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Tuesday, August 11, 2009

ENVIRONMENTAL MICROBIAL MONITORING OF ASEPTIC AREA IN PHARMACEUTICAL MANUFACTURING BY FINGER DAB TESTING

To check the microbial load on the gloved hands as they come in direct
contact with the product and the machine As the operators frequently disinfect
their gloved hands with 70 % isopropyl alcohol, this method checks the
microbial quality of the gloved hands.

IMPORTANT POINTS/NOTES/PRECAUTIONS:-

1 After the Finger dab testing the gloved fingers are cleaned thoroughly with suitable
disinfactant such as 70 % isopropyl alcohol or the gloves are discarded as they may
contaminate the product or the machine

2 The media used should be asigned a batch no

MATERIAL:-

1 Sterie Soyabean casein digest agar plates


PROCEDURE:-

1 In the aseptic area instruct the persons to place their fingers on the sterile
gently taking care that the media will not break due to pressure

2 Close the plates immediately Put the name of the person on the plate along
with the date

3 Disinfect the gloved hands immediately with 70 % isopropyl alcohol solution

4 Incubate the plates, after solidifying of the medium in bacteriological incubator for 72
hours at 35 deg C to 37 deg C

5 Count the total number of colony forming units (cfu) Calculate the number of cfu/ml
and express in number of cfu/ person

6 If any organisms observed on the plate is recognisable as potential pathogen, investigatate
furthur

7 Positive and negative control is kept along with the test sample

8 Record the observations in the attachment 1



OTHER RELEVANT DETAILS, IF ANY:-

1 Limits:- NMT 3 cfu / person

FREQUENCY OF OPERATION :- As per your requirement.

Standard operating procedure SOP for microbiology and aseptic techniques for manufacturing of sterile dosage forms injections

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