1. Purpose
Establish A Clean Room cleaning and disinfection procedure to prevent samples from being contaminated by microorganisms in the environment and affecting the accuracy of the test results.
Document number | SOP ZL0014 | File Name | Qc Clean Room Cleaning and Disinfection Procedures |
Preparer | Reviewer | Approver | |
Date of preparation | Year Month Day | Review Date | Approval date: Year Month Day |
Date of publication | Year Month Day | Effective Date | Year Month Day |
Issuing department | Quality Department | Distribution Department | QC Room |
2. Scope
This standard applies to the cleaning and disinfection of QC clean rooms.
3. Responsibilities
QC clean room staff are responsible for the implementation of this standard.
4. Procedures
4.1. Cleaning areas: laminar Clean bench, floor, wall, ceiling, doors and windows, glass, handles, etc.
4.2. Cleaning frequency: before operation, after operation, and the last working day every two weeks.
4.3 Cleaning tools: bucket, mop, mop, sponge, cleaning towel, rubber gloves, etc.
4.4. Cleaning agent: Take Diao brand detergent and add purified water to make a suitable concentration and shake well.
4.5. Disinfectant (rotate monthly)
5% cresol soap solution: Take cresol soap solution and add an appropriate amount of purified water to make a 5% solution and shake well.
0.2% Chlorhexidine solution: Take an appropriate amount of Chlorhexidine and add purified water to make a 0.2% solution, and shake well.
75% alcohol solution: Take 95% ethanol and add purified water to dilute it into a 75% solution, and shake well.
4.6. Cleaning method
①Cleaning and disinfection before operation: Clean or disinfect various surfaces and air in the workroom before operation.
Laminar flow clean bench: After wiping with wet gauze, wipe and disinfect with disinfectant.
Desktop: After wiping with wet gauze, disinfect with disinfectant.
Floor: After wiping with detergent solution, wipe with disinfectant for disinfection.
Air disinfection: After cleaning and disinfecting the clean room, turn on the laminar flow clean bench and start it running. Turn on the laminar flow clean bench UV lamp and the clean room UV lamp for 30 minutes. Turn off the UV lamp before operation.
②Cleaning and disinfection after operation
Tidy up the work surface: Soak the used utensils in the chromic acid cleaning solution for 12 hours and then clean them. Collect various wastes and treat them after disinfection or sterilization.
Wipe the countertop, desktop and floor with detergent and disinfectant respectively.
All discarded live bacterial cultures and vessels containing live bacterial cultures should be sterilized in a steam sterilizer under high pressure. Those that cannot be sterilized under high pressure should be soaked in chromic acid cleaning solution for more than 12 hours, taken out, cleaned and dried for use.
Air disinfection: After the clean room is cleaned and disinfected, turn on the ultraviolet lamps in the clean room and laminar flow clean bench, and irradiate and disinfect for 30 minutes.
③Clean and disinfect after work every two weeks.
First use detergent and disinfectant to wipe various surfaces in the room: laminar flow clean bench, table, countertop, all doors and windows, walls, ceiling, floor, etc.
Turn on the ozone generator for disinfection.
Turn on the ultraviolet lamp for 30-60 minutes.
4.7. Cleaning and storage of cleaning tools: Clean the cleaning tools with detergent, disinfect them with disinfectant, and place them in a designated location to dry for use.
4.8. Evaluation of cleaning effect.
Visual inspection: Various surfaces should be smooth and free of visible foreign matter or dirt.
Test confirmation.
4.9. Procedures for exceeding the specified standards.
If the test results of the laminar flow clean bench exceed the specified standards, use a dust particle counter to find the leakage point of its high-efficiency filter and repair it. If necessary, ask the engineering department to replace the high-efficiency filter or adjust the wind speed.
When other test results exceed the specified standards, the disinfectant should be replaced immediately and tested again after disinfection.