Clean laboratory management specifications

1. Purpose

To standardize the cleaning, disinfection and use of clean laboratories, ensure that the testing environment meets the requirements and the experimental data is scientific.

2. Scope of application

Applicable to clean rooms (areas).

3. Responsibilities

3.1 Quality Inspection Department

3.1.1 Formulate this system;

3.1.2 Strictly implement this system.

(Figure 1: Daily management of clean room)

4. Related definitions

Clean room (area): a room or area where dust particles and microorganisms in the environment need to be controlled.

5. Work procedures

5.1 Cleaning and disinfection

5.1.1 Cleaning and disinfection cycle and cleaning and disinfection scope

5.1.1.1 Cleaning scope before and after each work.

Clean the operating room and irradiate it with ultraviolet light for 30 minutes. 0 Use a mercerized towel soaked in disinfectant to squeeze and wipe the outer surface of the instrument placed on the workbench, then wipe the surface of the workbench (from top to bottom), and wipe the stools and floors in the clean area (including the intermediate floor) after the operation.

5.1.1.2 Weekly cleaning scope

In addition to 5.1.1.1, wipe all walls and doors in the clean area, and then wipe the hooks and the floor of the locker room.

5.1.1.3 Monthly cleaning scope

5.1.1.4 External ceiling wipe

5.1.2 Preparation and use of disinfectants

5.1.2.1 0.1% Sanisol solution: Take 40 ml of 5% Sanisol solution, add water to 2000 ml, and shake well. Used for disinfection of hands, instruments, surfaces of utensils, floors, and walls.

5.1.2.2 75% ethanol solution Take 1579 ml of 95% ethanol and add water to 2000 ml. Used for disinfection of instruments, surfaces of utensils, floors, walls, and hands

5.1.2.3 Disinfectants are rotated once a month.

(Figure 2: Clean room cleaning)

5.1.3 Disinfection methods and cycles of operating rooms

5.1.3.1 Before each use or when individual sedimentation bacteria exceed the standard, ultraviolet rays can be used for 30 minutes. 

5.1.3.2 Formaldehyde fumigation shall be applied every six months or when sedimentation bacteria are seriously unqualified. Method: Calculate the volume of the required disinfection space, use 10ml of 35-38% formaldehyde solution and 2g of potassium permanganate per cubic meter. Take an appropriate amount of potassium permanganate, dissolve it in hot water at about 60℃, pour it into a certain amount of formaldehyde solution, cover the cup with a layer of gauze, and the personnel shall immediately walk out of the clean area, close all doors and windows, and simmer for 16 hours, close the fresh air inlet, and start the air conditioning cycle for more than 2 hours to disinfect the air conditioner. After feeling no odor, the personnel shall enter the clean area and wipe all surfaces (including the ground) with 75% alcohol.

5.1.3.3 If the sedimentation bacteria are poor during normal use, 0.33~1mol/L lactic acid (1.5ml/m3) can also be sprayed, re-steamed and sealed for more than 12 hours, and then exhausted.

5.2 Entry and exit of personnel

5.2.1 Personnel who are not related to the work or unauthorized are not allowed to enter the clean area at will. A maximum of 2 people can enter the sterile room. Personnel entering the clean area are not allowed to use cosmetics on their exposed faces, wear ornaments, or have long nails.

5.2.2 Anyone with a cold, hay fever, or rash is not allowed to enter the room

5.2.3 The room must be cleaned and disinfected before operation, and the Clean bench and other purification systems must be turned on at least 30 minutes in advance. If necessary, the air conditioner can be turned on (temperature 18~26℃, Relative humidity 30~70%).

5.2.4 Steps for operators to enter the clean room:

Shoe change: Take off shoes and put them in the corresponding shoe cabinet;

Changing clothes: Open the corresponding locker in the first shift, hang the changed clothes in the locker, then enter the second shift and put on the clean clothes neatly.

Wash hands: Turn on the faucet, wet both hands to the wrists with tap water, then squeeze hand sanitizer on the hands and rub them together for 10 seconds. The cleaning range should include the hands, back of the hands and wrists. Finally, rinse the foam with tap water to make the hands rub without greasy, then dry them under the dryer, then put on sterile gloves and enter the clean laboratory.

Disinfection: Disinfect your hands with disinfectant before you can put your hands into the ultra-clean workbench to work.

5.2.5 Wipe the surface of the operating table and utensils with a mercerized towel soaked in disinfectant, and then operate according to regulations.

5.2.6 After the work is completed, put the alcohol lamp on the cover (do not blow with your mouth), move all items to the transfer window, and clean according to the clean area cleaning and disinfection. The operator exits the operating room in the reverse order of entering. Take out the clean clothes that have been changed and the clean clothes that need to be cleaned and sterilized. Then take off the gloves.

(Figure 3: Clean room personnel entering and exiting)

5.3 Entry and exit of materials

5.3.1 Items must Enter the clean room through the transfer window, and items must not be brought into the clean room through the flow channel.

5.3.2 Use of the transfer window

5.3.2.1 Transfer from the non-clean area to the clean area.

Open the door on the side of the non-clean area and put the items to be transferred into the transfer window.

Close the transfer window door, turn on the ultraviolet light for at least 15 minutes and then turn it off.

Open the door on the side of the clean area, take out the items to be transferred, and close the door.

5.3.2.2 Transfer from the clean area to the non-clean area

Open the door on the side of the clean area and put the items to be transferred into the transfer window.

Close the transfer window door, open the door on the side of the non-clean area, take out the items to be transferred, and close the door.

5.3.3 After each use of the transfer window, wipe the transfer window with disinfection wave, and no residue should be left to prevent contamination of other items.

5.3.4 When the test sample enters the clean room, wipe the outer surface with disinfection wave, and it is forbidden to turn on ultraviolet irradiation. The test sample must be delivered to the clean room separately from other items.

(Figure 4: Clean room material in and out)

5.4. Precautions

5.4.1 Operators who enter the operation room are not allowed to go out to get items, so the items used in each test must be planned and spare items must be prepared, but no irrelevant items should be stored.

5.4.2 When operating in the operation room, the alcohol lamp must be lit so that the operation is carried out next to the flame of the alcohol lamp. Each time the solution is added or absorbed, the mouth of the container should pass through the outer flame of the alcohol lamp.

5.4.3 Regularly test the sedimentation bacteria and dust particles in the sterile room.

5.4.4 After each scrubbing, the rag should be cleaned with laundry soap and tap water, and soaked in disinfectant for 30 minutes.

5.4.5 All items entering the sterile room should be properly disinfected or sterilized as required before being introduced into the sterile room.