1.0 Purpose:-
To determine the efficiency of routine cleaning
procedures and to evaluate whether the area is free from any contamination that
permits microbial growth.
2.0 Scope:-
This procedure is applicable to sterile surfaces
and equipment present in clean rooms of Liquid Injectable and IV Infusion
filling areas of the Production department and Sterility Testing Suit of the Microbiological Lab.
3.0 Statement:-
The proper gowning technique should be followed.
4.0 Responsibilities:-
The Quality Assurance (QA) department is responsible for developing and maintaining this SOP.
The QA department is also responsible for training personnel on the procedure.
The production staff is responsible for collecting and submitting surface swab samples to the QA
department.
5.0 Materials:-
Sterile swabs
Sterile test tubes
0.9% saline solution
Petri dishes
Incubator
Microscope
Disinfectant (70% IPA) Spray
A flask containing autoclaved tryptic soya agar
Test tube rack
Stainless Steel Tray
6.0 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, are moistened before sampling and used to sample a specified unit
area of a surface.
7.0 Records
7.1 Surface Swab Test Report
7.2 Area Monitoring of Sterility Testing
Room
8.0 Description:-
8.1 Procedure:-
8.1.1 Preparation of material for a Swab
test
8.1.1.1 Take a 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 a 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 1210 C for
15 minutes.
8.1.1.6 Place the mopped SS tray containing the
material in the 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 a sample of any surface, ensure that the surface is dry.
8.1.2.2 For
each surface to be tested, the swab should be removed from the container
under a laminar air flow hood (LFH).
8.1.2.3 After
removing the swab, dip it in a 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 the surface.
8.1.2.6 With
the same swab, repeat the process at right angles to the first streaks to ensure
that the
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 the most critical place i.e.; machine parts to the 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 the SS tray.
8.1.2.12 Transfer the SS-tray to Microbiological
Lab.
8.1.3 Plating out the 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 the area from where the sample is taken
8.1.3.3 Aseptically
open the swab tube and pour the whole content of the tube into the
Petri plate
8.1.3.4 Take
the sterile flask containing autoclaved molten agar cooled at 400 C and
pour about 30ml of agar in each Petri plate containing swab samples.
8.1.3.5 Rotate
the Petri plate once clockwise 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 a 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 AnalysisIncubate the plate at 35 degrees Celsius for 24 hours.
Count the number of colonies that grow on the plate.
Report the number of colonies per square centimeter to the appropriate personnel.
8.3 Specifications:-
For each grade of controlled areas or clean
rooms, microbial limits are given below.
Table: Limits for Microbial
contamination (cfu/25cm2) ‡
8.4 Frequency:- Limits
are bacterial count. Mold or fungal count should be considered zero.
Monthly and after a shutdown for a week or more
|
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 |
9.0 Reference:
9.1 United States Pharmacopoeia
35.
9.2 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)
END OF THE DOCUMENT
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