Medical Device Clean Room FAQ

1、What is the role of a medical device clean room?
  Medical device clean rooms play a vital role in the production process of medical devices, which is mainly reflected in the following aspects:
(1) Particle and microbial control: By filtering and purifying the air in the clean room and strictly disinfecting and cleaning the environment, the number of floating and settling bacteria in the air can be effectively reduced, the risk of medical devices being contaminated by microorganisms can be reduced, the microbial safety of the product can be ensured, and patient infection caused by the use of medical devices contaminated by microorganisms can be prevented.
Prevent particle contamination: Clean rooms are equipped with efficient air filtration systems to remove dust particles and other particulate matter from the air. This can prevent particles from adhering to the surface of medical devices or entering the inside of the devices, and prevent particle contamination from affecting the performance, quality and safety of medical devices, such as preventing particles from clogging small channels of medical devices or affecting their optical, electronic and other performance.
(2) Provide a stable production environment: Clean rooms can accurately control environmental parameters such as temperature, humidity, and pressure difference. Stable temperature and humidity help ensure the stability of raw materials and the normal operation of production equipment during the production of medical devices. It also provides a comfortable working environment for operators and improves work efficiency. Reasonable pressure difference control can prevent external polluted air from entering the clean room and maintain the cleanliness of the clean room.
(3) Compliance with regulations and standards: Medical device production must comply with strict regulations and standards, and the construction and operation of clean rooms are important links in meeting these regulations and standards. Only by producing in an environment that meets the corresponding cleanliness requirements can the quality of medical device products be guaranteed, thereby obtaining market access qualifications and enabling products to be legally produced and sold.
(4) Ensuring product quality and consistency: Producing medical devices in a controlled environment of a clean room helps reduce the impact of external factors on product quality and improve the stability and consistency of product quality. This ensures that each batch of medical devices meets the same quality standards, reduces product quality fluctuations, enhances product reliability and repeatability, and helps companies establish a good brand image and market reputation. Enter the clean area.

2、Can medical equipement clean rooms support automation?
  Medical equipment cleanrooms support automation, and automation has many significant advantages and applications in cleanrooms:
(1) Advantages
◆ Reduce the risk of human contamination: People are one of the main sources of contamination in clean rooms. Automated equipment can reduce the activities of people in clean rooms, thereby reducing the risk of microbial and particulate contamination caused by people walking and operating, and help maintain the cleanliness of the clean room.
◆ Improve production efficiency and product quality stability: The automation system can operate accurately according to preset procedures and parameters, ensure the consistency and repeatability of the production process, reduce production deviations caused by human factors, thereby improving production efficiency and product quality stability, and ensuring that each batch of medical devices can meet high and consistent quality standards.
◆ Easy to record and trace data: Automation equipment usually has data recording and monitoring functions, which can record key parameters and operation information in the production process in real time, such as production time, temperature, humidity, equipment operation status, etc. These data not only help quality control and process optimization, but also meet the strict requirements of the medical device industry for product traceability, making it easy to trace and query the production process of the product when necessary.

(2) Application
◆ Automated production equipment: In the clean room of medical equipment, many production links can be automated, such as injection molding, extrusion, assembly, etc. Taking syringe production as an example, the automated production line can complete a series of processes from plastic raw materials to molded syringes, including injection molding, piston installation, needle seat assembly, etc. The whole process is automatically completed in a clean environment, reducing manual intervention and improving production efficiency and product quality.
◆ Material handling system: Automated material handling equipment such as automatic guided vehicles (AGV) and track conveyors can transport raw materials, semi-finished products and finished products in clean rooms, avoiding the contamination and material damage that may be caused by manual handling. These devices can accurately transport materials to designated locations according to the preset path and time, improving the efficiency and accuracy of material flow.
◆ Clean room environment control system: The automated environment control system can monitor and adjust the temperature, humidity, pressure difference, air filtration and other parameters in the clean room in real time to ensure that the clean room always maintains an environmental state that meets production requirements. For example, through the automated air conditioning system and air purification equipment, the temperature and humidity of the air can be automatically adjusted according to the set parameters, and the air filter can be replaced in time to ensure air quality and cleanliness.
◆ Robotics: Robots are increasingly used in clean rooms for medical equipment, and can be used to perform some delicate and complex operations, such as assembly and testing of micro medical devices. Robots are characterized by high precision, high flexibility and repeatability, and can work stably for a long time in a clean environment, improving production efficiency and product quality. At the same time, robots can also be equipped with visual recognition systems and sensors to achieve real-time monitoring and feedback of the production process, further optimizing the production process.

