1.0
OBJECTIVE
To lay down
the procedure for swab sampling for validation of test surface to evaluate
cleaning efficacy.
2.0
SCOPE
This SOP shall be applicable for all the test surface validations for evaluating the efficiency of the cleaning procedures in the Microbiology Lab.
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 Assemble the swabs required and
ensure that the correct information is written on the label of each tube (eg:
date of collection, area/site of the collection)
5.2
Ensure that the swabs dipped in 10 ml sterile saline solution
aseptically and shall be carried in a SS container to the production area.
5.3
Ensure for the strictly following the dress code then enter
in the sampling area.
5.4
Before testing any surface ensure that it is dry and disinfectant
with 70% I.P.A.
5.5
Ensure for the squeeze out the pre-moistened
swab on the wall of the tube properly and the sample area shall be a wipe of 25
cm2 (defined by means of the stainless steel template) in close
parallel streaks, using firm even pressure and rotating the swab between
fingers to maximize sample pick up.
5.6
In the case of irregular surfaces, it shall wipe the same number of times.
5.7 The swab shall be held at a 30º angle to the contact surface.
With the same swab, repeat the process at the right angle to the first streaks to
ensure that the entire sample area is swabbed.
5.8
Swab shall be replacing into transparent tube ensuring that
swab comes into contact with the solution by pushing downward hard.
5.9
The SS template shall be removed from the sampled and clean with
a suitable disinfectant eg: 70% IPA to remove any possible contamination.
5.10
This process shall be repeated as required for each sampling
position.
5.11
A negative control swab shall be carried out at the end of the
sampling by just squeezing out the swab and replacing it back in the solution.
5.12 A positive control swab shall be carried out in a similar way
by sampling a known “dirty surface”.
5.13
All swab samples shall be collect together and manipulate further
as directed below under “Plating out the method for swabs”
5.14
Plating out the method for
swabs:
5.14.1
After bringing the swab back to the microbiology lab filter 10 ml
of normal saline containing swab sample shall be filtered to 0.45 µ filter and
place the membrane on pre-incubated SCDA Plates.
5.14.2
The above plates shall be incubated at 30-35ºC for 48 hours
for bacteria and at 20-25ºC for 72 hours for fungus.
5.14.3
CFU present in each plate shall be count and record the
result as CFU /25 cm2 at each sampling point.
6.0
REFERENCES
N.A
7.0
ANNEXURE
N.A
8.0
ABBREVIATIONS :
SOP : Standard Operating Procedure
GEN : General
Dept. : Department
QC : Quality Control
QA : Quality Assurance
QCD : Quality Control Department
No. : Number
N.A : Not Applicable
Lab : Laboratory
CFU : Colony Forming Unit
IPA : Iso Propyl Alcohol
SS : Stainless steel
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