SOP for Pesonnel monitoring for microbial contamination of working staff by Gloved Finger Dab Method

Standard Operating Procedure for Pesonnel monitoring for microbial contamination of working staff by Gloved Finger Dab Method

1.0 Purpose:
To lay down a standard operating procedure for gloved finger dab method.

2.0 Scope:
This procedure is applicable for gloved finger dab method in Microbiology laboratory and production area of sterile plant.

SOP for Pesonnel monitoring for microbial contamination by Gloved Finger Dab Method

3.0Responsibility:

Microbiologist / Designee:
•To follow gloves finger dab method as per SOP.

•To perform the sampling and monitoring of gloves finger dab as per frequency.

•To observed the plate as per incubation period.

•To fill the raw data in respective format.

Head/Designee – QC:
•To review, implement and ensure compliance of SOP.

Head/Designee – QA:
•To approve, implement and ensure compliance of SOP.

4.0 Procedure:

4.1 General Procedure:

4.1.1 Prepare soyabean casein digest agar media as per SOP for media preparation.

4.1.2 After sterilization aseptically pour 15-20 ml of pre-sterilized medium at 45ºC into each pre-sterilized petriplates and allow solidifying at room temperature.

4.1.3 Allow the medium to solidify.

4.1.4 Pre-incubate the plates at 30-35ºC for 48 hours.

4.2 Finger Dab Testing:

4.2.1 Carry out the plates in a closed container on sampling location and carefully open the plates prepared as mentioned above.

4.2.2 Press the gloved finger tips of one hand of the analyst gently on the surface of SCDA agar plate and of the other hand another SCDA agar plate. Five finger dabs to be taken on one plate.

4.2.3 Immediately close the petriplate aseptically.

4.2.4 After sampling sanitize the hand with 70% IPA and remove the hand gloved.

4.2.5 Incubate the SCDA agar plate at 20-25°C for 3 days for fungi and 30-35°C for 2 days for bacteria. Simultaneously also place one positive and negative control with test.

4.2.6 Count the number of colony on each plate and recorded the number of colonies as cfu/ gloved in the format.

4.2.7 Gloved finger dabs should be taken in MLT Room or in LAF.

4.2.8 Acceptance Criteria:

4.2.7 Frequency:
Once in a 6 month ±15 days.