1.What is a medical device clean room?
A medical device clean room is a specially designed room that removes dust particles, harmful gases, bacteria and other pollutants from the air and controls the cleanliness, pressure, temperature, humidity, air flow speed and distribution, noise, illumination and static electricity in the room within a specific range. It is suitable for the production and inspection process of medical devices to ensure that the cleanliness, temperature and humidity of the environment in which the product is located are controlled within an appropriate range, thereby ensuring the safety and effectiveness of medical devices .
Medical device cleanrooms are mainly used for the production of sterile and implantable medical devices, in vitro diagnostic reagents and other products. For example, medical devices such as intravascular stents, orthopedic implants, and in vitro diagnostic reagents that require terminal sterilization or aseptic processing technology are all produced and inspected in cleanrooms. In addition, cleanrooms are also suitable for medical device varieties that require control of initial contamination bacteria, such as dialysis powder (liquid) and single packaging that is in direct contact with the product .
2. What regulations do medical device clean rooms need to comply with?
The main regulations that medical device clean rooms need to comply with are:
(1)Domestic regulations
◆ "Medical Device Supervision and Administration Regulations": As the basic law for medical device supervision, it stipulates the supervision and management requirements for each stage of medical device development, production, operation, and use. Clean rooms are an important environment for medical device production, and their construction, operation, and management must comply with the relevant provisions of the regulations to ensure the quality and safety of medical device products.
◆ "Good Manufacturing Practice for Medical Devices": It puts forward specific requirements on the organization and personnel, factory buildings and facilities, equipment, document management, production management, quality control, etc. of medical device manufacturers. The design, construction, maintenance and personnel operation of clean rooms should comply with this practice to ensure the standardization of the medical device production process and the stability of product quality.
◆ "Sterile Medical Device Production Management Standard" (YY/T 0033 - 2000): A management standard specifically for the production of sterile medical devices. It specifies in detail the requirements for clean room (area) environmental control during the production process of sterile medical devices, including cleanliness level, personnel hygiene, material purification, equipment and facilities, etc. It is an important basis for the construction and management of clean rooms for medical devices.
◆ "Design Standard for Clean Rooms in Pharmaceutical Industry" (GB 50457-2019): Provides standards for the design of clean rooms in pharmaceutical industry. It is applicable to the design of new, renovated and expanded clean rooms in pharmaceutical industry. It puts forward specific requirements for the architectural layout, air purification system, process water system, electrical system, etc. of the clean room. The design of clean rooms for medical devices can refer to this standard.
◆ "Cleanroom Design Specifications" (GB 50073 - 2013): It stipulates the basic principles, design requirements and technical measures for cleanroom design. It is applicable to the design of new, rebuilt and expanded cleanrooms. It is one of the important reference bases for the design and construction of clean rooms for medical devices.
(2)International regulations
◆ ISO 14644: Standards issued by the International Organization for Standardization, covering all aspects of the design, construction, testing and operation of clean rooms and related controlled environments. ISO 14644-1 defines different cleanliness levels and provides an internationally accepted standard for the classification and acceptance of clean rooms for medical devices.
◆ Related regulations of the U.S. Food and Drug Administration (FDA): Although the FDA's current good manufacturing practices (cGMP) are mainly aimed at drugs and foods, they are also widely used in the medical device manufacturing industry. They impose strict requirements on the equipment, methods, and controls of medical device clean rooms to ensure the safety and effectiveness of medical device products.
◆ EU Medical Device Regulation (MDR): The new version of the Medical Device Regulation has put forward more stringent requirements for the marketing and production of medical devices, including requirements for a clean production environment. If medical device companies want to export their products to the EU market, their clean rooms must meet relevant requirements.
3.What cleanliness level does a medical device clean room need to achieve?
The cleanliness requirements of medical device cleanrooms vary according to the risk level and purpose of the medical device. Generally speaking, the cleanliness requirements of medical device cleanrooms can be divided into the following levels:
(1) Class I medical devices: The cleanliness level of the workshop must reach Class 300,000 (ISO 8), which is suitable for low-risk products such as disposable gloves, bandages, etc.
