Objective:
To establish a standardized procedure for the entry and exit of personnel into and out of the sterile area in the microbiology lab to maintain sterility and prevent contamination.
To establish a standardized procedure for the entry and exit of personnel into and out of the sterile area in the microbiology lab to maintain sterility and prevent contamination.
Scope:
This procedure is applicable to all personnel entering and exiting the microbiology lab.
This procedure is applicable to all personnel entering and exiting the microbiology lab.
Responsibility:
Microbiologists.
Microbiologists.
Accountability:
Quality Control Manager.
Quality Control Manager.
Procedure:
Entry Procedure:
1. Initial Preparation:
o Remove general production shoes outside the Change Room I of the microbiology lab.
2. Change Room I:
o Enter Change Room I.
o Wear pre-sterilized gloves.
o Sanitize hands thoroughly with the liquid hand sanitizer provided.
3. Change Room II:
o Enter Change Room II.
o Perform the proper gowning procedure as per the SOP:
§ Wear a sterilized over-gown.
§ Wear a sterilized cap.
§ Change into a new pair of sterilized gloves.
o Ensure all gowning is done correctly to maintain sterility.
4. Transfer of Materials:
o Use the pass-through box to transfer sterilized media and glassware to the testing area for microbiological analysis.
Exit Procedure:
1. Testing Area (Sterility Room):
o Remove all used or waste materials and glassware from the laminar airflow cabinet.
o Switch off the laminar airflow cabinet blower and UV-light after 30 minutes.
o Transfer used materials and glassware outside through the pass-through box for cleaning and washing.
2. Moving Through Buffers:
o Exit the testing area and enter Buffer III, ensuring the door is closed properly behind you.
o Proceed to Change Room/Buffer II, remove the gown as per the procedure:
§ Fold the uniform neatly.
§ Place the uniform into a poly bag.
§ Transfer the poly bag outside Change Room/Buffer II for washing and sterilization.
§ Close the door properly.
o Enter Buffer I, closing the door properly behind you.
3. Final Steps:
o Remove lab shoes in Change Room I.
o Exit Change Room I and put on the general shoes designated for use outside the lab.
Precautions:
· Disinfection:
Disinfect the laminar airflow cabinet with 70% IPA and mop it with a lint-free cloth before leaving the testing area.
· Health Restrictions:
Personnel suffering from a cough, cold, or wounds must not enter the microbiological testing area.
· Door Protocol:
Ensure that both doors of the change rooms are never opened simultaneously to prevent contamination.
· Sterilized Equipment:
Always use sterilized over-gowns, caps, and hand gloves when entering the sterile area.This SOP ensures the integrity of the sterile environment in the microbiology lab is maintained and reduces the risk of contamination.
1. Initial Preparation:
o Remove general production shoes outside the Change Room I of the microbiology lab.
2. Change Room I:
o Enter Change Room I.
o Wear pre-sterilized gloves.
o Sanitize hands thoroughly with the liquid hand sanitizer provided.
3. Change Room II:
o Enter Change Room II.
o Perform the proper gowning procedure as per the SOP:
§ Wear a sterilized over-gown.
§ Wear a sterilized cap.
§ Change into a new pair of sterilized gloves.
o Ensure all gowning is done correctly to maintain sterility.
4. Transfer of Materials:
o Use the pass-through box to transfer sterilized media and glassware to the testing area for microbiological analysis.
Exit Procedure:
1. Testing Area (Sterility Room):
o Remove all used or waste materials and glassware from the laminar airflow cabinet.
o Switch off the laminar airflow cabinet blower and UV-light after 30 minutes.
o Transfer used materials and glassware outside through the pass-through box for cleaning and washing.
2. Moving Through Buffers:
o Exit the testing area and enter Buffer III, ensuring the door is closed properly behind you.
o Proceed to Change Room/Buffer II, remove the gown as per the procedure:
§ Fold the uniform neatly.
§ Place the uniform into a poly bag.
§ Transfer the poly bag outside Change Room/Buffer II for washing and sterilization.
§ Close the door properly.
o Enter Buffer I, closing the door properly behind you.
3. Final Steps:
o Remove lab shoes in Change Room I.
o Exit Change Room I and put on the general shoes designated for use outside the lab.
Precautions:
· Disinfection:
Disinfect the laminar airflow cabinet with 70% IPA and mop it with a lint-free cloth before leaving the testing area.
· Health Restrictions:
Personnel suffering from a cough, cold, or wounds must not enter the microbiological testing area.
· Door Protocol:
Ensure that both doors of the change rooms are never opened simultaneously to prevent contamination.
· Sterilized Equipment:
Always use sterilized over-gowns, caps, and hand gloves when entering the sterile area.This SOP ensures the integrity of the sterile environment in the microbiology lab is maintained and reduces the risk of contamination.
END OF THE DOCUMENT
You may like to read these links:
2. List of All SOPs and Documents for In-vitro Laboratory
3. List of All SOPs and Documents for the Animal House Facility
Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.
0 comments:
Post a Comment