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Supplementary Training Modules on

Good Manufacturing Practice

Heating, Ventilation and


Air-Conditioning (HVAC)
Part 3:
Commissioning, Qualification,
and maintenance

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

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
Slide 3 of 28

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

8.1.1, 8.1.4, 8.1.5

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

O p e r a tin g R a n g e - V a lid a te d A c c e p ta n c e C r ite r ia

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

Particle count test

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

Verify air change


rates

12 months

Measure supply and


return air, calculate
air change rate

Airflow velocity

Verify unidirectional
12 months
airflow and or
containment condition

*Test procedure as per ISO 14644


HVAC

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

Verify filter integrity

12 months

Filter media and filter


seal integrity

Containment leakage

Verify absence of
cross-contamination

12 months

Airflow direction and


pressure differential

Recovery (time)

Verify clean-up time

12 months

Time taken maximum


15 minutes

Airflow visualization

Verify required airflow


patterns

12 months

Airflow direction,
documented evidence

*Test procedure as per ISO 14644


HVAC

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

See also ISO 14644


HVAC

Slide 18 of 28

May 2006

HVAC
Cleanroom monitoring program (3)
Cleanrooms should be monitored for microorganisms and
particles
air

Example of a sampling point


HVAC

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

Differential pressure on filters

Room differential pressure

N/A

2, 3

Airflow velocity / uniformity

2, 3

Optional

Description

1 := As built (ideally used to perform IQ)


2 = At rest (ideally used to perform OQ)
3 = Operational (ideally used to perform PQ)

Airflow volume / rate

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

1 := As built (ideally used to perform IQ)

Room classification (airborne particle)

2,3

2 = At rest (ideally used to perform OQ)

Temperature, humidity

N/A

2,3

3 = Operational (ideally used to perform PQ)

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

Play a major role in the quality of pharmaceuticals


Should be designed properly, by professionals
Should be treated as a critical system

Slide 25 of 28

May 2006

HVAC
Further proceedings
This series of explanations will now be followed by:

HVAC

Group discussion, with a simple exercise


Short test

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

MAL = Material Air Lock


HVAC

PAL = Personnel Air Lock


|

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