3、What auxiliary areas are needed in medical device clean rooms?
  The auxiliary areas of the medical device clean room are set up to support the normal operation and production activities of the clean room, and usually include the following categories:
(1) Personnel purification area
◆ Dressing room: for personnel entering the clean room to change work clothes, shoes, etc., generally divided into the first and second dressing rooms. The first dressing room is used to change ordinary clothes, and the second dressing room is used to change clean work clothes, wear masks and hats, etc., to reduce dust and microorganisms brought into the clean room by personnel.
◆ Hand washing and disinfection room: Personnel must wash and disinfect their hands before entering the clean room to remove dirt and bacteria from their hands and prevent contamination of medical devices during operation.
◆ Air shower room: It is the only way for personnel to enter the clean room. It uses high-speed clean airflow to blow away dust and particles on the surface of the human body, further purify the personnel and avoid bringing pollutants into the clean room.

(2) Material purification area
◆ Cargo shower room: Similar to the air shower room, it is used to blow and purify materials and equipment entering the clean room to remove dust and particles on the surface and prevent the materials from bringing external pollutants into the clean room.
◆ Material pass through: used to transfer materials between different clean areas or between clean area and non-clean area. The pass through has a double door interlocking function to prevent cross contamination of air during the transfer process and ensure the cleanliness of the clean room.
◆ Outsourcing cleaning room: Clean and remove the outer packaging of materials entering the clean room, remove dust, impurities, etc. on the outer packaging, and prevent these pollutants from entering the clean room.

(3) Equipment maintenance area
◆ Maintenance room: used for daily maintenance, upkeep and repair of production equipment and purification equipment in the clean room. The maintenance room should be equipped with necessary tools and equipment, and its environment should meet certain cleanliness requirements to prevent dust and pollutants generated during the maintenance process from affecting the clean room environment.
◆ Spare parts warehouse: It is used to store spare parts and consumables of clean room equipment so that they can be replaced in time when equipment fails to ensure the continuity of production. The spare parts warehouse should be kept dry and clean to prevent the spare parts from being contaminated and damaged.

(4) Quality control area
◆ Inspection room: Conduct quality inspection on medical device products, including appearance inspection, dimension measurement, performance testing, etc. The inspection room should be equipped with corresponding inspection equipment and instruments, and keep the environment clean to avoid external factors from interfering with the inspection results.
◆ Microbiological testing room: It is specially used for microbiological testing of medical devices, such as bacterial culture, colony counting, sterility inspection, etc. The microbiological testing room needs to have strict aseptic operation conditions, and usually has functional areas such as aseptic operation room, culture room, preparation room, etc.

(5) Storage area
◆ Raw material warehouse: used to store various raw materials required for the production of medical devices, such as plastics, metals, rubber, etc. The raw material warehouse should be classified and stored according to the characteristics of different materials, and kept ventilated and dry to prevent the materials from getting damp and deteriorating.
◆ Finished product warehouse: Stores medical device products that have been completed and passed inspection. The finished product warehouse should have good storage conditions to ensure that the products are not damaged or contaminated during storage and transportation.

(6) Power supply area
◆ Air-conditioning room: Install air-conditioning equipment such as air handling units to provide filtered, purified, temperature-controlled and humidity-controlled air for the clean room, and maintain environmental parameters such as temperature, humidity and cleanliness of the clean room.
◆ Power distribution room: Provides power supply for equipment and lighting in clean rooms and auxiliary areas to ensure the normal operation of the production process.
◆ Compressed air station: produces and supplies clean compressed air for pneumatic equipment, blowing and washing in the production process of medical devices. The compressed air needs to be degreased, dehydrated, filtered, etc. to meet the requirements of the clean room.

