๐ฃ๐ฒ๐ฟ๐๐ผ๐ป๐ฒ๐น ๐บ๐ผ๐ป๐ถ๐๐ผ๐ฟ๐ถ๐ป๐ด ๐ถ๐ป ๐ฝ๐ฟ๐ผ๐ฑ๐๐ฐ๐๐ถ๐ผ๐ป ๐ฎ๐ฟ๐ฒ๐ฎ. ๐ฃ๐ฒ๐ฟ๐๐ผ๐ป๐ป๐ฒ๐น ๐บ๐ผ๐ป๐ถ๐๐ผ๐ฟ๐ถ๐ป๐ด ๐ถ๐ป ๐ฝ๐ผ๐๐ฑ๐ฒ๐ฟ ๐ฝ๐ฟ๐ผ๐ฐ๐ฒ๐๐๐ถ๐ป๐ด ๐ฎ๐ฟ๐ฒ๐ฎ. ๐ฃ๐ฒ๐ฟ๐๐ผ๐ป๐ป๐ฒ๐น ๐ต๐๐ด๐ถ๐ฒ๐ป๐ฒ ๐ฝ๐ฟ๐ฎ๐ฐ๐๐ถ๐ฐ๐ฒ๐ ๐ถ๐ป ๐บ๐ฎ๐ป๐๐ณ๐ฎ๐ฐ๐๐๐ฟ๐ถ๐ป๐ด ๐ฎ๐ฟ๐ฒ๐ฎ.
OBJECTIVE:
To establish the procedure for monitoring the Personnel from the Production area for their personal hygiene practices.
SCOPE:
Personnel from the production areas are monitored
RESPONSIBILITY:
Microbiologist Quality Control
To perform Personnel monitoring as per SOP.
Head/Designee Production
To provide the necessary support to carry out the activity.
Head/Designee Quality Control
To ensure that SOP is followed as written
Head/Designee Quality Assurance
To ensure data compilation and review.
ACCOUNTABILITY:
Head/Designee Quality Control
Head/Designee Quality Assurance
PROCEDURE:
Personnel from the Production area are monitored to ensure that personnel hygiene practices are followed.
Preparation of Contact Plates
The microbiologist prepares the plates by aseptically dispensing about 20 ml each of sterile melted MSA and MAC into sterile, empty contact plates of 50cm² area.
After the agar solidifies, the plates are inverted and incubated at ambient temperature for 24 hrs. This is done in order to confirm the sterility of the plates. Contaminated plates are discarded and not used.
Mark the contact plate with Initials of the person and date.
Expose one plate at a time for all 5 fingers of one hand each. The MSA plate is used for the Right hand imprint and the MAC plate is used for the left hand imprint.
After obtaining the finger print impression of the fingers, close the plate, bring the plate to Microbiology Laboratory and incubate at 30ยบC to 35°C for 48 hrs.
Personnel hygiene
The nails of the personnel are checked simultaneously. Every person working in production should have a bath daily. Every person should have a clean shave. Hair should be cut short. Employees suffering from major illness or having open injuries should not enter the production area.
Evaluation of results:
Observe the colonies / plate on each Hand and report as Negative (-) . if typical colonies of Staphylococcus aureus on MSA and Escherichia coli on MAC are absent.
In case of typical colonies being observed, report to Production / QA Managers for corrective action. Incase the number of colonies observed are >300cfu/plate, also request for corrective action.
Corrective Action
Manager Production along with Manager Quality Assurance provides retraining on personnel hygiene practices.
RECORDS:
Personnel Monitoring Format
FREQUENCY:
Twice in a year
REFERENCES:
Good Manufacturing Practices
DISTRIBUTION:
Microbiology Laboratory
GLOSSARY & ABBREVATIONS:
SOP : Standard Operating Procedure
MAC : Mac Conkeys Agar
MSA: Manitol Salt Agar
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