(2) Class II medical devices: The cleanliness level of the workshop must reach Class 100,000 (ISO 7), suitable for medium-risk products such as syringes, infusion sets, etc.
(3) Class III medical devices: The cleanliness level of the workshop is required to reach Class 10,000 (ISO 5) or higher, and some areas even need to reach Class 100 (ISO 4) cleanliness standards. It is suitable for high-risk products such as implantable medical devices, intravascular catheters, etc.
In addition, the cleanliness requirements for different types of medical devices are also different:
(1) Medical devices implanted or inserted into blood vessels, such as vascular stents and heart valves, are required to be processed and assembled in a clean area of Class 10,000 or above.
(2) Medical devices implanted in human tissues, such as pacemakers and subcutaneous drug delivery devices, are required to be processed and assembled in a clean area of Class 100,000 or above.
(3) Medical devices that come into contact with damaged surfaces and mucous membranes of the human body, such as burn dressings and medical cotton wool, are required to be produced in a clean area of Class 300,000 or above.
4.Why do medical device clean rooms require terminal sterilization?
Medical device cleanrooms require terminal sterilization for the following reasons:
(1) Ensure microbial safety: During the production process of medical devices, although the clean room environment is strictly controlled, it is still difficult to completely avoid microbial contamination. These microorganisms may come from the air, personnel, equipment or raw materials. Terminal sterilization can kill or remove residual microorganisms on medical devices, including bacteria, viruses, fungi, etc., through physical or chemical methods such as high temperature, radiation, chemical disinfectants, etc., thereby preventing infection after use by patients and ensuring patient safety.
(2) Comply with regulations and standards: Relevant medical device regulations and standards, such as the "Good Manufacturing Practice for Medical Devices", clearly stipulate the microbial limit requirements for medical device products. Terminal sterilization is a key step in ensuring that products comply with these regulations and standards. Only medical devices that have undergone terminal sterilization and meet the microbial indicators can enter the market for sale and use.
(3) Improving product quality and stability: The presence of microorganisms may affect the performance and quality of medical devices, such as causing material deterioration and impaired device function. Terminal sterilization can eliminate the potential threat of microorganisms to product quality, improve the stability and reliability of medical devices, and ensure that the product can function normally within the specified validity period.
(4) Adaptability to different usage scenarios: Many medical devices, such as syringes and implantable devices, will directly contact human tissue or enter the human body when in use. These devices must undergo strict sterilization to prevent microorganisms from entering the human body and causing infection. Even some non-invasive medical devices, such as in vitro diagnostic equipment, need to be terminally sterilized to avoid microbial contamination during use that may affect the accuracy of test results.
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.
7.What are the types of medical cleanrooms? What’s their application respectively?
A medical cleanroom is a space that removes pollutants such as particles, harmful gases and bacteria from the air while controlling parameters like temperature, humidity, cleanliness, pressure, air velocity/distribution, noise, vibration and illumination at a required range. The followings are some common types and applications:
① General Operating Theater: A general operating theater is a place in a hospital where routine surgeries are performed, usually with cleanliness 10,000 or 100,000, equipped with basic air purification systems and disinfection equipment, meeting the environmental cleanliness requirements of general surgeries, preventing postoperative infections, and suitable for general surgical and diagnostic routine surgical procedures.
② Laminar-flow Operating Theater: The laminar flow operating theater requires not only highly clean air, but also the control of the air flow direction. It is suitable for operations requiring high cleanliness and infection control, such as heart surgery, neurosurgery, ophthalmology, organ transplantation, burn surgery, infectious diseases surgery, etc.
③ Medical Device Production Cleanrooms: The medical device cleanroom strictly follows industry regulations and designed according to the risk level of different products to ensure the sterility, safety, and controllable quality of medical devices. Generally speaking, for the assembly of ordinary sterile instruments and the production of in vitro diagnostic reagents, a relatively low cleanliness (ISO 7) cleanroom can meet the requirements, while for high-risk implants, sterile filling and other products, a higher cleanliness level (ISO 5) cleanroom is required. In addition, the cleanliness requirement for auxiliary areas is usually ISO 8.
