+86 18186671616
Jason@cleanroomequips.com
1. Purpose
To ensure the environmental quality of the clean room and reduce the company's management costs, ensure product quality and improve operating efficiency.
2. Scope
All personnel (including our company's personnel, manufacturers and visiting guests, etc.) and materials and supplies entering the clean room are subject to the constraints and specifications of this management regulation.
(Figure 1: Dust-free workshop management)
3. Responsibilities
3.1 Biotechnology Department: Responsible for supervising all personnel entering the clean room to abide by the rules;
3.2 Marketing Department: Responsible for explaining the relevant regulations for entering the clean room to customers who need to enter the clean room and requiring cooperation.
4. Management content
4.1 Management of entering the clean room
4.1.1 Before entering the clean room, our company's personnel must change their shoes into indoor slippers (or put on shoe covers) in the shoe changing area, and personal belongings (handbags, books, etc.) must be left outdoors and must not be placed in the clean room.
4.1.2 If vendors or guests wish to enter the cleanroom to perform work or visit, they must be accompanied and guided by relevant personnel of the company; vendors or guests who wish to enter the cleanroom must change their shoes into indoor slippers (or put on shoe covers) in the shoe changing area in accordance with regulations, and personal belongings (handbags, books, etc.) must be left outside and must not be brought into the cleanroom.
4.1.3 The following persons are not allowed to enter the cleanroom:
Non-operating personnel or those without prior permission;
Those who have not changed into special slippers or shoe covers;
Those who have just finished intense exercise and are sweating;
Those who wear makeup and lipstick.
4.1.4 Tools, materials and accessories that are to be brought into the cleanroom must be wiped clean with a dust-free cloth dipped in alcohol before entering the cleanroom; there must be no contaminants such as oil, rust and dust.
4.1.5 The following items are not allowed to be brought into the cleanroom:
Equipment, spare parts, measuring instruments and other items that have not been cleaned;
Cardboard boxes and untreated recording or note paper, photocopied data, etc.;
Pencils, erasers, ink, etc.;
Cigarettes, cosmetics, toilet paper, food and beverages, etc.;
Operators' personal items such as lighters, jewels, decorations, wallets, keys, handbags, small diaries or other personal items.
4.2 Management of the cleanroom
4.2.1 Tools or materials must be completely off the ground when being moved. They must not be dragged on the ground to avoid scratching the ground.
4.2.2 Tools that generate smoke and dust must not be used.
4.2.3 No waste or unused tools and materials should be left in the cleanroom. Check the surrounding environment at any time. If there is any damage, notify the relevant management personnel immediately.
4.2.4 It is prohibited to drink/eat any food (including water) in the cleanroom.
4.2.5 Playing, making big movements or running in the clean room are prohibited to reduce dust generation.
4.2.6 People are prohibited from gathering or having private conversations unrelated to work in the clean room.
4.2.7 People are prohibited from sitting on the floor in the clean room to reduce dust.
4.2.8 Do not place items or do other work above the air flow in the work area.
4.2.9 The transport forklift used in the clean room should be wiped frequently to keep it clean and should not be mixed with the transport forklift outside the clean room.
4.3 Management of exiting the clean room
4.3.1 Exit the clean room through the designated exit and change shoes in the shoe changing area.
4.3.2 The special slippers after change should be neatly placed on the shoe rack.
4.3.3 It is absolutely forbidden to wear special slippers directly into the general area (non-clean room).
(Figure 2: Cleanroom personnel management)
4.4 Hygiene requirements for clean room personnel
4.4.1 Work clothes and work hats must be neatly worn
4.4.2 Keep hands, nails and face clean and hygienic
4.4.3 People wearing glasses must wash their eyes when entering the clean room
4.4.4 Do not comb your hair in the clean room, and do not touch your hair
4.4.5 Do not use cosmetics or nail polish in the clean room
4.4.6 Do not use jewelry in the clean room
4.5 Clean room environment and hygiene requirements
4.5.1 Indoor stands, products, tools and other items are neatly arranged, and items are strictly prohibited from falling to the ground.
4.5.2 Keep the room at a constant temperature of 23+2℃ and humidity of 70+10%. Check and record before work every day.
4.5.3 Arrange personnel to use vacuum cleaners to clean the room once per shift. The dust collection bag of the vacuum cleaner shall not be disassembled and assembled in the clean room.
4.5.4 Indoor equipment and tools are wiped with dust-free cloth and alcohol every week to keep them clean.
4.5.5 Punching of indoor materials is prohibited, and cutting and tearing of paper and fabrics are prohibited. Documents posted or hung on site must be laminated.
4.5.6 Trash cans are prohibited indoors, and garbage and waste must be promptly moved out of the outdoor garbage storage.
(Figure 3: Hygiene requirements for clean room personnel)
Related Information
What is A CleanRoom management system?
Users often want a clear explanation of what constitutes a cleanroom management system, including its role in maintaining cleanliness, managing contamination, and ensuring that the environment meets specific industry standards.
What are the components of a cleanroom management system?
People are curious about the essential components of the system, such as air filtration (HEPA/ULPA filters), HVAC systems, environmental monitoring tools, contamination control measures, and personnel management protocols.
How do cleanroom management systems help control contamination?
Users ask about how these systems help prevent contamination in controlled environments, including strategies like air flow management, particle monitoring, and proper gowning and hygiene practices for personnel.
What are the key standards and regulations for cleanroom management systems?
Many users want to know which standards and regulations (e.g., ISO 14644-1, GMP, FDA guidelines) a cleanroom management system must comply with to ensure it meets international cleanliness and safety requirements.
How do you monitor and maintain cleanliness in a cleanroom?
This question focuses on the methods used for ongoing monitoring of particle levels, air quality, microbial contamination, and environmental conditions to ensure that Cleanroom standards are met.
What software is used to manage a cleanroom system?
Users are interested in the types of software tools available to manage cleanroom operations, track compliance, monitor air quality, and generate reports on cleanliness, temperature, humidity, and other environmental conditions.
What are the best practices for operating and maintaining a cleanroom?
Many people want to know the best practices for ensuring a cleanroom functions properly, such as proper cleaning procedures, air filtration maintenance, gowning protocols, training for personnel, and ensuring strict operational protocols are followed.
How does a cleanroom management system improve efficiency and safety?
Users want to understand how effective management of cleanroom environments enhances operational efficiency, reduces risks of contamination, maintains product quality, and ensures worker safety in industries such as pharmaceuticals, Electronics, or biotechnology.
