Personnel Monitoring or personnel Qualification

Personnel monitoring is very critical in aseptic area. Personnels are main source of the contamination in aseptic area.

Personnel monitoring done contact plate method (RODAC Plate).

For personnel monitoring 55mm contact plates are used but for fingger dab monitoring 90 mm SCDA plates can be used because 55mm plates are small to cover five fingger dabs properly on single plate.

Personal Monitoring shall be done at the end of each shift during all the critical operations using RODAC plates.

Personnel after being monitored will exit the aseptic area.

Personnel monitoring to be performed in the Corridor / Buffer room.

Personnel monitoring shall be done for all the persons involved in Vial Filling & sealing activity(critical activity).

Incubate the samples at 20-25⁰C for 72 hrs & 30-35^oC for 48 hrs.

Before involved in the critical operation (filling and sealing activity) personnel qualification is required.

Personnel qualification done 3 consecutive days.

Personal monitoring Locations

1.    Fore head

2.    Chest

3.    R Armfit

4.    L Armfit

5.    R. Elbow

6.    L.Elbow

7.    Right hand gloves