1.0 Objective:
1.1 To lay down the procedure for Sampling and testing procedure of swab sample.
2.0 Scope:
2.1 This SOP is applicable for Sampling and testing procedure of swab sample in the Microbiology lab of pharmaceutical formulation plant.
3.0 Responsibility:
3.1 Officer or above of Microbiology laboratory: Preparation of the SOP.
3.2 Head – Microbiology section/ Nominee: Checking of the SOP.
4.0 Accountability:
4.1 Head – Quality Control/ Nominee: Compliance of SOPs.
5.0 Procedure:
5.1 Prepare the sterile swab in 0.9%
saline (10 ml) solution in the test tube having cotton plug or use readymade
sterile moisten swab (Hi media).
5.2 Sterile the swab media in the
autoclave by operating the autoclave as per respective SOP.
5.3 The swabbing shall be done on the
area of 100 cm2 by following horizontal strokes first followed by vertical
strokes.
5.4 Place the swab back in the test
tube and vortex. Incase of readymade sterile moisten swab pour about 10 ml of
0.9% saline in tube and vortex.
5.5 Filter the content through 0.45µ
membrane filter and place the filter on the Petri plate having sterile SCDA
medium.
5.6 Incubate the plate at 30 – 35 º C
for 48 hrs and further at 20 – 25 º C for 72 hrs.
5.7 Count the colonies and report the
total microbial count as CFU/100 cm2 in Annexure-I.
6.0 List of Annexure / Formats
|
Sr. No.
|
Format Title
|
Format Number
|
Annexure Number
|
No. of Pages
|
|
1
|
Report for Total Microbial Count of
swab sample
|
|
|
|
7.0 References (if any).
7.1 Not applicable.
8.0 Reason for Revision
8.1 Periodic Review.
9.0 Abbreviations:
9.1
SOP : Standard operating
procedure.
9.2
No. : Number
9.3
QC : Quality
Control
9.4
QA : Quality
Assurance
9.5
CFU : Colony Forming Unit
9.6 SCDA
: Soyabean Casein Digest Medium
Annexure-I
Report for Total Microbial Count of swab sample
|
Name of
Sample : __________________________________
Date of
Sampling : __________________________________
Date of
Testing : __________________________________
Date of
Report : __________________________________
|
Area/Location:
____________
|
||||
|
TOTAL
MICROBIAL COUNT : (Membrane Filtration Method)
Medium
Used : ___________________ Autoclave Lot No.:
__________________________
For
Bacteria:
Incubation
Condition : Temp _______, Time : From _____________to____________
Incubator
ID No.:_____________________
For
Fungus:
Incubation
Condition : Temp _______, Time : From _____________to____________
Incubator
ID No.:_____________________
|
|||||
|
Date of
testing
|
Location
ID
|
Observation
|
cfu/100
cm2
|
||
|
Bacteria
|
Fungus
|
||||
|
Interpretation:
Sample Complies/Does not comply as per respective SOP.
|
|||||
|
Sr. No.
|
Grade
|
Acceptable
level of Total Microbial Count (cfu/100 cm2)
|
|||
|
01
|
A
|
<1
cfu/100 cm2
|
|||
|
02
|
B
|
NMT 5
cfu/100 cm2
|
|||
|
03
|
C
|
NMT 50
cfu/100 cm2
|
|||
|
04
|
D
|
NMT 100
cfu/100 cm2
|
|||
|
05
|
Fungus
|
NMT 10
cfu/100 cm2
|
|||