(7) Waste disposal area
◆ Waste temporary storage room: used to temporarily store waste generated in the clean room, such as discarded packaging materials, unqualified products, used cleaning supplies, etc. The waste temporary storage room should be cleaned regularly to prevent the accumulation of waste from generating odor and breeding bacteria, which will affect the clean room environment.
◆ Wastewater treatment station: Treat the wastewater generated in the clean room and auxiliary areas to meet environmental standards before discharge. Wastewater treatment stations usually include wastewater collection, sedimentation, filtration, disinfection and other treatment processes. Step by step to optimize production.

4、What materials should be chosen for medical device clean rooms?
  Medical device clean room materials requires comprehensive consideration of many factors to ensure the safety, functionality and comfort of the operating room. The following are some key material selection points:
(1) Wall materials: The wall materials of medical operating rooms must have good antibacterial, washable and corrosion-resistant properties, and at the same time be soundproof and heat-insulating. The surface should be smooth and flat to reduce dust accumulation and bacterial growth. Common metal materials include electrolytic steel plates, stainless steel plates, color steel plates, and non-metal materials such as antibacterial ceramic plates and glass magnesium plates.

(2) Ceiling materials: The ceiling materials of medical operating rooms must meet the requirements of cleanliness, fire resistance, moisture resistance, and sound absorption. At the same time, they must be convenient for installing laminar flow purification equipment and various lighting, monitoring and other facilities. Common materials include aluminum alloy gussets or light steel keel gypsum boards, color steel plates, etc.

(3) Flooring materials: The floor materials of medical operating rooms must have good anti-slip properties to prevent people from slipping and falling. They must also be wear-resistant, corrosion-resistant, easy to clean, able to bear the weight of surgical equipment, and have a certain degree of elasticity to reduce fatigue from standing for a long time. Medical PVC flooring is a common choice. It has the characteristics of anti-slip, antibacterial, wear-resistant, and easy to clean. It comes in a variety of colors and styles and can be matched according to the overall style of the operating room. In addition, rubber flooring also has good anti-slip properties and elasticity, but the color is relatively single.

(4) Door and window materials: The doors of medical operating rooms need to have good sealing properties to prevent outside air and dust from entering the operating room. They should also be easy to open and close and be able to withstand certain impact forces. Windows should ensure good lighting and sealing properties, and should also have certain heat insulation and sound insulation properties.

(5) Electrical materials: The electrical materials used in medical operating rooms must have good insulation and fire resistance to ensure safe use of electricity. At the same time, they must meet the operating room's requirements for the stability and reliability of power supply and be able to adapt to the power needs of various surgical equipment. Wires should be flame-retardant copper core wires that meet national standards, and sockets and switches should be waterproof, dust-proof, and leak-proof medical-specific products. Distribution boxes and distribution cabinets must have overload protection, short-circuit protection and other functions to ensure the safe operation of the power system.

5、What materials should be chosen for medical device clean rooms?
  Medical device clean room materials requires comprehensive consideration of many factors to ensure the safety, functionality and comfort of the operating room. The following are some key material selection points:
(1) Wall materials: The wall materials of medical operating rooms must have good antibacterial, washable and corrosion-resistant properties, and at the same time be soundproof and heat-insulating. The surface should be smooth and flat to reduce dust accumulation and bacterial growth. Common metal materials include electrolytic steel plates, stainless steel plates, color steel plates, and non-metal materials such as antibacterial ceramic plates and glass magnesium plates.

(2) Ceiling materials: The ceiling materials of medical operating rooms must meet the requirements of cleanliness, fire resistance, moisture resistance, and sound absorption. At the same time, they must be convenient for installing laminar flow purification equipment and various lighting, monitoring and other facilities. Common materials include aluminum alloy gussets or light steel keel gypsum boards, color steel plates, etc.

