1.0 OBJECTIVE:
To provide written
procedure for the operation and validation of Anaerobic System
2.0 SCOPE:
This SOP covers
operation and validation of Anaerobic System Mark III (Hi Media) in
Microbiology
Department.
3.0 RESPONSIBILITY:
Microbiologist:
Responsible for operation and validation of instrument as per procedure
and maintain the
record.
QA Officer / QAM:
Review the records and governing the document
4.0 PROCEDURE:
4.1 Ensure that the instrument is clean and free
from dust
4.2 Place the petriplates in the carrier. Disposable
plastic Petriplates should be of the vented
variety to aid gas
transfer between the interior and exterior of the plates.
4.3 Cut open Hi Media’s Anaero Indicator Tablet
sachet (LE001B) and remove one tablet
pack .Insert the
pack into the smaller (upper) clip on the plate carrier immediately.
4.4 Lower
the plate carrier into the Polycarbonate base.
4.5 Read information on
Anaero Gas Pack carefully. Cut off the top of any one required
Anaero Gas Pack
(LE002A-LE002F) as indicated by the cut mark, remove sachet, place it
in
the lower clip of the plates carrier
4.6 Place
the lid on the base making sure that the O- ring is correctly in place (evenly
pressed
against the flange
as a secure fit ). Apply the beam clamp. Screw down the knurled wheel
until tight.
4.7
The Anaerobic Indicator tablet will remain
pink in the jar indicating anaerobiosis. Any
kind of leakage leading to aerobic condition will turn
the colour of tablet to purple.
4.8
After incubation the Anaerobic Indicator
tablet may be discarded with the normal
laboratory litter
4.9 The exhausted Anaero Gas
Pack sachet should be removed without spilling the contents
and discarded
carefully as per instructions printed on the Anaero Gas Pack cover.
4.10 The interior of the lid
and jar should be kept free of dust.
4.11 Plastic dust caps are
provided to prevent dust particles entering the valve core and possibly
interfering with
efficient operation of the spring mechanism.
5.0 ROUTINE MAINTENANCE:
CLEANING
5.1 Anaerobic jar may be cleaned by swabbing
carefully with 70% alcohol.
5.2 If more disinfection is required, 20ml of 10%
formalin solution can be added to the jar and
the anaerobic
system is incubated at 37°C overnight.
5.3 Sodium hypochlorite
or strong detergent solution should be avoided.
5.4 After each use lid
can be cleaned and dried with soft tissue, taking care not to scratch the
surface coating.
5.5 The jars are best
stored open, with the lid inverted, in a warm dry place.
5.6 Care must be taken to
prevent contamination by dust.
5.7 O-ring should be
regularly inspected to make sure that no undue distortion has taken place,
and should be
replaced if there are any sign of splitting or other faults.
6.0 VALIDATION:
6.1 Place the Petri dish streaked with two
cultures namely, Bacillus subtilis and Clostridium in
the center of the
carrier and close the anaerobic jar.
6.2 Place the entire assembly at 37°C in the incubator
for 24-48hrs.Record the growth.
6.3 The anaerobic bacteria Clostridium will show
profuse growth, while Bacillus subtilis will
be inhibited due to lack of oxygen .
7.0 DOCUMENTATION:
Annexure – 1 Anaerobic System usage log
book XXX/FRM/000
Annexure – 2 Validation of Anaerobic System XXX/FRM/000
8.0
HISTORY OF REVISION:
Revision No
|
Effective Date
|
Revision Date
|
Reason for revision
|
Annexure-1
|
||||
Date
|
Booking No
|
Name of sample
|
Used by
|
Sign
|
SOP NO : XXX/SOP/000-00 Format No : XXX/FRM/000-00
|
||||
Annexure-2
|
||||
Validation of Anaerobic System
Validation
Date :
Next Due Date for Validation:
Instrument
ID No:
Make / Model No:
Batch No
of Anaero Gas Pack:
|
||||
Sr. No
|
Cultures Used
|
Media
Used
|
Incubation
Temp/Time
|
Observation
|
1.
|
B.Subtilis (MTCC 441)
|
37°c/24hrs
|
||
2.
|
Clostridium (MTCC 1215)
|
37°c/24hrs
|
||
Remark: Satisfactory / Not Satisfactory
Validated by:
Checked by:
Date:
Date:
|
||||
SOP No: XXX/SOP/000-00 Format No: XXX/FRM/000-00
|
||||
No comments:
Post a Comment