Microbial monitoring of personnel’s gloves by using finger dab test

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
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
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.
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
  Alert  Limit
  Action  Limit

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 Pharmacopoeia35.  

11. Distribution:-

This SOP has to be distributed in below mentioned Departments:-

Sr. NO
Distributed to
Quality Control Department

Quality Management Department

12. Revision History:-
Date                                        Changes


No comments:

Post a Comment