1. Purpose:-
To determine the efficiency
of routine cleaning procedures and to evaluate that area is free from any
contamination that permits the microbial growth.
2. Scope:-
This procedure is
applicable to sterile surfaces and equipments present in clean rooms of Liquid
Injectable and IV Infusion filling areas of Production department and Sterility
Testing Suit of 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
swab test.
iii)
Lab attendant is responsible
to assist the officer microbiologist for the preparation of test materials.
5. Materials:-
5.1 Sterile cotton
swabs in a sterile container
5.2
Small Test tubes containing 10ml sterile 0.9% NaCl saline solution.
5.3
Sterile Petri plates
5.4
Flask containing autoclaved tryptic soya agar
6.5
Test tube rack
5.6
Disinfectant (70% IPA) Spray
5.7
Stainless Steel Tray
6.
Definitions:-
6.1 Swab test
A test to determine the microbial status of regular as well as irregular
surfaces of sterile areas .Swabs are devices provided used to sample surfaces
for the determination of microbial status. The swabs generally composed of a
stick with an absorbent extremity, is moistened before sampling and used to
sample a specified unit area of a surface.
7.0Flow Chart:-
8.0 Description:-
8.1 Procedure:-
8.1.1 Preparation of material for Swab test
8.1.1.1 Take thin SS-rod and wrap firmly
a thin layer of cotton on it.
8.1.1.2 Place the cotton swabs in a
suitable container.
8.1.1.3 Dispense 10ml 0.9% NaCl saline
solution in small test tubes and places them in test tube rack.
8.1.1.4 Cover the test tube rack with the
aluminum foil
8.1.1.5 Autoclave all the materials at
1210C for 15 minutes.
8.1.1.6 Place the mopped SS-tray
containing the material in pass through of the clean room to be tested
under UV
light.
8.1.2
Procedure of taking
Swab sample
8.1.2.1
Before taking sample of any
surface, ensure that the surface is dry.
8.1.2.2
For each surface to be tested,
swab should be removed from container
under laminar air flow hood (LFH).
8.1.2.3
After removing swab, dip it in
labeled test tube containing 0.9% NaCl sterile solution.
8.1.2.4
Wipe the swab over the sample area
in close parallel streaks, using firm even pressure and rotating the swab
between fingers to maximize the sample pick up.
8.1.2.5
The swab should be held at a 300
angle to contact surface.
8.1.2.6
With the same swab, repeat the
process at right angles to first streaks to ensure that the
entire sample
area is swabbed.
8.1.2.7
Place the swab in 0.9% NaCl sterile saline
solution in which it is previously dipped.
8.1.2.8
Area covered by a single swab
should be 25 to 30cm2.
8.1.2.9
Test is performed starting from
most critical place i.e.; machine parts to least critical surfaces.
8.1.2.10
Those areas which are not easily
accessible must be properly tested by inserting swabs in the crevices.
8.1.2.11 After taking
the swab, gather all the samples and place them in SS-tray.
8.1.2.12 Transfer the SS-tray to
Microbiological Lab.
8.1.3 Plating out method for swab samples
8.1.3.1 Samples should be plated under LFH
8.1.3.2 Label the empty sterilized Petri plates
on their lid side according to area from where
sample is taken
8.1.3.3
Aseptically open the swab tube and
pour the whole content of the tube in the Petri plate
8.1.3.4
Take the sterile flask containing
autoclaved molten agar cooled at 400C
and pour about 30ml of agar in each
Petri plate containing swab samples.
8.1.3.5
Rotate the Petri plate once clock
wise and once anti clockwise to mix its content.
8.1.3.6
Swab should be plated out as soon
as possible after sampling. If there is delay, the swab should be stored at room
temperature, but not more than 2 hours
8.1.3.7
A negative swab control should
also be plated. Negative swab control will not contain any sample.
8.1.3.8
Incubate the Petri plates at 32.5+2.5ºC
for 48 -72hours and record
8.2 Specifications:-
For each grade of controlled
areas or clean rooms microbial limits are given below.
Table: Limits* for Microbial
contamination (cfu/25cm2)
‡
Sr. No.
|
Grade / Class
|
At rest
(cfu/25cm2)
|
Operational (cfu/25cm2)
|
1
|
A
|
<1
|
NMT 3
|
2
|
B
|
<1
|
5
|
3
|
C
|
5
|
25
|
4
|
D
|
25
|
50
|
·
Limits are bacterial count. Mold or fungal count
should be considered as zero.
8.3 Frequency:-
Monthly and after
a shut down for a week or more
9. Records
9.1 Surface Swab Test Report
9.2 Area Monitoring of Sterility Testing Room
10. Reference:
10.1 United States
Pharmacopoeia 35.
10.2 Guidelines
on the Test Methods for Environmental Monitoring for Aseptic Dispensing
Facilities, Produced by: A
Working group of the Scottish Quality Assurance Specialist Interest Group, February 2004. (For
All Classes at Rest and Operational B, C and D)
Monthly
and after a shut down for a week or more
11. Distribution:-
This SOP has to be distributed in below mentioned
Departments:-
Sr. NO
|
Distributed to
|
Received
(Current)
|
Returned
(Obsolete)
|
1
|
Quality Control
Department
|
|
|
2
|
Quality Management
Department
|
|
|
12.
Revision History:-
Date Changes
N/A