1.0 Purpose :
This SOP provides written guidelines to enumerate the bioload of gloved hands of personnel working in manufacturing area.
2.0 Scope :
This SOP extends to all departments like Tablets, Liquid orals, Dry syrup to enumerate the bio-load by direct contact of the gloved finger tips on sterile Soyabean casein digest agar plate.
3.0 Responsibility :
4.0 Procedure :
4.1 Media used :
4.1.1 Soya bean casein digest agar.
4.1.2 For details of Media composition and preparation refer SOP No.QC/MB/04.
4.1.3 Perform the growth promotion test.
4.2 Preparation of Plates:
4.2.1 Follow the entry procedure of LAF room as per SOP No.xxxx
4.2.2 Switch on the Laminar air flow.
4.2.3 Clean the laminar flow table with 70% v/v IPA.
4.2.4 Cool the sterilized media to about 45°C.
4.2.5 Remove the cotton plug of the sterilized media flask near the flame and hold it along with the flask in the right hand.
4.2.6 Hold the mouth of the flask near the flame slanting taking care the contents do not spill out.
4.2.7 Take out a sterile petriplate using left hand and open the lid slightly near the flame.
4.2.8 Carefully pour about 15 to 20 ml of media to each plate
4.2.9 Close the plate and place it on the laminar bench.
4.2.10 Allow it to solidify.
4.2.11 Repeat the steps 4.2.7 to 4.2.10 till the media gets over.
4.2.12 Mark the plate with media name and its alloted Rehydrated media B.No.
4.2.13 Incubate the SCDA plates at 30° to 35°C for 24 to 48 hours before use.
4.3 Method :
4.3.1 Identify each preincubated SCDA plates with respect to the operators name of whom the test has to be performed.
4.3.2 Carry these plates in a stainless steel bin previously wiped with IPA 70% v/v to the respective department.
4.3.3 Follow the gowning procedure as required by the respective department to
avoid additional contamination.
4.3.4 Disinfect the hands with IPA 70%v/v, wear the sterile surgical gloves.
4.3.5 Towards the end or during filling operation, this test has to be performed.
4.3.6 Remove the lid of the petriplate and take the gloved finger impressions of Operator for at least about 2cms of the fingers of both the gloved hands on the agar surface.
4.3.7 Ensure that the operator changes his gloves before resuming work.
4.3.8 Replace the lids on the respective plates carefully and collect all the plates in the stainless steel bin wiped with 70%v/v IPA & bring it to microbiology department.
4.3.9 Incubate all the S C D A plates inverted at 30° to 35°C in an incubator for 72 hours.
4.3.10 After incubation,observe the counts and report results in the prescribed format (one format copy of each is attached)
Once in a month.
6.0 Limits: Not more than 5 cfu.
Identify the organism based on the high counts and colony morphology by Gram’s staining. In case objectionable organisms found during monitoring (from the dabs of operators) bring to the notice of Q.A to conduct necessary Investigation and training .
7.0 Destruction of the exposed plates:
The exposed plates should be autoclaved in an Autoclave for destruction after the results are taken and then disposed off.