Discover our solutions for medical devices
The safety and effectiveness of medical devices are central issues in the medical field, directly impacting patients' health and lives. To ensure the quality of medical devices, especially those that require a sterile state, the use of GMP (Good Manufacturing Practice) clean rooms is particularly crucial. Aosheng provides comprehensive system solutions that comply with medical device GMP design specifications, offering purification products such as HEPA/ULPA high-efficiency air filters, FFUs, laminar flow hoods, transfer windows, air showers, and sterilization equipment, effectively removing particles and microorganisms from the air. Easy-to-clean, antistatic, and wear-resistant wall and floor materials effectively prevent dust accumulation. Additionally, temperature and humidity control and monitoring systems are provided to ensure that medical devices are produced and stored under optimal conditions.
Efficiently Purified Air
GMP Standards
Enhance Product Safety
Improve Product Quality
Applications
Walls and Floor
Wall Panel Material
- Select fire-resistant, moisture-proof, and antibacterial wall panels specifically designed for cleanrooms, such as color-coated steel plates, rock wool sandwich panels, etc.
- The wall panel design should facilitate easy removal, cleaning, and maintenance.
Floor material
- It is recommended to use wear-resistant, anti-slip, and easy-to-clean medical-grade flooring such as PVC flooring, epoxy resin flooring, etc.
- Ensure that the flooring material meets cleanroom standards, featuring no gaps and being easy to disinfect.
Ceiling & lighting system
Ceiling Material
- It is recommended to use ceiling materials that are easy to clean and corrosion-resistant, such as color-coated steel panels or aluminum alloy panels.
- A concealed lighting system and ventilation ducts should be installed within the ceiling to ensure adequate indoor lighting and air circulation.
lighting system
Cleanroom lighting generally uses clean fluorescent lamps or LED lamps. These lamps should have good sealing performance to prevent dust and moisture from entering. The lighting intensity should meet the requirements of production operations. Generally, it is between 300 and 500 lux. At the same time, shadows and glare should be avoided to ensure that operators can clearly see production details.
Door and Windows
Door
Utilize materials that are corrosion-resistant, high-strength, abrasion-resistant, and easy to clean: color-coated steel doors, stainless steel doors, galvanized steel plates, and melamine resin board doors.
Window material
The door and window materials should be specialized for dust-free rooms, ensuring tight sealing and cleanliness.
Air Purification System
During the production process of lithium batteries, a significant amount of dust and harmful gases are generated. Besides requiring HEPA/ULPA air filters, FFU, and high-efficiency air supply outlets for purifying particulate matter, chemical filters are also necessary to remove harmful gases and prevent corrosion and damage to electronic components. Additionally, to avoid contamination from the movement of personnel and cargo, equipment such as transfer windows and air showers are required.
Temperature and Humidity Control System
The temperature and humidity control system in medical device clean rooms is a crucial aspect for ensuring the stability and safety of medical devices during production, storage, and use.
Strict temperature and humidity control:According to the production and storage requirements for Class II medical devices, the temperature in clean rooms generally needs to be controlled within the range of 18-28°C, and the relative humidity should be maintained at 45%~65% RH. n medical device cleanrooms, the use of rotary dehumidifiers is an efficient and reliable method for humidity control.
High accuracy and stability: Advanced sensors and control systems are employed to achieve temperature fluctuations within ±0.5°C and humidity fluctuations within ±3%RH, ensuring long-term stable operation.
Intelligent management: Integrated with Internet of Things (IoT) technology, it enables remote monitoring, intelligent regulation, and data visualization, improving management efficiency and ensuring production safety.
Energy-saving and environmentally friendly: Optimized control algorithms and energy-saving equipment are adopted to reduce energy consumption and comply with environmental protection requirements.
Furniture for medical device cleanroom
The furniture in medical device clean rooms is made of stainless steel or aluminum alloy, which are easy to clean, corrosion-resistant, and have smooth surfaces. This includes stainless steel workbenches, storage cabinets, shelves, ultrapure worktables, lockers, handcarts, handwashing sinks, and other items.
Our Services
Planning and Design services for medical device cleanroom
● To understand the requirements and objectives of your medical device cleanroom project, we will conduct assessments and investigations into the project's budget allocation, project timeline, spatial planning, and other relevant aspects, ensuring that the project complies with GMP standards and other regulations, and achieving the anticipated results.
● For your medical device cleanroom project, we will provide detailed design drawings, encompassing structural components, HVAC systems, control systems, electrical parts, clean utilities, process equipment, etc.
Standardized or customized products for medical device cleanroom
● We provide a wide range of standard-specification products for medical device cleanrooms, including high-quality wall panels, ceilings, floors, lighting, purification equipment, sterilization equipment, pure water equipment, HVAC systems, laboratory furniture, and more.
● In addition to our portfolio, we are experienced with customizing, reconfiguring, and designing components to serve your needs, no matter how unique or unusual.
Compliance consulting services for medical device cleanroom
● Our team possesses extensive knowledge and practical experience in medical device cleanrooms, and is well-versed in GMP regulations and ISO standards. We provide compliant advice to optimize project design, layout, and manufacturing processes, ensuring that your project meets the necessary regulatory standards while fulfilling your process requirements. Our GMP consulting services are designed to support cleanroom users in navigating the complex requirements of Good Manufacturing Practices (GMP).
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