④ Medical Research Cleanrooms: A medical research cleanroom is a special environment with high cleanliness. Not only requires strict control of microorganisms, but also precise control of environmental parameters such as temperature, humidity, airflow velocity, and room pressure, which is typically used for research in genetic engineering, cancer, infectious diseases, vaccines, and more.
⑤ Pharmaceutical production clean room: The production of drugs not only has extremely high sensitivity to microorganisms, but also many process steps have extremely strict requirements for environmental temperature and humidity. Pharmaceutical cleanrooms provide a sterile, constant temperature, constant humidity and other strictly controlled environment that meets production requirements, ensuring the purity and safety of production, and improving product yield and quality. This type of clean room is usually used in the production of sterile preparations (such as eye drops, injections, etc.), cell culture and fermentation, and other fields.
8.Why does a medical cleanroom requires negative pressure design?
(1)The negative pressure design principle of medical cleanrooms: By making the indoor air pressure lower than the external environment, an airflow is formed from the outside to the inside to ensure that pollutants do not leak out. Specifically, there are the following points:
● Air pressure control: Negative pressure medical cleanrooms maintain indoor air pressure lower than adjacent areas through air conditioning purification systems, forming a stable pressure gradient from outside to inside.
● Air flow management: Air flows from clean areas to polluted areas, then directed out through exhaust systems to reduce the risk of air leakage when opening doors.
● Filtration and disinfection system: The exhaust system is equipped with a high-efficiency air filter (HEPA) that filters over 99.997% of 0.3 micron particles, and even adds ultraviolet disinfection or chemical disinfection devices.
(2)Reasons for adopting negative pressure design in medical cleanrooms
● Isolate infectious pathogens to prevent their transmission through the air: In some medical settings, such as infectious disease wards, special drug production workshops may exist harmful microorganisms, viruses, or toxic substances. Negative pressure design ensures that indoor pressure is lower than the surrounding environment, and air can only flow from clean areas to polluted areas, effectively preventing these pollutants from leaking into adjacent clean areas with the air and avoiding the spread of pollution to other wards, corridors, or the entire hospital environment.
● Ensuring the safety of medical staff and patients: For clean rooms that handle highly pathogenic microorganisms or toxic drugs, negative pressure design can ensure that harmful substances will not leak into the outdoor environment even in the case of equipment failure or operational errors, ensuring the health and safety of surrounding personnel and preventing operators from inhaling toxic substances.
9.What standards do medical cleanrooms need to meet?
Here are some common design standards and specifications for medical cleanrooms:
● The Code for Design of Cleanroom(GB 50073-2013) specifies the basic principles, design requirements, and construction standards for cleanroom design, which is applicable to the design of newly built, renovated, and expanded cleanrooms. Specific regulations have been made for the air cleanliness level, building structure, air conditioning, water supply and drainage, electrical and other aspects of the clean room.
● Standard for Design of Pharmaceutical Industry Clean Room (GB 50457-2019): Applicable to the design of newly built, expanded, and renovated cleanrooms in the pharmaceutical industry. The production and quality inspection facilities for biological products, toxic drugs, psychotropic drugs, anesthetics, and radioactive drugs shall comply with relevant national regulatory regulations in addition to this standard. This standard provides detailed requirements for environmental parameters, air cleanliness, building layout, and personnel and material in pharmaceutical cleanrooms.
● Buildings & Technical Specification for Hospital Clean Operating Department (GB 50333-2013) specifies the technical requirements for building design, air conditioning, purification, and infection control of hospital clean operating departments, providing a basis for the construction and management of hospital clean operating departments.
● Environmental Control Requirements for Negative Pressure Isolation Wards in Hospitals(GB/T 35428-2017): specifies the environmental control requirements for negative pressure isolation wards in hospitals, including negative pressure indicators, ventilation, air purification, etc., to ensure that negative pressure isolation wards can effectively isolate pathogens and protect the medical staff and other patients.
