1. Purpose:-
To evaluate the microbial status of personnel’s
gloves by using finger dab plates..
2. Scope:-
This procedure is applied
to all the operators/personnel’s involved in aseptic products filling in liquid
injecables, IV Infusion and Sterile powder filling area of production
department and also to operator working in sterility testing room of
Microbiological Lab.
3. HSE
Statement:-
Not Applicable.
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 Flask
5.2 N-agar or Tryptic Soya Agar (TSA)
5.3 Hot plate and Stirrer
5.4 SS-tray
5.5 70% IPA Spray
5.6
Petriplates (90mm)
6.
Definitions:-
6.1 Finger Dab Test:-
Finger Dab
Test is used to show a breakdown in operator aseptic technique where operator
touches a contaminated surface e,g face when adjusting mask and contamination
is transferred to operators hands and then to products or materials that are
handled in critical work zone.
In addition, finger dab test can be used
to evaluate operator training.
7.0 Flow Chart:-
8 Description:-
8.1 Preparation of Media
8.1.1
Weigh desired amount of agar medium (e.g.; Nutrient agar or TSA) in a screw cap
flask.
8.1.2
Dissolve agar medium in calculated volume of distilled water according to manufacturers
instruction
and boil to dissolve completely.
8.1.3 Tight the
cap of the flask and autoclave the medium at 1210C for 15min.
8.1.4 Take clean
and washed petriplates. Sterilize the petriplates in hot air oven at 2000C
for 2 hours.
8.1.5
Allow petriplates to cool at room temperature (20-250C).
8.1.6
Pour molten and autoclaved agar medium cooled at 400C in sterile
petriplates by lifting the lid of
Petriplate. Agar Medium should be poured under LFH.
8.1.7 Allow agar medium to solidify.
8.1.8 After solidification, incubate each petriplate in inverted
position for 48-72 hours at 32.5+2.50C.
8.1.9 Examine each petriplate for contamination after incubation. Contaminated
petriplates disposed off.
Use only sterile petriplates for the
test.
8.1.10
Mop each petriplate from outside
with a clean duster dipped in 70% IPA and label the plates by
dividing the plate in two equal halves (each half for
each hand) with operator’s name and date
mentioned.
8.1.11
Place all the petriplates in a
SS-tray properly mopped with 70% IPA and transport it place of test.
8.1.12
During transportation, do not open the lid of
SS-tray.
8.1.13
Place the SS-tray in Pass Through under UV
Light for 30 minutes.
8.2 Monitoring of Personnel Gloves
8.2.1
Sample should be taken at the end of a work session prior to operator
carrying out any cleaning
operations.
Before performing the test the operator should ensure that gloves are dry and
free of any
disinfectant.
8.2.2 The
operator should lift the lid of the plate, with the opposite hand being tested,
and keeping hold of
the
lid in the hand, touch the agar surface with the tips of all fingers then the
thumb of the hand
being tested.
8.2.3 A firm
and even pressure should be applied for approximately 5 to 10 seconds by taking
care not to
damage
the agar surface.
8.2.4 For personnel working in Class A, The whole
procedure should be done under Laminar Air Flow
Hood (LFH).
8.2.6 Replace the lid of plate. Repeat the same process for the other
hand
8.2.7 After that take the SS-tray to Microbiological Lab and incubate
the plates for 48-72hours at 35+20C
and record the results.
8.3. Frequency:-
Daily with each operating
shift.
8.4.Specifications:-
For each grade of controlled
areas or clean rooms limits are given below.
Table: Limits* for Microbial contamination
(cfu/glove) ‡
|
Sr. No.
|
Grade / Class
|
Standard Limit
cfu/glove
|
Alert
Limit
cfu/glove
|
Action
Limit
cfu/glove
|
|
1
|
A
|
<3
|
>1
|
>1
|
|
2
|
B
|
<5
|
>2
|
>3
|
|
3
|
C
|
<25
|
>3
|
>5
|
9. Records
9.1 Aseptic Area Monitoring (SPM & SAS)-
Ampoule and IV Infusion Filling Area
9.2 Aseptic Area Monitoring (SPM & SAS) Vial Filling Area
9.3 Area Monitoring
of Sterility Testing Room
10. Reference:
10.1 Sterile Production,
World Health Organization
10.2 United States
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