Environmental
monitoring of LFH
1. Purpose:-
To describe the method of
environmental monitoring of Laminar Air Flow Hood (LFH).
2. Scope:-
It is 15.04.2015 applicable for all Laminar Air Flow Hoods (LFHs) present in
all clean rooms of Production and Microbiological Lab.
3. HSE
Statement:-
Proper gowning technique should
be followed.
4. Responsibilities:-
i)
Manager Quality Control is responsible
to ensure that procedure & formats are followed entirely as approved.
ii)
Microbiologist is responsible to perform the
test.
5. Materials:-
5.1 Anemometer
5.2 Non-viable Laser Air Particle Couter.
5.3 70% IPA filtered
5.4 Fine dusters
5.5 SS-tray
5.6 Sterile Swabs and Sterile
phosphate buffer pH 7.2
5.7 Surface Air sampler
5.8 Sterile and pre-incubated Tryptic
Soya Agar plates
6. Definitions:-
6.1 LFH: - Laminar airflow cabinets are designed to
direct particles away from the work surface
(This is often supported by airflow or smoke
studies).The term 'LAF' is becoming increasingly
replaced by UDAF
or uni-directionalair-flow
6.2 Environmental
monitoring:
A
documented series of sampling and testing in controlled environments in order
to
Demonstrate conformance to a series
of pre-set limits or for trends.It is distinct from environmental control.
6.3 Air Sampling:-
The collection a sample of air; can be physical (the collection and estimation
of the number of airborne particles, normally called particle counting) or
viable (the estimation of the number of viable micro-organisms are either
deposited onto a settle plate - passive sampling - or collected from a defined
volume of air - active / volumetric air-sampling using an air-sampler.
6.4 Air velocity: -
A value indicating the speed of the air
movement in a clean room or clean zone. It is an indicator of the ability of a
unidirectional-flow clean room to purge itself.
6.5 Particle counter:-
A device
which measures the number of airborne particles of a given size by passing
a sample of air through a focused light source. The presence of a particle
causes dispersion of the
light and the presence of a particular
size can be detected using pre-defined criteria. At BPL two
sizes
of particles are measures: 0.5μm (a close approximation of the size of a
bacterium)
and 5.0μm
(a close approximation of the size of a human skin cell).
7.Flow Chart:-
8. Description:-
8.1 Procedure:-
8.1.1 Microbiological Monitoring of LFHs: -
8.1.1.1 Perform
surface swab test of following parts of LFH in following order as per SOP
8.1.1.2 Sheets,
covers or walls
8.1.1.3 Side
Grills of HEPA filter of LFH
8.1.1.4 Working
bench or table
8.1.1.5 Machine
parts or other accessories
8.1.1.6 Expose
settle plates for 4 hours under LFH at designated points as per SOP.
8.1.1.7 Perform
surface air sampling of LFH as per SOP.
8.1.2 Determination of Airflow velocity:-
8.1.2.1 Check
the battery of anemometer. If low, replace the battery. Also check the
anemometer for its
proper working.
8.1.2.2
Wipe the anemometer with duster
dipped in 70% filtered IPA. Care should be taken with probe whilst wiping the
probe.
8.1.2.3
Place the anemometer in SS-tray
already wiped with 70% filtered IPA.
8.1.2.4
Transfer the SS-tray to the area
to be tested and place the SS-tray in pass through under UV- light for at least
20-30 minutes.
8.1.2.5
Take the anemometer out of SS-tray
and again wipe with duster dipped in 70% filtered IPA.
8.1.2.6
Divide the work zone of LFH into 5
equal parts as shown below:
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1
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2
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3
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4
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5
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8.1.2.7
Orient the probe perpendicular to
the air flow at a distance of not more than 150mm (6 inches) from the HEPA
filter or 1 foot above the work surface. All test positions should be within
unobstructed airflow. Measure the airflow velocity at each test position.
8.1.2.8
For unidirectional airflow system,
take the readings form single HEPA filter at designated points shown above. For
non-unidirectional airflow system, take the readings form each HEPA filter
separately at designated points shown above.
8.1.2.9
Orient the probe at the specified
location until a stable reading is obtained and record the average reading.
8.1.3 Non-viable Air Particle Count:-
8.1.3.1 Charge
and check the non-viable particle counter for its proper working.
8.1.3.2 Wipe the
non-viable particle counter and its probe with duster dipped in 70% filtered
IPA.
8.1.3.3 Place
the equipment in SS-tray already wiped with 70% filtered IPA.