● ISO 14644 series: Standards published by the International Organization for Standardization, covering all aspects of the design, construction, testing, and operation of cleanrooms and related controlled environments. Among them, ISO 14644-1 defines different cleanliness levels, providing an internationally recognized standard for the design and acceptance of medical cleanrooms.
● The US Federal Standard FS209EEC: The world's earliest cleanroom standard was born, the cleanroom air cleanliness level was first classified, laying the foundation for the development of global cleanroom standards. After its revocation, it still has a certain impact on cleanroom standards in some industries.
10.What documents need to be prepared before the construction of a medical cleanroom?
Before the construction of medical cleanrooms, various materials need to be prepared to ensure the smooth progress and compliance with relevant regulations and requirements. Here are some main materials:
① Project basic documents:
● Approved government documents: Before construction, a project feasibility report must be provided, which shall be approved by local government to ensure the feasibility and legality of the project.
● Collecting relevant design basis, including land use certificates, site topographic maps, geological survey reports, etc., which are helpful to understand the basic situation of the site and provide a basis for the selection of clean room locations and basic design.
● Relevant qualification certificates of the construction party, such as the practicing license of medical institutions, proving that the institution has the qualification to construct medical clean rooms.
② Relevant design data
● Design brief:Clarifying the usage function, scale, level, process requirements, etc. It's the basis for the design work.
● Relevant policies, norms, and standards: Collect relevant norms and standards on the design, construction, and acceptance of medical cleanrooms at home and abroad to ensure that the design and construction meet industry requirements.
● Design base map and local environmental conditions: including the overall floor plan, floor plan, section plan, elevation plan, etc. of the building where the cleanroom located, and collect local meteorological data, hydrogeological data, and environmental conditions of surrounding air pollution to understand the overall structure and layout of the building, determine the relationship between the cleanroom and the surrounding environment, and the connection method with other parts of the building.
● Process flow and equipment layout: Detailed description of the medical operation process in the medical cleanroom, as well as the placement of various medical equipment and facilities, so that designers can make reasonable plane layout and airflow organization design based on this, and finalize the cleanliness, temperature and humidity, pressure difference and other design requirements of the cleanroom.
● Cost budget report: Clearly define the total investment budget of the project, including construction costs, equipment procurement costs, installation and commissioning costs, personnel training costs, etc., in order to control costs during the construction process.
11.What core factors should be considered in the design of medical operating rooms?
The main core factors that need to be considered in the design of medical operating rooms are:
① Functionality: Based on specific requirements and equipment placement, plan the spatial layout of the operating room reasonably, clearly divide each functional area, and ensure sufficient turnover and operation space.
② Safety: When providing stable gas supplies such as medical oxygen, nitrous oxide, compressed air, etc., medical operating rooms need to be equipped with gas monitoring and alarm devices to ensure that the quality and pressure of the gas meet the surgical requirements. At the same time, to ensure the rapid and safe evacuation of personnel in emergency situations, automatic fire alarm systems and firefighting equipment should be equipped in medical operating rooms, and evacuation routes and safety exits should be designed reasonably.
③ High cleanliness: Medical operating rooms should have efficient air filtration systems to meet the requirements of air cleanliness, and reduce the risk of surgical infections through reasonable airflow organization and air purification measures.
Environmental comfort: Medical operating rooms can strictly control parameters such as temperature and humidity, providing a comfortable environment for patients and medical staff, which is conducive to the smooth progress of surgery and the work efficiency of personnel. At the same time, the medical operating room is also designed with comfortable lighting and noise control according to the needs of different operations, creating a quiet surgical environment for medical staff and reducing external interference.
12.What’s the clean class of the laminar airflow ceiling in operating rooms?
According to the requirements of air cleanliness and microbial concentration, the laminar flow clean class in operating rooms is usually divided into the following categories:
(1)Class 100 (ISO Level 5): Class 100 laminar flow ceiling requires no more than 3,520 particles ≥ 0.5 microns and no more than 5 planktonic bacteria per m³ of air, which is suitable for surgeries that require a highly sterile environment, such as heart surgery, organ transplantation, high-risk orthopedic surgeries (such as joint replacement), neurosurgery, etc.
