male Female
2 Stage Change 2 Change 2
Sterile eyedrops personnel Primary & Secondary
dispensing entry for Packed
Packing
& aceptic filling eyedrops Goods
Air Lock 3
Quarantine
Male Female
Change 1 Change 1
Equipment Wash Air Lock 4
Service Room
Air Lock
MAL1
15Pa
30Pa
Clean Corridor
Emergency
Exit
20Pa 20Pa
PAL
40Pa Male Female 10Pa
MAL 3 Change 2 Change 2 Secondary Primary
Sterile eyedrops Packing Packing
40Pa dispensing Packed
& asceptic filling Goods
Quarantine 20Pa 30Pa
10Pa 10Pa
60Pa
Change Male Female
15Pa MAL 4
50Pa Change 1 Change 1
Equipment Wash 50Pa Air Lock 4
Service Room 0Pa
0Pa
0Pa
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
7.2
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