8.1.3.4 Transfer the SS-tray to the area to be tested
and place the SS-tray in pass through under UV- light for at least 20-30
minutes.
8.1.3.5
Take the equipment out of SS-tray
and again wipe with duster dipped in 70% filtered IPA.
8.1.3.6
Set up the non-viable particle
counter by attaching the probe to non-viable particle counter in its port.
8.1.3.7
Record the name of operator(s)
working in the clean air device being tested and their activity at the time of
testing.
8.1.3.8 Position the probe isokinetically in relation to the air flow
(facing the air flow). Particle counter should be positioned at 1 foot above
the working level.
8.1.3.9
Run the particle counter. Observe
the first count to ensure the particle counter is operating correctly and
discard the reading.
8.1.3.10
Take the consecutive three reading
for 0.5μm particles by moving the particle counter in entire area so that all
area is sampled for non-viable particle count. Sampling time must be 1 minute
for each reading If there are more than one HEPA filters in a LFH, take the
separate readings for each filter as described above
8.1.3.11
Take the average of readings for
both particles.
8.1.4
Air Sampling:-
8.1.4.1
Charge and check the air sampler
for its proper working prior to use..
8.1.4.2
Wipe the air sampler with duster
dipped in 70% filtered IPA.
8.1.4.3
Place the equipment in SS-tray
already wiped with 70% filtered IPA.
8.1.4.4
Transfer the SS-tray to the area
to be tested and place the SS-tray in pass through under UV- light for at least
20-30 minutes.
8.1.4.5
Take the equipment out of SS-tray
and again wipe with duster dipped in 70% filtered IPA.
8.1.4.6
Open the lid of air sampler and
adjust a prepared sterilized Agar plate within the grooves of air sampler and
screw up the lid.
8.1.4.7
Turn on the air sampler it
automatically turns to operating page within 3 seconds.
8.1.4.8
Now input the sampling air volume
which is 1cubic meter (Equivalent to 1000liter)
8.1.4.9
Push ENTER, it starts to sample.
8.1.4.10
Take the samples of air from three
different locations by moving the air sampler in entire area under LFH so that
all area is sampled for viable particle count. If there are more than one HEPA
filters in a LFH, take the separate readings for each filter as described above
8.1.4.11
Incubate these plates at 32.50C for 48-72 hrs and note down the results.
8.2 Specifications:-
8.2.1 Microbiological Monitoring: Area
under LFH should comply with specifications of surface swab test; settle plate
method and surface air sampling as per SOP.
8.2.2
Velocity: The air
flow velocity of LFH should not be less than 90fpm (0.45m/s) + 20%.
8.2.3
Non-viable Air Particle Count: NMT 3500 particles of 0.5-5.0μm should be observed under
LFH.
8.2.4
Viable
Particle count: Less than 1cfu.
8.3 Frequencies:-
8.3.1 Settle
Plate Method: Each Operating
Shift or as and when required
8.3.2 Surface
Swab Test: Monthly or as
and when required
8.3.3 Surface
Air Sampling: Monthly
or as and when required
8.3.4 Airflow Velocity: Monthly or as and when
required
8.3.5 Non-viable Air
Particle Count: Monthly or as
and when required
9. Records:-
9.1 Aseptic Area
Monitoring (SPM and SAS) – Ampoule and IV Infusion Area
9.2 Aseptic Area
Monitoring (SPM and SAS) – Vial Filling Area
9.3 Area
Monitoring of Sterility Testing Suit
9.4 AC/CFM/LV
Monitoring Log
9.5 Non-viable Air Particle Count Report
10 References
10.1 ISO 14644-3:2005, Clean rooms and associated controlled
environments.
10.2 FDA, Guidance for
Industry, Sterile Drug Products Produced by Aseptic Processing — Current
Good Manufacturing Practice, September 2004.
10.3 Syed Imtiaz Haider, Validation Standard Operating Procedures A
Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical
Device, and Biotechnology Industries,
2nd edition, Taylor & Francis Group, LLC , USA
10.4 Guidelines on the Test
Methods for Environmental Monitoring for Aseptic Dispensing Facilities,
Produced by: A Working Group of Scottish Quality Assurance Specialist Interest
Group, Feb 2004.
11.Distribution:-
This SOP has to be distributed in below mentioned
Departments:-
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Sr. NO
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Distributed to
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Received
(Current)
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Returned
(Obsolete)
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1
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Quality Control
Department
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2
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Quality Management
Department
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12.
Revision History:-
Date Changes
N/A