hvac | slide 1 of 27 2013 heating, ventilation and air- conditioning (hvac) part 4: commissioning,...
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HVAC | Slide 1 of 27 2013
Heating, Ventilation and Air-
Conditioning (HVAC)
Part 4:
Commissioning, qualification and
maintenance
Supplementary Training Modules on Good Manufacturing Practice
Section 8
WHO Technical Report Series, No. 961, 2011. Annex 5
HVAC | Slide 2 of 27 2013
HVACHVAC
Objectives
To understand key issues in
commissioning,
qualification and
maintenance of HVAC systems
8.
HVAC | Slide 3 of 27 2013
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
Documentation requirements to assist in commissioning, qualification and maintenance
HVAC
HVAC | Slide 4 of 27 2013
HVACHVAC
Commissioning
Commissioning (is integrated in qualification) and includes:
Setting up, balancing, adjustment and testing of entire HVAC system
It helps to ensure it meets URS and capacity
Acceptable tolerances for parameters set before commissioning
Precursor to qualification8.1.1, 8.1.4, 8.1.6
HVAC | Slide 5 of 27 2013
HVACHVAC
Commissioning (2)
Records and data include:
Installation records – documented evidence of measured capacities of the system
Acceptance criteria set for system parameters
Training of personnel (e.g. operation and maintenance)– O&M manuals, schematic drawings, protocols, reports
8.1.2, 8.1.3, 8.1.5
HVAC | Slide 6 of 27 2013
HVACHVAC
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.
Risk-based approach for HVAC qualification
See also full guidelines on "Validation" in WHO TRS No 937, 2005, Annex 4.
8.2.1
HVAC | Slide 7 of 27 2013
HVACHVAC
Qualification
Described in a Validation Master Plan (VMP)
Reflects the nature and extent, test procedures, 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 8 of 27 2013
HVACHVAC
Qualification
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
8.2.6 - 8.2.11
HVAC | Slide 9 of 27 2013
HVACHVAC
Design conditions and normal operating ranges set to achievable limits
OOL results recorded and investigated
8.2.10 – 8.2.12
A C TIO N LIM IT
A LERT LIM ITA LERT LIM IT
A C TIO N LIM IT
O perating Range - Validated Acceptance Criteria
Norm al O perating Range
Design Condition
HVAC | Slide 10 of 27 2013
HVACHVAC
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 11 of 27 2013
HVACHVAC
Qualification
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)
8.2.13
HVAC | Slide 12 of 27 2013
HVACHVAC
Qualification
Typical parameters to be included in qualification (based on risk assessment) (2):
Room air flow patterns
Room clean-up rate
Particulate matter, microbial matter (viable and non-viable)
HEPA filter penetration tests
Containment system velocity
Warning/alarm systems 8.2.13.
HVAC | Slide 13 of 27 2013
HVACHVAC
Conduct of the tests:
Time intervals and procedure to be defined by the manufacturer - based on risk assessment (influenced by the type of facility and level of protection)
See also ISO 14644 for procedures
Requalification, and change control
Documents: system airflow schematics, room pressure cascade drawings, zone concept drawings, air-handling system allocation drawings, particle count mapping drawings
8.2.14 – 8.2.18
HVAC | Slide 14 of 27 2013
HVACHVAC
Qualification
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 15 of 27 2013
HVACHVAC
Schedule of tests to demonstrate continuing compliance
*Test procedure as per ISO 14644 8. Table 3
Test ParameterObjectiveConsiderationsTest procedure* and key aspects
Particle count testVerifies cleanlinessNumber of readings and positions
Particle counter. Readings and positions
Air pressure difference
Absence of cross-contamination
Continuous. Defined limits
Measure pressure difference
Airflow volumeVerify air change rates
See ISO 14644Measure supply and return air, calculate air change rate
Airflow velocityVerify unidirectional airflow and or containment condition
Velocity and containment
Velocity measurement
HVAC | Slide 16 of 27 2013
HVACHVAC
Recommended optional strategic tests
*Test procedure as per ISO 14644 8. Table 3
Test ParameterObjectiveConsiderationsTest procedure* and key aspects
Filter leakageVerify filter integrityFor HEPA filtersFilter media and filter seal integrity
Containment leakageVerify absence of cross-contamination
Containment, smoke and air pressure
Airflow direction and pressure differential
Recovery (time)Verify clean-up timeCertain classesTime taken maximum 20 minutes
Airflow visualizationVerify required airflow patterns
Clean to dirty area, uniformly. Video
Airflow direction, documented evidence
HVAC | Slide 17 of 27 2013
Cleanroom monitoring program (1)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
HVAC | Slide 18 of 27 2013
Cleanroom monitoring programme (2)Particles and Microbiological contaminants
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
HVAC
See also ISO 14644
HVAC | Slide 19 of 27 2013
Cleanrooms should be monitored for microorganisms and particles
HVAC
S e rv i c e R o o m
W a re h o u se
A/ L
ock 1
Air L
ock 2
A i r S h o w e r
S a m p l i n gR o o o m S e rv i c e C o rr i d o r
(contains Vacuum & RO water supply)
W e i g h i n g T a b l e t 1 T a b l e t 2 L i q u i d s M i x S o f t g e l C a p su l eP a c ki n g
Em ergencyExit
C l e a n C o rr i d o r
E q u i p m e n t W a sh
A i r L o c k 3
S t e ri l e e y e d ro p sd i sp e n si n g
& a c e p t i c f i l l i n g
2 S t a g ep e rso n n e l
e n t ry f o re y e d ro p s
M a l eC h a n g e 2
M a l eC h a n g e 1
F e m a l eC h a n g e 1
F e m a l eC h a n g e 2
P a c ke dG o o d s
Q u a ra n t i n e
A i r L o c k 4
P ri m a ry & S e c o n d a ryP a c ki n g
Example of a sampling points
HVAC | Slide 20 of 27 2013
Qualification – examples of aspects to consider in qualification (OQ, PQ)
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)
HVAC
HVAC | Slide 21 of 27 2013
HVACHVAC
Maintenance
Procedure, programme and records for planned, preventative maintenance
– e.g. cleaning of filters, calibration of devices
Keep O&M manuals, drawings etc.
