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HVAC
Slide 1 of 28
May 2006
HVAC
Objectives
To understand key issues in
commissioning,
qualification and
maintenance of HVAC systems
8.
HVAC
Slide 2 of 28
May 2006
HVAC
Documentation requirements to assist in
commissioning, qualification and maintenance
HVAC
May 2006
HVAC
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
HVAC
Slide 4 of 28
May 2006
HVAC
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
8.1.2, 8.1.3,
8.1.6
HVAC
Slide 5 of 28
May 2006
HVAC
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
8.2.1
HVAC
Slide 6 of 28
May 2006
HVAC
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
8.2.2 - 8.2.5
HVAC
Slide 7 of 28
May 2006
HVAC
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, operating
ranges, alert and action limits
8.2.5 - 8.2.11
HVAC
Slide 8 of 28
May 2006
HVAC
Design
conditions
and normal
operating
ranges set to
achievable
limits
A C TIO N LIM IT
A C TIO N L IM IT
A L E R T L IM IT
A L E R T LIM IT
D e s ig n C o n d itio n
OOS results
recorded
N o r m a l O p e r a tin g R a n g e
8.2.12 8.2.15
HVAC
Slide 9 of 28
May 2006
HVAC
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
HVAC
Slide 10 of 28
May 2006
HVAC
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
HVAC
Slide 11 of 28
May 2006
HVAC
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.
HVAC
Slide 12 of 28
May 2006
HVAC
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
8.2.18 8.2.20, 8.2.9
HVAC
Slide 13 of 28
May 2006
HVAC
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
HVAC
Slide 14 of 28
May 2006
HVAC
Schedule of tests to demonstrate continuing compliance
Test Parameter
Objective
Maximum time
interval
Test procedure*
and key aspects
Verifies cleanliness
6 months or 12
months depending on
Class
Particle counter.
Readings and
positions
Air pressure
difference
Absence of crosscontamination
12 months
Measure pressure
difference
Airflow volume
12 months
Airflow velocity
Verify unidirectional
12 months
airflow and or
containment condition
Slide 15 of 28
May 2006
Velocity measurement
8. Table 3
HVAC
Recommended optional strategic tests
Test Parameter
Objective
Maximum time
interval
Test procedure*
and key aspects
Filter leakage
12 months
Containment leakage
Verify absence of
cross-contamination
12 months
Recovery (time)
12 months
Airflow visualization
12 months
Airflow direction,
documented evidence
Slide 16 of 28
May 2006
8. Table 3
HVAC
Cleanroom 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
HVAC
Slide 17 of 28
May 2006
HVAC
Cleanroom 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
Slide 18 of 28
May 2006
HVAC
Cleanroom monitoring program (3)
Cleanrooms should be monitored for microorganisms and
particles
air
Slide 19 of 28
May 2006
HVAC
Definition of Conditions
HVAC
as built
at rest
in operation
air
air
air
Slide 20 of 28
May 2006
HVAC
Qualification examples of aspects to consider in
qualification (OQ, PQ)
Uni-directional
airflow / LAF
Test
Turbulent / mixed
airflow
N/A
2, 3
2, 3
Optional
Description
Parallelism
N/A
Airflow pattern
HVAC
Slide 21 of 28
May 2006
HVAC
Qualification examples of aspects to consider in
qualification (OQ, PQ)
Uni-directional
airflow / LAF
Test
Turbulent / mixed
airflow
Description
Recovery time
N/A
2,3
Temperature, humidity
N/A
2,3
HVAC
Slide 22 of 28
May 2006
HVAC
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
HVAC
Slide 23 of 28
May 2006
8.3.1 8.3.5
HVAC
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)
HVAC
Slide 24 of 28
May 2006
HVAC
Conclusion
Air-handling systems:
HVAC
Slide 25 of 28
May 2006
HVAC
Further proceedings
This series of explanations will now be followed by:
HVAC
Slide 26 of 28
May 2006
HVAC
Group Session
S a m p lin g
Rooom
S e rv ic e C o rrid o r
( c o n t a in s V a c u u m & R O w a t e r s u p p ly )
A ir S h o w e r
W a re h o u se
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
A ir L o c k 2
W e ig h in g
C le a n C o rrid o r
E m ergenc y
E x it
A ir L o c k 3
S te ril e e y e d ro p s
d isp e n sin g
& a c e p tic fillin g
Slide 27 of 28
M a le
Change 2
May 2006
F e m a le
Change 2
P a c ke d
G oods
Q u a ra n ti n e
M a le
Change 1
E q u ip m e n t W a sh
HVAC
2 S ta g e
p e rso n n e l
e n try fo r
e y e d ro p s
F e m a le
Change 1
A ir L o c k 4
P rim a ry & S e c o n d a ry
P a c kin g
S e rv i c e R o o m
HVAC
Group Session modified layout
S a m p lin g
Rooom
20P a
S e rv i c e C o rrid o r
0P a
( c o n t a in s V a c u u m & R O w a t e r s u p p ly )
30P a
A ir S h o w e r
20P a
10P a
M AL 2
W a re h o u se
0P a
W e ig h
B o o th
20P a
30P a
P o st
S ta g in g
T a b le t 1
30P a
T a b le t 2
15P a
S o ftg e l C a p su le
P a c kin g
L iq u id s M ix
15P a
30P a
M AL1
A ir L o c k
15P a
30P a
C l e a n C o rri d o r
E m ergenc y
E x it
20P a
PAL
M AL 3
40P a
40P a
S te rile e y e d ro p s
d isp e n sin g
& a sc e p tic fillin g
20P a
M a le
Change 2
F e m a le
Change 2
10P a
60P a
15P a
E q u ip m e n t W a sh
M AL 4
Change
50P a
50P a
10P a
M a le
Change 1
F e m a le
Change 1
10P a
P a c ke d
G oods
Q u a ra n tin e
A ir L o c k 4
0P a
0P a
Slide 28 of 28
May 2006
S e c o n d a ry
P a c kin g
20P a
P rim a ry
P a c kin g
30P a
S e rv i c e R o o m
0P a