SOP for Environmental Monitoring of Aspetic Area: Finger Prints and Gown Sampling : Pharmaceutical Guidelines

SOP for Environmental Monitoring of Aspetic Area: Finger Prints and Gown Sampling

Standard operating procedure to ensure the control over microbial contamination on personnel working in aseptic area.

1.0 Objective

To ensure the control over microbial contamination on personnel working in the aseptic area.

2.0 Scope

This procedure is applicable to check the personal hygiene by means of Fingerprint and Gown swab sampling for the persons working in the aseptic area.

3.0 Responsibility

3.1 Doing: Technical Assistant(Microbiologist)/Executive.
3.2 Checking: Executive/Manager

4.0 Accountability

Head of the Department

5.0 Procedure

5.1 Frequency of sampling

Location
Frequency
Person working in preparation and filling room.
Once in a week
Person  working in green area
Once in a Month

5.2 Media Preparation:

5.2.1 For Fingerprint: Sterile Soybean Casein Digest agar plate
Pour about 20ml of sterile Soybean Casein Digest Agar Medium in each pre-sterilized and dried plate (90 mm size) under Laminar airflow bench and allow it to solidify.
5.2.2 After solidification of Medium, place the SCDA Petri-plates at 30°C-35°C in the inverted position in S.S. trays and incubate for 48hrs.
5.2.3 After incubation period observe the plates for contamination.
5.2.4 Discard contaminated plates if any found as per S.O.P.
5.2.5 For Gowning:- Prepare Sterile RODAC Plate as per S.O.P.

5.3 Fingerprint:

5.3.1 Take the prints of fingertips from both gloves on two different Soybean Casein Digest agar plate.
5.3.2 Mark the plate with left and the right hand, name of the person, working area, and date.
5.3.3 Instruct the person to change the gloves immediately and discard the old pair of gloves in S.S. Bowl containing 70% filtered IPA.
5.3.4 After sampling, incubate the plates at 30-35°C for 72hrs and then record the results in Annexure.

5.4 Limit: For fingerprint :

Results: CFU per gloves.

                   Location

Alert Level

Action Level
Person  Working in preparation and filling rooms.
2-3
>3
Person  Working in Green area
5-10
          >10

5.4.1 Acceptance criteria:

The bacterial colony should be within limit & fungi should be Absent.

5.5 Gown Swab:
5.5.1 Contact RODAC plates on the gown from the lower part of both sleeves, chest and the front of the collar.
5.5.2 Take the sampling when the person is on way out to the working area, towards the recess, end of the shift.
5.5.3 Instruct person to discard that gown immediately after sampling and send for washing/cleaning and sterilization.
5.5.4 After sampling incubate the plates at 30-35°C for 72 hrs and then record the results.
5.6 In case of result exceeding the Action level limit, inform the head of the department, Production head and Q.A. head for necessary action.
5.5.6 Limit: Results: CFU per agar plate.1 plate per sampling site.

Location
Alert Level
Action Level
Person Working in preparation and filling
3-5
>5
Person Working in Green  area
5-10
>10

5.5.7 Acceptance criteria:

Bacterial colony should be within limit & fungi should be Absent

6.0 ABBREVIATION

°C = Degree centigrade
hrs = hours
S.O.P .= Standard Operating Procedure
IPA = Isopropyl alcohol
SCDA = Soybean Casein Digest Agar

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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