STANDARD OPERATING PROCEDURE Personnel Monitoring Procedure for Microbial Contamination in Manufacturing area by Finger Dab Test

	STANDARD OPERATING PROCEDURE
	Department: Quality Control	SOP No.: QC/MB/
Personnel Monitoring Procedure for Microbial Contamination in Manufacturing area by Finger Dab Test		Effective Date:
		Review Date:
		Page No.:

1.0            OBJECTIVE:

1.1                   To lay down a procedure to enumerate the bio-load (Total Microbial Count) of gloved hands of personnel working in manufacturing area by finger dab test.

2.0            SCOPE:

2.1                   This procedure is applicable to microbial monitoring of personnel working in production areas like dispensing, granulation, compression, coating, capsule filling, bottle and blister packing at Pharma Private Limited.

3.0            RESPONSIBILITY:

3.1                   Microbiologist: Responsible for carryout the activity.

3.2                   Section In-charge: Responsible for review the procedure and results.

3.3                   QC Head: Responsible for implementing the Procedure.

3.4                   QA Head: Overall compliance.     

4.0            PROCEDURE:

4.1                 Media Plates Preparation:

4.1.1             Prepare SCDA plates as per current version of SOP (Preparation and Sterilization of Microbial Media) QC/MB/ and pre-incubate the prepared SCDA plates at 30°C to 35°C for 24 to 48 hours.

4.1.2             After completion of incubation period observe the plates, if any contamination observed discard the contaminated plates.

4.1.3             Use sterile and pre-incubated agar media plates for personnel monitoring.

4.2                 Personnel Monitoring Procedure:

4.2.1             Carry these plates in a stainless steel bin previously wiped with IPA 70% v/v to the respective department.

4.2.2             Follow the gowning procedure as required by the respective department to avoid additional contamination.

4.2.3             Where ever required disinfect the hands as per method mentioned in annexure – I (Disinfecting Hand Rub Technique).

4.2.4             Identify each pre-incubated SCDA plates with respect to the operator’s name of whom the test has to be performed and date of testing.

4.2.5             This test has to be performed at the end of shift or during operation.

4.2.6             Disinfect the hands with IPA 70%v/v, wear the sterile surgical gloves.

4.2.7             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 (use separate SCDA media plates for left and right hands).

4.2.8             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 for incubation.

4.2.9             After finger dabbing, ensure that the operator changed his gloves before resuming work.

4.2.10         Enter the details of test like name of the person, area of working, date of testing in Annexure-II (Personnel monitoring inward record).

4.2.11         Incubate SCDA plates at 30°C to 35°C for 48 hrs in bacteriological incubator and then transfer to BOD incubator and incubate at 20°C to 25°C for 72 hrs.

4.2.12         Incubate a negative control plate which is not tested.

4.2.13         After incubation period, count the colony forming units with the help of colony counter and report the results in Annexure – III (Test report of personnel monitoring).

4.2.14         Acceptance Criteria: Not more than 100 cfu/glove.

4.2.15         Frequency: Quarterly ±7 days.

5.0            ABBREVIATIONS:

QC: Quality Control	QA: Quality Assurance
SOP: Standard Operating Procedure	IPA    :  Isopropyl alcohol.
cfu: Colony Forming Unit	BOD: Biological Oxygen Demand
SCDA: Soyabean Casein Digest Agar	%: Percentage
v/v: Volume/Volume	WHO: World Health Organization