Clean laboratory management specifications

Clean Laboratory Management Specifications

Standardizing cleaning, disinfection, and usage protocols to ensure testing environment compliance and scientific data integrity

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.

Scope of Application

Applicable to clean rooms (areas).

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

CleanRoom Validation Testing for Medical Devices

Related Definitions

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

Work Procedures

5.1 Cleaning and Disinfection

5.1.1 Cleaning and Disinfection Cycle and 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. 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

External ceiling wipe

5.1.2 Preparation and Use of Disinfectants

Solution	Preparation	Usage
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.
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.

Note: Disinfectants are rotated once a month.

Figure 2: Clean room cleaning

5.1.3 Disinfection Methods and Cycles of Operating Rooms

UV Disinfection

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

Formaldehyde Fumigation

Applied every six months or when sedimentation bacteria are seriously unqualified. Use 10ml of 35-38% formaldehyde solution and 2g of potassium permanganate per cubic meter. Simmer for 16 hours.

Lactic Acid Treatment

If sedimentation bacteria are poor during normal use, spray 0.33~1mol/L lactic acid (1.5ml/m³), re-steam and seal for more than 12 hours.

5.2 Entry and Exit of Personnel

Access Restrictions

Personnel not related to the work or unauthorized are not allowed to enter the clean area.
A maximum of 2 people can enter the sterile room.
No cosmetics, ornaments, or long nails permitted.
Anyone with a cold, hay fever, or rash is not allowed to enter.

Preparation Protocol

Room must be cleaned and disinfected before operation
Clean bench and purification systems must be turned on at least 30 minutes in advance
Maintain temperature (18~26°C) and Relative humidity (30~70%)

5.2.4 Steps for Entering the Clean Room

Shoe Change

Take off shoes and put them in the corresponding shoe cabinet

Changing Clothes

Put on clean clothes in the changing room

Hand Washing

Thorough washing and drying of hands

Disinfection

Disinfect hands before entering work area

Figure 3: Clean room personnel entering and exiting

5.3 Entry and Exit of Materials

5.3.1 Transfer Requirements

Items must Enter the clean room through the transfer window
Items must not be brought in through the flow channel

5.3.2.1 Transfer from Non-clean to Clean Area

Open non-clean area door and place items in transfer window
Close window and turn on UV light for ≥15 minutes
Open clean area door and remove items

5.3.2.2 Transfer from Clean to Non-clean Area

Open clean area door and place items in transfer window
Close window and open non-clean area door
Remove items and close door

Figure 4: Clean room material in and out

5.4 Precautions

Operators cannot leave to retrieve items once work begins
All required items must be planned and prepared in advance
Alcohol lamp must be lit during operations
Regular testing of sedimentation bacteria and dust particles
Proper cleaning and disinfection of cleaning tools
All items entering sterile room must be properly disinfected

Laboratory Cleanliness Standards

Maintaining a controlled environment through strict protocols ensures the integrity of experimental data and compliance with industry standards. Consistent adherence to these procedures is essential for scientific validity.