1.0
OBJECTIVE
To lay
down the procedure for cleaning, operation &
calibration of laminar airflow.
2.0
SCOPE
This
SOP shall be applicable for cleaning, operation &
calibration of laminar airflow in Microbiology Laboratory.
3.0
RESPONSIBILITY
3.1
Microbiologist and above shall be responsible for
the preparation and execution of this SOP
3.2
QC & QA Head shall be responsible for the checking and approval of this
SOP.
4.0
ACCOUNTABILITY
Head QC
5.0
PROCEDURE
5.1
Cleaning
5.1.1
Ensure that the power supply to the LAF is switched ‘OFF’ before
cleaning. Plug shall be removed from the socket.
5.1.2
The working bench surface of LAF shall
be mop with freshly prepared 70 % IPA with a clean non-fiber shedding cloth.
5.1.3
Outer and inside surface of
LAF shall be mop with 70 % IPA solution with non-fiber shedding cloth.
5.1.4
Frequency: Before and
after any work.
5.2
Cleaning of filters:
5.2.1
Laminar airflow has two filters i.e. Pre-filter and HEPA
filter (High-Efficiency Particulate Air Filter).
5.2.2
In case the Magnehelic gauge indicates the filter chocking,
the Pre-filter shall be cleaned using a vacuum cleaner.
5.2.3
Pre-filter shall be checked once in three months for
accumulation of dust.
5.2.4
Pre-filters shall be washed with a mild detergent and dried,
if excessively dirty.
5.2.5
HEPA filter shall not be touched or opened by the laboratory
personnel.
5.2.6
An authorized service engineer who shall also check for any
rupture of the HEPA filters shall be service
the LAF bench annually.
5.3
Operation
5.3.1
Ensure for the cleanliness of the instrument.
5.3.2
Ensure that Switch “ON” the power supply.
5.3.3
There are three switches for
Air flow, U.V light, & normal light respectively and a magnehelic gauge on
the panel of the instrument.
5.3.4
The knobs of the U.V. lamp
and Airflow shall be turned to ‘ON’ position for 30 min. before start of work.
5.3.5
After 30 min.
switch “OFF” the U.V lamp and work shall be started.
5.3.6
Ensure for the Magnehelic
gauge, the level of a red oil indicator
should be between the 10.0 to 15.0 mm mark when the unidirectional flow is
"ON".
5.3.7
After completion of work in LAF bench, again clean it with
70% IPA.
5.3.8
Ensure for the knobs of Airflow and
light to 'OFF' position and put 'OFF' the main switch of LAF.
5.3.9
The details like U.V light burning hours, pressure, cleaning,
instrument switch on/off shall be record.
5.4
Monitoring of microbial contamination
5.4.1
Media required Nutrient agar (NA)/Soyabean Casein Digest Agar
(SCDA) for bacteria and Sabouraud's dextrose agar (SDA) for fungi.
5.4.2
Rehydrate the dehydrated media as per the manufacturers the instruction given on the bottle label and sterilize at 15 Lbs, 121 0C for 20
minutes or as per validated cycle Dispense about 20-25 ml of the media into
sterile Petri dishes and allows to solidify.
5.4.3
Ensure that switch on the LAF & follow point 5.1.
5.4.4
Before working in LAF hands shall be rinsed with 70% IPAv/v
and wear a nose mask and hand gloves.
5.4.5
Place 5 pre-incubated Nutrient Agar/SCDA plates and 5 pre-incubated
Sabouraud's dextrose Agar plates, one on each corner and one in the center of
the LAF bench.
L1 L2
L5
L4 L3
5.4.6
Ensure that the plates shall be open with taking care not to
introduce any extraneous contamination into the media and expose for 30
minutes.
5.4.7
After exposure, the plates shall be cover with the lids and
number them appropriately so as to indicate the position of the plate on the
LAF bench.
5.4.8
Media plates shall be incubated at 300C - 350C for 48-72 hours and further
for 48-72 hrs at 20-25°C.
5.4.9
Also, incubate one plate of each media at the same temperature
for the same time to serve as a negative control.
5.4.10 After incubation, ensure for
the plates for growth and observation shall be recorded.
(as
per Annexure - I).
5.4.11 If no bacterial or fungal
growth is observed, then the LAF is OK.
5.4.12 If any growth is observed,
repeat the monitoring twice.
5.4.13 If growth is still persistent, stop using the
LAF with immediate effect and inform the Engineering
department/supplier
for rectification.
5.5
Frequency of monitoring
5.5.1
Once in 15 days and
after every maintenance job by exposing a sterile media plate.
5.5.2
Calibration of air
velocity & integrity testing of HEPA filter is done on contract every year.
6.0
REFERENCES
N.A
7.0
ANNEXURE
|
Annexure No. |
Title of the Annexure |
Format No. |
|
Annexure I |
Calibration record of LAF |
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8.0
ABBREVIATIONS :
SOP : Standard Operating
Procedure
QCD : Quality Control Department
EQP : Equipment
Dept. : Department
QC : Quality Control
QA : Quality Assurance
QCD : Quality Control Department
No. : Number
N.A : Not Applicable
LAF : Laminar Air Flow
I.P.A : Isopropyl Alcohol
HEPA : High Efficient Particulate Air
SCDA : Soybean Casein Digest Agar
ANNEXURE: CALIBRATION RECORD OF LAMINAR AIR FLOW BY PLATE COUNT METHOD
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Inst.ID:- |
Make:- |
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Date |
Location |
Result
after48 hrs at 30 - 350 C (cfu) |
Result
after further 72 hrs at 20 - 250 C (cfu) |
Done
By
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Medium Used :
Plate Exposed
For : 30 Minutes
Plate
Incubated At : 32.5 °C / 22.5 °C
+ 2.5 °C
Plates
Incubated For : 48 Hrs. / 5 Days
Frequency : Once In 15 Days
Note: Limits : No Growth Should Be Observed In Any Plate.
Remark: The above mentioned laminar flow is working / not
working satisfactorily.
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