Appropriate training for personnel
Change of HEPA filters by suitably trained persons
Impact of maintenance on:– Product quality and Qualification
8.3.1 – 8.3.6
HVAC | Slide 22 of 27 2013
HVACHVAC
Premises may influence HVAC design / performance. Therefore consider:
Adequate airlocks, change rooms, passages
Required pressure cascades
Detailed diagrams available with pressure cascades, air flow directions and flow routes for personnel and materials should be prepared and maintained;
Change room classification9
HVAC | Slide 23 of 27 2013
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)
Inspecting the air-handling system
HVAC
HVAC | Slide 24 of 27 2013
Appropriate design of AHUs and HVAC system
Correct components, and MOC
Ensuring appropriate cleanliness of air, environmental conditions
(e.g. temperature and RH), and area classification to prevent
contamination and cross-contamination
Qualification data to support claims
Regular calibration, maintenance and cleaning
Take home message. What is essential?
HVAC
HVAC | Slide 25 of 27 2013
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
Conclusion
HVAC
HVAC | Slide 26 of 27 2013
Group Session
S e rv i c e R o o m
W a re h o u se
A/ Lo
ck 1
Air L
ock 2
A i r S h o w e r
S a m p l i n gR o o o m S e rv i c e C o rr i d o r
(contains V acuum & RO water supply)
W e i g h i n g T a b l e t 1 T a b l e t 2 L i q u i d s M i x S o f t g e l C a p su l eP a c ki n g
Em ergencyExit
C l e a n C o rr i d o r
E q u i p m e n t W a sh
A i r L o c k 3
S t e ri l e e y e d ro p sd i sp e n si n g
& a c e p t i c f i l l i n g
2 S t a g ep e rso n n e l
e n t ry f o re y e d ro p s
M a l eC h a n g e 2
M a l eC h a n g e 1
F e m a l eC h a n g e 1
F e m a l eC h a n g e 2
P a c ke dG o o d s
Q u a ra n t i n e
A i r L o c k 4
P ri m a ry & S e c o n d a ryP a c ki n g
HVAC
HVAC | Slide 27 of 27 2013
Group Session – modified layout
S e c o n d a ryP a c ki n g
30P a
0P a
20P a 30P a
0P a0P a
10P a
10P a 10P a
20P a20P a
40P a
50P a
60P a
50P a
40P a
15P a
15P a
P ri m a ryP a c ki n g
C h a n g e
M A L 3
A i r L o c k
30P a
P o stS t a g i n g
30P a
30P a
0P a
15P a15P a
20P a
20P a
30P a
20P a
0P a
10P a
S e rv i c e R o o mA i r L o c k 4
P a c ke dG o o d s
Q u a ra n t i n e
F e m a l eC h a n g e 2
F e m a l eC h a n g e 1
M a l eC h a n g e 1
M a l eC h a n g e 2
P A L
S t e ri l e e y e d ro p sd i sp e n si n g
& a sc e p t i c f i l l i n g
M A L 4
E q u i p m e n t W a sh
C l e a n C o rr i d o rEm ergency
Exit
S o f t g e l C a p su l eP a c ki n gL i q u i d s M i xT a b l e t 2T a b l e t 1
W e i g hB o o t h
(contains V acuum & RO water supply)S e rv i c e C o rr i d o r
S a m p l i n gR o o o m
A i r S h o w e r
MAL
2
MAL
1
W a re h o u se
MAL = Material Air Lock
PAL = Personnel Air Lock
HVAC