Microbial monitoring of personnel’s clothing by using contact plate


Microbial monitoring of personnel’s clothing by using contact plate
1.     Purpose:-                         

To evaluate the microbial status of personnel’s clothes by using contact plates..
2.     Scope:-

                 It is applied to clothing of all the operators/personnel participating in aseptic products filling
                 in Liquid Injectables and IV Infusion of Production Department
                 and also to personnel working in Sterility Testing Suit
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.
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 & 50mm)
   6. Definitions:-

   6.1 Contact plates: These plates are commonly known as RODAC (Replicating and dividing air counts)
         contact plates. This type of plate is used for sampling on hard surfaces and personnel’s uniform
         monitoring. A contact plate is an agar plate, with a raised surface, applied to a surface for the
      enumeration of microorganisms). It stands for Replicate Organism Detection and Counting.
      In addition, finger dab test can be used to evaluate operator training.
7.Flow Chart:-



8. Description:-
8.1 Procedure:-             
8.1.1 Preparation of Media:-
8.1.1.1 Weigh desired amount of agar medium (e.g.; Nutrient agar or TSA) in a screw cap flask.
8.1.1.2 Dissolve agar medium in calculated volume of distilled water according to manufacturer’s
            instruction and boil to dissolve completely.
8.1.1.3  Tight the cap of the flask and autoclave the medium at 1210C for 15min.
8.1.1.4  Take clean and washed Petri plates (50mm and 90mm) and place 50mm plate in 90mm petriplate in the way that upward position of 50mm plate must face the lid side of 90mm plate.
8.1.1.5  Sterilize the Petri plates in hot air oven at 2000C for 2 hours.
8.1.1.6  Allow Petri plates to cool at room temperature.
8.1.1.7  Pour molten and autoclaved agar medium cooled at 400C in 50mm sterile Petri plates at its maximum surface by lifting the lid of 90mm petriplate. Agar Medium should be poured under LFH.
8.1.1.8  Allow agar medium to solidify.
8.1.1.9  After solidification, incubate each petriplate in inverted position for 48 hours at 32.5+2.50C.
8.1.1.10    Examine each petriplate for contamination after incubation. Contaminated Petri plates should be disposed off.
8.1.1.11 Use only sterile Petri plates for sampling.
8.1.12 Mop each petriplate from outside with a clean duster dipped in 70% IPA and label according to sampling plan.
8.1.1.13 Place all the Petri plates in a SS-tray properly mopped with 70% IPA and transport it place of test.
8.1.1.14 During transportation, do not open the lid of SS-tray.
8.1.1.15 Place the SS-tray in Pass Through under UV Light for 30 minutes.




8.1.2 Monitoring of Personnel Clothing    
8.1.2.1 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 clothes or uniforms are dry
            and free of any disinfectant.
8.1.2.2 The operator should lift the lid of the plate and bring 50mm plate out of 90mm plate  and touch
            the agar surface to the uniform at different locations.
8.1.2.2 A firm and even pressure should be applied for approximately 5 to 10 seconds at each location by
           taking care not to damage the agar surface.
8.1.2.3  Label the plate with date, site, area and name of the operator.
8.1.2.4  In testing the uniform following sites can be tested; sleeves, hood, mask, shoulders and backside.
8.1.2.5  Aseptic handling is required during test. No any other surface should touch with agar surface except the clothing or uniform of operator.
8.1.2.6  Wipe the area tested with disinfectant.
8.1.2.7  Incubate an unexposed plate to serve as control.
8.1.2.8  After that take the SS-tray to microbiological area, incubate the plates for 48 -72  hours at 32.5+2.50C and record the results.
8.2        Frequency:-
Weekly
8.3 Specifications:-
           For each grade of controlled areas or clean rooms limits are given below.      








Table: Limits* for Microbial contamination (cfu/plate 55mm diameter)
Sr. No.
Grade / Class
Standard  Limit
     cfu/plate 55mm diameter
  Alert  Limit
cfu/plate 55mm diameter
  Action  Limit
     cfu/plate 55mm diameter
1
A
<3
>1
>1
2
B
            <5
>2
>3
3
C
            <25
>10
>15

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
Received
(Current)
Returned
(Obsolete)
1
Quality Control Department


2
Quality Management Department


 
12. Revision History:-
         
Date                                        Changes

N/A


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