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1. SOP for personnel monitoring for
microbial contamination in aseptic
area

2.  Microbiological Personnel monitoring is carried out as per following methods
 1. Finger Dab Method.
 2. Gown swabbing at different places by two methods.
 A. Surface Swab method
 B. Contact Plate Method

3. Finger Dab Method
 Prepare SCDA (Soybean Casein Digest Agar)
medium as per SOP for preparation of culture media.
 Aseptically pour approximately 15 – 20 ml of sterile molten cooled (40°C) SCDA
agar into sterile 90 mm Petri plates.
 Allow solidifying the plates under LAF, after solidification label all the plates with
the name of media, preparation batch No. and date of preparation.
 Invert and incubate the plates for preincubation to check the plates for any
contamination if there is contamination discard the plates as per SOP for
the destruction of microbial waste by Autoclaving.
 Transfer the container in pass box of sterile area and personnel must be entered
through Airlocks (Personnel entry) as per SOP for Entry and gowning procedure for
the sterile area.
 Collect the stainless steel container from pass box of sterile area and disinfect the
container with sterile 70% IPA solution.

4.  Label all the plates with the date of sampling, Personnel and hand name and Shift with the
help of marker pen.
 Call operator or personnel to be monitored, open the plate and tell personnel to place
his/her right-hand fingers with gloves gently on the surface of SCDA plate.
 Use a fresh plate for left-hand finger and follow the same procedure.
 Close the plate and immediately, disinfect the fingers with sterile 70% IPA solution and ask
Operator to go to change room and replace with fresh sterile gloves and gown.
 Prepare a positive control plate by streaking any pure culture of Salmonella / S. aureus / P.
aeruginosa, on the surface of SCDA plate.
 For negative control, incubate the plate as it is without streaking.
 Invert and incubate all the plates at 20 – 25°C for 72 hrs and 30 to 35°C for 48 hours.
 After incubation, count the number of cfu formed on the plates with the help of colony
counter.
 Operate the colony counter as per SOP and record the results per 5 finger

5. Gown Swabbing by Surface Swab Method
 Remove the swab from the tube and rub on the surface to cover approx 25 cm2 area,
uniformly and horizontally in one. 5.2.8 Close the tubes and label with person name, location
name, date. Carry out the same procedure for all locations and analyze the samples without
store a long period.
 Transfer the swab aseptically to MLT lab of microbiology lab through pass box and place all
the sample swabs under LAF.
 Unscrew the tubes and remove the swab stick by gently squeezing and then aseptically streak
into a preincubated SCDA medium plate.
 Label the preincubated SCDA medium Petri plate with person name, Date and location of
swabbing.
 Simultaneously prepare a positive control, by streaking bacterial culture suspension
(Salmonella or S.aureus or P.aeruginosa) into a preincubated SCDA medium Petri plate.
 Invert and incubate all the plates at 20 – 25°C for 72 hrs and 30 to 35°C for 48 hrs
 After incubation, count the number of cfu formed on the plates with the help of colony
counter and record the results cfu per 25 cm2.

6. Gown Swabbing by Contact Plate Method
 Prepare the Contact media plates and pre-incubated the prepared plate as per media
preparation SOP to check the contamination.
 Transfer the contact plates to the aseptic area in an SS container through passbox of the
material entry of sterile area and personnel must be entered through Airlocks (Personnel
entry) as per SOP for Entry and gowning procedure for the sterile area.
 Aseptically open the Contact media plates & gently touch plates for surface sampling at
selected places on the gown.
 Label the contact SCDA medium plate with person name, Date and location.
 Close the plate & keep it in an inverted position.
 Clean the area of Gown by using disinfectant from where the sample is taken.
 Remove the sampled gown to send for washing and autoclaving at provided change room.
Wear another Gown before carrying out the work.
 Invert and incubate all the plates at 20 – 25°C for 72 hrs and 30 to 35°C for 48 hrs. Record
the observations.

7. Precaution
 Result should be expressed as CFU per 25-cm2 in case of swab method.
 Maintain aseptic condition during testing.
 Personnel monitoring shall be done in the airlock.
 After finger dab testing, immediately sanitized the hands with sterile 70% IPA
solution.
 Frequency: Personnel monitoring in the sterile area - Daily after/during
filling.

8. Limits/ Acceptance Criteria Personnel
Monitoring Grade