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Cleanroom Management Specification Version 3

  • Author:Jason Peng

  • Cleanroom Engineering Technology Manager of Deiiang Company.

    Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

    Executive Director of Guangdong Cleanroom Industry Association of China.

    Engaged in R&D of related products for 15 years, with rich relevant technical experience

  • 2024-11-27  |  Visits:


1. Qualifications for entering the clean room

1.1 Only personnel who have passed the training and have been reviewed by the supervisor can Enter the clean room.

1.2 Personnel entering the clean room must comply with the safety regulations of the clean room.

GMP Cleanroom Requirements for Safe and Effective Workflow - Angstrom  Technology

(Figure 1: Qualifications for entering A Clean Room)

1.3 Employees and external guests who have not yet been approved and need to enter the clean room should first notify the production department or be accompanied by business department personnel and production department managers before entering.

1.4 Unauthorized personnel are strictly prohibited from entering the clean room.


2. Things to note before entering the clean room

2.1 Employees and external guests must be accompanied by relevant personnel when entering and leaving the clean room.

2.2 Anyone who enters the clean room for work or visit must change into clean clothes according to regulations.

2.3 Personal belongings (handbags, books, snacks, etc.) and tools not used in the clean room are not allowed to be brought into the clean room; maintenance manuals and tools should be returned immediately after use.

Cleanroom Gowning and Entry Procedure - Angstrom Technology

(Figure 2: Things to note before entering a clean room)

2.4 When materials enter the clean room workshop, they must be unpacked and wiped outside first, and then placed in the cargo air shower and brought into the clean room workshop.

2.5 In the clean room workshop, it is not allowed to eat, drink, play or engage in other things unrelated to production.


3. Procedure for entering the clean room

3.1 When stepping on the floor at the entrance of the shoe changing area, you must take off your outer shoes.

3.2 Place outer shoes in a general shoe cabinet; enter the locker room to change into clean clothes, and then enter the air shower and enter the workshop according to regulations.

3.3 No more than 4 people can enter the air shower room at the same time. The limit for entering the clean room is 2 people, and the limit for leaving the clean room is 4 people.

3.4 In order to avoid affecting the normal air circulation and dust removal effect, personnel must not lean on the door or wall of the air shower; personnel must stand on the sticky mat in the center of the air shower and gently shake their hands to rotate 360 degrees to help dust fall off.

HTL

(Figure 3: Air Shower)

3.5 The normal direction of the nozzle should be downward. Please do not fiddle with the adjusted nozzle direction at will to achieve the maximum dust removal effect.

3.6 The hair must be covered in the dust-free cap. A hair cover can be used when necessary.

3.7 The mouth and nose must be covered in the mask. The mask should be discarded after use and cannot be reused. The hair must be tucked into the dust-free clothing.

3.8 Procedure for wearing dust-free clothing:

  • Mask

  • Dust-free clothing

  • Dust-free shoes

Put on the dust-free clothing, put on the mask and dust-free cap, zip up the dust-free clothing, put on dust-free shoes, and make sure that the clothes are neat before entering the Dust-free workshop.


4. Things to note in the dust-free room

4.1 Paint or items entering the dust-free room must first be air-cleaned and dust-removed.

4.2 It is strictly forbidden to write or scratch on the equipment.

4.3 Avoid using tape to stick paper on the machine.

4.4 When using an air gun, it must be placed at the dust removal outlet to prevent dust from contaminating the product.

Laboratory Waste Guide 2024

(Figure 4: Cleanroom waste disposal)


5. Waste disposal

5.1 All waste and used chemicals should be disposed and dumped in accordance with the prescribed methods.

5.2 Keep clean at all times, do not leave garbage to others, gloves, finger cots, and waste should not be thrown away casually, they should be placed in the garbage.

5.3 Do not mix acids and organic solvents to avoid explosion.

5.4 Organic waste solvents should be stored in special containers and not poured into the drainage system.


6. Other precautions

6.1 Do not walk back and forth in the dust-free room.

6.2 Non-essential related personnel are prohibited from staying in the dust-free area.

Cleanroom Environmental Monitoring | Vaisala

(Figure 5: Cleanroom monitoring)


7. Equipment use rules

7.1 All equipment should be turned on, off, and debugged according to the steps specified in the operation manual, and must be turned on by the person in charge on duty.

7.2 If the person in charge of the startup encounters a fault or uncertain factors that affect the startup or debugging, he should report to the leader and wait for instructions before handling it.

7.3 The settings of the clean room coating equipment shall not be changed without the approval of the on-duty leader.

7.4 Please record the use of the equipment and the temperature and humidity in the clean room and spray room during use.

7.5 Any pollution or damage caused by improper operation of the equipment should be reported as soon as possible and punished. If there is deliberate concealment, the punishment will be increased once it is discovered.

7.6 Spray guns and spraying equipment should be cleaned according to regulations after use.

5 Safety Hazards in Cleanrooms – Medco

(Figure 6: Cleanroom Safety Management)


8. Clean room safety rules

8.1 When working in a clean room, you must accurately understand the possible dangers at each workstation and the safety protection measures that should be taken.

8.2 Make good use of some protective equipment such as glasses, gloves, etc.

8.3 The work area should be kept clean.

8.4 All chemicals should be labeled in detail.

8.5 After using chemicals, hands must be washed before eating.

8.6 When handling waste, the relevant waste disposal regulations should be followed.

8.7 Be familiar with the emergency response steps and the location of emergency response equipment (such as fire extinguishers, emergency lights, etc.) in the work area.

8.8 All fire sources are strictly prohibited from being brought into the dust-free workshop.

News - BASIC PRINCIPLES IN FIRE PROTECTION DESIGN OF CLEAN ROOM BUILDINGS

(Figure 7: Cleanroom fire protection)


9. Clean room workshop system penalties

9.1 Anyone who violates the above regulations and causes economic losses to the company will be given administrative warnings, demerits or dismissals according to the losses.

9.2 Mobile phones used by personnel entering the clean room should be stored in the closet or brought into the clean room in a closed state. If anyone is found using a mobile phone in the clean room, he will be punished with demerits, dismissal, etc.

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