Entry and Exit procedure for Microbiology section

This article describes about (Standard Operating procedure) SOP on Entry and Exit procedure for microbiology section in Pharmaceutical Industry.

SOP on Entry and Exit procedure for Microbiology section

I. Purpose & Scope:

• To provide a general methodology to be followed while  Entry and Exit procedure for Microbiology section
• Applicable to all personnel who are working in Microbiology, Quality control and quality Assurance Department

II. Responsibilities:

• All Microbiology, Quality control and quality Assurance personnel shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part :

PROCEDURE:

ENTRY PROCEDURE FOR MICROBIOLOGY SECTION:

• Entry to the Microbiology section shall be strictly restricted. Only authorized personnel are allowed. Refer annexure-I for list of authorized personnel in Microbiology section.
• Enter in to QC passage through QC entrance.
• Employees and Visitors shall follow the procedure as given below.

Entry procedure for Employee:

• Push the door of Microbiology laboratory and enter into Microbiology change room.
• Remove the personal footwear; keep them into cross over bench and then cross over the bench.
• Sanitize the hands with disinfectant and wear clean dedicated apron/ lab coat. Wear clean dedicated head cap.
• Wear nose mask and dedicated foot wear for microbiology laboratory.
• Sanitize the hands with disinfectant.
• Open the door and enter into Microbiology section.

Entry procedure For Visitors and other authorized persons:

• Push the door of Microbiology laboratory and enter into Microbiology change room.
• Wear shoe covers and cross over the bench.
• Sanitize the hands with disinfectant and wear clean dedicated apron/ lab coat. Wear clean dedicated head cap.
• Wear nose mask and sanitize the hands with 70% IPA.
• Open door and enter into Microbiology section.

EXIT PROCEDURE FOR MICROBIOLOGY SECTION :

Exit Procedure for Employee:

• Open the door of Microbiology change room and enter into the change room.
• Sanitize the hands with disinfectant.
• Remove the dedicated apron/ lab coat and head cap, keep it onto the hanger. Remove foot wears of Microbiology laboratory and keep them into cross over bench.
• Cross over the bench.
• Remove nose mask and discard it into the waste bin.
• Wear the personal foot wear. Sanitize the hands with disinfectant.
• Open the door and exit from the Microbiology laboratory.

Exit Procedure for Visitors and other authorized persons:

• Open the door of Microbiology change room and enter into the change room.
• Sanitize the hands with disinfectant.
• Cross over the bench.
• Remove the apron/ lab coat, shoe covers and nose mask. Discard it into the waste bin. Sanitize the hands with disinfectant.
• Open the door and exit from Microbiology laboratory.

ENTRY PROCEDURE FOR MICROBIOLOGY TESTING ROOM / BET ROOM:

• Open the door of Airlock-I and enter into Airlock-I.
• Remove the footwears; keep them into cross over the bench.
• Open the door of Airlock-II and enter into Airlock-II by cross over the bench.
• Wear the dedicated foot wears.
• Remove the apron and head cap. Keep it on the hanger.
• Wear clean dedicated head mask, garment and sterile hand gloves.
• Open the door and enter into Airlock-III. Sanitize the hands with disinfectant.
• Open the door and enter into Microbiology Testing Room.
• For entry into BET room. Push the door and enter into BET room.

EXIT PROCEDURE FOR MICROBIOLOGY TESTING ROOM / BET ROOM:

• After completion of work, exit from the BET room and enter into Microbiology Testing room.
• Push the door and exit into Airlock-III. Sanitize the hands with disinfectant.
• Pull the door and exit into Airlock-II.
• Remove hand gloves and discard into waste bin.
• Remove garment and head mask, keep it into dedicated bin. Wear the apron and cap.
• Open the door of Airlock-I. Remove foot wears and cross over the bench. Enter into Airlock-I.
• Wear laboratory footwear and exit from Airlock-I.

PRECAUTIONS:

• Entry to Microbiology section shall be restricted.
• Airlock pressure, Temperature of the Microbiological testing room and BET room should be within limit.
• Ensure that doors of adjacent area are closed completely before opening the next door.
• Ensure cleanliness of garments and laboratory footwears.
• While wearing and removing the footwears, avoid touching them by hands.

ANNEXURE:

Annexure I: Reference format for List of Authorized Persons

Annexure I

                                                                          LIST OF AUTHORISED PERSONS

Note: Visitors or any other employee of Company must be accompanied by at least one of above mentioned Personnel.