This document discusses commissioning, qualification, and maintenance of HVAC systems. It covers: - Commissioning includes setting up, balancing, adjusting and testing the HVAC system to ensure it meets requirements, and training personnel. Records of installation, design measurements, manuals and reports are maintained. - Qualification validates the HVAC system meets design specifications. It includes design qualification, installation qualification, operational qualification, and performance qualification based on a risk analysis. Critical parameters and components are tested. - Maintenance includes inspection of documentation, operating and maintenance procedures, environmental records, and discussion of out of specification actions. Filters are changed and devices calibrated by trained personnel to ensure product quality and continued qualification.

2.  Heating, Ventilation and Air-Conditioning (HVAC)
Part 3:
Commissioning, Qualification, and maintenance
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3. Objectives
 To understand key issues in :
commissioning,
qualification and
maintenance of HVAC systems
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4. Documentation requirements to assist in commissioning,
qualification and maintenance
 Description of design, installation and functions
 Specifications, requirements
 Manuals
 Operating procedures
 Instructions for performance control, monitoring and records
 Maintenance instructions and records
 Training of personnel
― programme and records
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5. Commissioning
 Precursor to qualification
 Includes setting up, balancing, adjustment and testing of entire
HVAC system to ensure it meets requirements in URS and
capacity
 Acceptable tolerances for parameters
 Training of personnel
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6. Commissioning (2)
Records and data maintained include:
 Installation records – documented evidence of measure
capacities of the system
 Data: Design and measurement for, e.g. airflow, system
pressures
 O&M manuals, schematic drawings, protocols, reports
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7. Qualification
 Validation is an extensive exercise
 Qualification of the HVAC system is one component in the
overall approach that covers premises, systems/utilities,
equipment, processes, etc.
 See also full guidelines on "Validation" in WHO TRS No 937,
2005, Annex 4.
 Risk-based approach for HVAC qualification
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8. Qualification (2)
 Described in a Validation Master Plan (VMP)
 VMP to include the nature and extent of tests, and
protocols
 DQ, IQ, OQ, and PQ
 Risk analysis to determine critical and non-critical
parameters, components, subsystems and controls
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9. 9

10. Qualification (3)
 Direct impact components and critical parameters
should be included
 Non-critical systems and components are subjected
to Good Engineering Practices (GEP)
 Acceptance criteria and limits defined in design
stage
 Design conditions, normal operating ranges, alert
and action limits
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11. HVAC
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Design
conditions
and normal
operating
ranges set
to
achievable
limits
OOS
results
recorded
ACTION LIMIT
ALERT LIMITALERT LIMIT
ACTION LIMIT
OperatingRange- ValidatedAcceptanceCriteria
NormalOperatingRange
DesignCondition

12. Qualification – examples of aspects to consider
 DQ – Design of the system, URS
 (e.g. components, type of air treatment needed, materials
of construction)
 IQ – Verify installation
 e.g. relevant components, ducting, filters, controls,
monitors, sensors, etc.
 includes calibration where relevant
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13. 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)
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14. 14

15. 15

16. 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
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17. Qualification (6)
Conduct of the tests:
Time intervals and procedure to be defined by the manufacturer
Influenced by the type of facility and level of protection
See also ISO 14644 for methods of testing
Requalification, and change control
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18. Qualification (7)
Tests performed according to protocols and
procedures for the tests
Results recorded and presented in report (source data
kept)
Traceability, e.g. devices and standards used,
calibration records; and conditions specified
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19. HVAC
Schedule of tests to demonstrate continuing
compliance
*Test procedure as per ISO 14644
Test procedure*
and key aspects
Maximum time
interval
ObjectiveTest Parameter
Particle counter.
Readings and
positions
6 months or 12
months depending
on Class
Verifies cleanlinessParticle count test
Measure pressure
difference
12 monthsAbsence of cross-
contamination
Air pressure
difference
Measure supply and
return air, calculate
air change rate
12 monthsVerify air change
rates
Airflow volume
Velocity
measurement
12 monthsVerify unidirectional
airflow and or
containment
condition
Airflow velocity

20. HVAC
Recommended optional strategic tests
*Test procedure as per ISO 14644
Test procedure*
and key aspects
Maximum time
interval
ObjectiveTest Parameter
Filter media and filter
seal integrity
12 monthsVerify filter integrityFilter leakage
Airflow direction and
pressure differential
12 monthsVerify absence of
cross-contamination
Containment leakage
Time taken
maximum 15
minutes
12 monthsVerify clean-up timeRecovery (time)
Airflow direction,
documented
evidence
12 monthsVerify required
airflow patterns
Airflow visualization

21. Clean room monitoring program (1)
Routine monitoring program as part of quality assurance
Additional monitoring and triggers, e.g.
1. Shutdown
2. Replacement of filter elements
3. Maintenance of air-handling systems
4. Exceeding of established limits
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22. Clean room monitoring programme (2)
 Particles and Microbiological contaminants
Number of points/locations for monitoring determined, specified,
documented in procedure and or protocol
Sufficient time for exposure, and suitable sample size
Identification and marking of sampling points
Definition of transport, storage, and incubation conditions
Results to reflect the procedure/protocol followed
Define alert and action limits as a function of cleanliness zone/class
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23. air
Example of a sampling point
Clean room monitoring program (3)
Clean rooms should be monitored for microorganisms and
particles
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24. Definition of Conditions
air
as built
air air
at rest in operation
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25. Qualification – examples of aspects to consider in
qualification (OQ, PQ)
Test
Differential pressure on filters
Turbulent / mixed
airflow
Description
Uni-directional airflow
/ LAF
Room differential pressure
Airflow velocity / uniformity
Airflow volume / rate
Parallelism
Airflow pattern
2 2
N/A 2, 3
2, 3 Optional
2 2
2 N/A
2 3
1 := As built (ideally used to perform IQ)
2 = At rest (ideally used to perform OQ)
3 = Operational (ideally used to perform PQ)
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26. Test
Turbulent / mixed
airflow
Description
Uni-directional
airflow / LAF
Recovery time
Room classification (airborne particle)
Temperature, humidity
N/A 2
2 2,3
N/A 2,3
1 := As built (ideally used to perform IQ)
2 = At rest (ideally used to perform OQ)
3 = Operational (ideally used to perform PQ)
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Qualification – examples of aspects to consider in
qualification (OQ, PQ)

27. Maintenance
• Procedure, programme and records for planned,
preventative maintenance
• e.g. cleaning of filters, calibration of devices
• Appropriate training for personnel
• Change of HEPA filters by suitably trained persons
• Impact of maintenance on:
• Product quality
• Qualification
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28. Inspecting the air-handling system
 Verification of design documentation, including
 description of installation and functions
 specification of the requirements
 Operating procedures
 Maintenance instructions
 Maintenance records
 Training logs
 Environmental records
 Discussion on actions if OOS values
 On site verification (walking around the site)
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29. 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
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30. Further proceedings
This series of explanations will now be followed by:
 Group discussion, with a simple exercise
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