(2)Class 1,000 (ISO Level 6): Class 1,000 laminar flow ceiling requires that the number of particles ≥ 0.5 microns per m³ of air should not exceed 35,200, and the number of planktonic bacteria 75, which is suitable for most routine surgeries, such as general surgery (such as laparoscopic surgery), ophthalmic surgery, plastic surgery, etc.
(3)Class 10,000 (ISO 7 level): Class l0,000 laminar flow ceiling requires that the number of particles ≥ 0.5 microns per m³ of air should not exceed 352,000, and the number of planktonic bacteria 150, which is suitable for surgical environments with low cleanliness requirements, such as general outpatient surgery, minor trauma surgery, non-invasive examinations (such as endoscopy), etc.
(4)Class 100,000 (ISO 8 level): Class 100,000 laminar flow ceiling requires that the number of particles ≥ 0.5 microns per m³ of air should not exceed 3,520,000, and the number of planktonic bacteria 400, which is mainly used in auxiliary areas such as instrument preparation rooms, drug preparation rooms, low-risk outpatient operations, etc. It is not directly applicable in surgical operations.
13.Is unidirectional airflow or bidirectional airflow applicable for medical operating rooms?
Unidirectional airflow is more suitable for medical operating rooms, here are the reasons:
● Effective pollution control: Unidirectional airflow, such as laminar flow systems, makes the air flow along parallel streamlines at a uniform speed and direction, quickly discharging indoor pollutants such as dust and microorganisms, avoiding the accumulation and diffusion indoors, preventing secondary pollution of the surgical area by pollutants generated during the surgical process, effectively reducing the risk of surgical infection, and providing a highly clean environment for surgery.
● Maintain stable cleanliness: Unidirectional airflow forms a stable airflow barrier in the surgical area, isolating the surgical area from the surrounding environment and reducing the interference of external factors on the cleanliness of the surgical area. In contrast, bidirectional airflow may cause turbulence, mixing clean air with polluted air, making it difficult to maintain the high cleanliness environment required in the surgical area.
● Pressure difference requirement: Medical operating rooms usually need to maintain a positive pressure state to prevent external air pollution from entering. The unidirectional airflow system better controls indoor air pressure and ensures stable maintenance of positive pressure through reasonable supply and return air design. However, bidirectional airflow is relatively complex in pressure control and may affect the stability of indoor pressure due to the interaction of airflow.
14.Is unidirectional airflow or bidirectional airflow applicable for medical operating rooms?
Unidirectional airflow is more suitable for medical operating rooms, here are the reasons:
● Effective pollution control: Unidirectional airflow, such as laminar flow systems, makes the air flow along parallel streamlines at a uniform speed and direction, quickly discharging indoor pollutants such as dust and microorganisms, avoiding the accumulation and diffusion indoors, preventing secondary pollution of the surgical area by pollutants generated during the surgical process, effectively reducing the risk of surgical infection, and providing a highly clean environment for surgery.
● Maintain stable cleanliness: Unidirectional airflow forms a stable airflow barrier in the surgical area, isolating the surgical area from the surrounding environment and reducing the interference of external factors on the cleanliness of the surgical area. In contrast, bidirectional airflow may cause turbulence, mixing clean air with polluted air, making it difficult to maintain the high cleanliness environment required in the surgical area.
● Pressure difference requirement: Medical operating rooms usually need to maintain a positive pressure state to prevent external air pollution from entering. The unidirectional airflow system better controls indoor air pressure and ensures stable maintenance of positive pressure through reasonable supply and return air design. However, bidirectional airflow is relatively complex in pressure control and may affect the stability of indoor pressure due to the interaction of airflow.
15.What’s the advantage of medical modular cleanroom?