(3) Flooring materials: The floor materials of medical operating rooms must have good anti-slip properties to prevent people from slipping and falling. They must also be wear-resistant, corrosion-resistant, easy to clean, able to bear the weight of surgical equipment, and have a certain degree of elasticity to reduce fatigue from standing for a long time. Medical PVC flooring is a common choice. It has the characteristics of anti-slip, antibacterial, wear-resistant, and easy to clean. It comes in a variety of colors and styles and can be matched according to the overall style of the operating room. In addition, rubber flooring also has good anti-slip properties and elasticity, but the color is relatively single.

(4) Door and window materials: The doors of medical operating rooms need to have good sealing properties to prevent outside air and dust from entering the operating room. They should also be easy to open and close and be able to withstand certain impact forces. Windows should ensure good lighting and sealing properties, and should also have certain heat insulation and sound insulation properties.

(5) Electrical materials: The electrical materials used in medical operating rooms must have good insulation and fire resistance to ensure safe use of electricity. At the same time, they must meet the operating room's requirements for the stability and reliability of power supply and be able to adapt to the power needs of various surgical equipment. Wires should be flame-retardant copper core wires that meet national standards, and sockets and switches should be waterproof, dust-proof, and leak-proof medical-specific products. Distribution boxes and distribution cabinets must have overload protection, short-circuit protection and other functions to ensure the safe operation of the power system.

6、Do different production stages of medical device cleanrooms require different levels of cleanliness?
  Different production stages of medical device cleanrooms usually require different cleanliness levels, which are determined by factors such as the quality requirements of medical devices, production process characteristics, and risk levels. The following are the general requirements for cleanliness levels at different production stages:
(1) Production of non-sterile medical devices
◆ Parts processing: In the process of mechanical processing and molding of medical device parts, the cleanliness requirements are generally relatively low. Usually, a cleanliness level of 100,000 or lower is sufficient, mainly to control general dust and particles to prevent them from contaminating the surface of parts or affecting the subsequent assembly process. For example, some processes such as injection molding of plastic shells and cutting of metal parts can ensure that product quality is not significantly affected in such an environment.

◆ Assembly and debugging: When entering the assembly and debugging stage, the requirements for cleanliness will be higher. Generally, it needs to be carried out in a clean room of Class 10,000 or even higher level to prevent dust, fiber and other impurities from entering the medical device and affecting its performance and reliability. For example, the assembly of electronic components and optical parts of precision medical devices needs to be carried out in a relatively clean environment to prevent tiny particles from having adverse effects on product accuracy and stability.

(2) Production of sterile medical devices
◆ Raw material preparation: For raw materials of sterile medical devices, such as medical grade plastics, rubber, metal materials, etc., the pretreatment stage usually needs to be carried out in a Class 10,000 clean environment. This is to remove impurities and microorganisms on the surface of the raw materials and provide a good foundation for subsequent processing and sterilization procedures. For example, the purchased plastic particles are dried, screened, and processed in a Class 10,000 clean room to ensure that they meet production requirements.

◆ Molding and processing: In the molding and processing of sterile medical devices, such as injection molding, extrusion, and molding, it is generally required to be carried out in a clean environment of Class 10,000 or higher. For some high-risk sterile medical devices that directly contact the human body, such as syringes and infusion sets, their key production processes may need to be completed in a local clean environment of Class 100. This is to minimize the contamination of microorganisms and particles and ensure the sterility and safety of the product.

◆ Packaging and sterilization: The packaging process is usually carried out in a Class 10,000 clean room to prevent the processed sterile medical devices from being contaminated again during the packaging process. The sterilized medical devices should be stored and subsequently processed in a clean environment suitable for the product, such as in a Class 10,000 or higher clean room, waiting for inspection and release.
Medical devices of different types and risk levels may have different cleanliness requirements at different stages of the production process. Enterprises should reasonably design and control the cleanliness of clean rooms based on the specific characteristics of medical devices and relevant regulations and standards to ensure product quality and safety.