Medical modular cleanroom is a cleanroom system that adopts a modular design concept, dividing the cleanroom into multiple relatively independent functional modules and then combining them for installation. In the application of medical field, the following are the advantages of modular medical cleanrooms:
① Efficiency and flexibility: Most components of the modular cleanroom are prefabricated and tested in the factory, and only need to be assembled on site, greatly reducing the construction time. At the same time, modular design allows highly customized solutions based on specific customer needs. Different modules can be combined to create clean spaces of various shapes and sizes, meeting the needs of enterprises from small laboratories to large production workshops. It enables enterprises quickly respond to market demands and start production or research activities quickly.
② Cost and quality are controllable: The components of the modular cleanroom are prefabricated in the factory, reducing the time and labor required for on-site construction. Moreover, the modular cleanroom is easy to replace and upgrade, reducing maintenance downtime and thus lowering construction costs. At the same time, the modules are produced in the factory according to strict quality standards and process flow, with a relatively stable production environment that is not affected by external factors such as weather and site, thus ensuring the quality and accuracy of the modules.
③ High quality clean environment: The modular medical cleanroom adopts advanced air purification technology and sealing design, which effectively control indoor dust particles and microbial pollution, meeting different levels of cleanliness requirements. The connections between various modules are airtight and good sealing, reducing the risk of air leakage and cross contamination, providing a highly clean and safe environment for medical operations.
④ Environmental protection and sustainability: Modular cleanrooms adopt energy-saving technologies and efficient insulation materials, effectively reducing energy consumption and operating costs. Its materials have a high degree of reusability, in line with the principles of sustainable development, reducing resource waste and environmental burden. The use of renewable materials and environmentally friendly technologies in the design and construction process further reduces the impact on the environment.
⑤ Adaptability and reliability: Modular cleanrooms can be easily expanded or reconfigured according to different practical needs, adapting to the performance and quality requirements of cleanrooms in different production periods. In addition, modular cleanrooms can adapt to the usage demand of different environmental conditions, including the adjustment and control of parameters such as temperature, humidity, and pressure.
16.How to choose the materials used in medical operating rooms? What are the features?
The selection of materials for medical operating rooms need comprehensive consideration of multiple factors to ensure the safety, functionality and comfort of the operating room. Here are some key points:
(1)Wall material: The wall material of medical operating rooms should be antibacterial, cleaning resistant and corrosion-resistant, as well as sound insulation and thermal insulation. The surface should be smooth and flat to reduce dust accumulation and bacterial growth. Common wall materials include electrolytic steel plates, stainless steel plates, sandwich panel, as well as non-metallic materials such as antibacterial ceramic plates and glass magnesium plates.
(2)Roof material: The roof material should meet the requirements of cleanliness, fire prevention, moisture resistance, sound absorption, etc., and should also be easy to install laminar flow purification equipment and various lighting, monitoring and other facilities. Common materials include aluminum alloy buckle plates, light steel keel gypsum boards, sandwich panels, etc.
(3)Flooring material: The flooring material should be anti-slip to prevent personnel from slipping and falling; At the same time, it should be wear-resistant, corrosion-resistant, easy to clean, able to withstand the weight of surgical equipment, and elastic to reduce fatigue from standing long time. Medical PVC flooring is a regular choice, which have the features of anti slip, antibacterial, wear-resistant, and easy to clean. There are a variety of colors and styles for option, and can be matched according to the overall style of the operating room. In addition, rubber flooring is anti-slip and elastic, but the color is relatively single.
(4)Door and window: The doors should be good-sealed to prevent external air and dust from entering the operating room. And easy to open and close, able to withstand certain impact forces. Windows should ensure good lighting and sealing, while also be heat-insulating and sound-insulating.
(5)Electrical materials: The electrical materials used in medical operating rooms should have good insulation and fire resistance to ensure electrical safety. At the same time, it is necessary to meet the stability and reliability requirements of power supply in the operating room, which able to adapt to the electricity needs of various surgical equipment. The wires should be flame-retardant copper core wires that meet national standards, and sockets and switches should be medical grade products that are waterproof, dustproof, and leak proof. Distribution boxes and cabinets should have functions such as overload protection and short circuit protection to ensure the safe operation of the power system.