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2019.11.07
Through-wall design for pharmaceutical equipment
The design of the through-wall design of pharmaceutical equipment refers to the layout of a part of the equipment across the partition wall to another room in order to save the area of the process area; The transmission, control, and maintenance positions of the equipment are set in the auxiliary area. Through engineering and technical measures, the layout of two different levels of clean areas is ensured.
2020.05.08
The National Center for Innovation in High-Performance Medical Devices has been established in Shenzhen.
On May 8, Liu Fang, a reporter from Shenzhen News (a publication of China Youth Daily and China Youth Net), reported that the Shenzhen Municipal Bureau of Industry and Information Technology informed reporters that the Ministry of Industry and Information Technology has approved the upgrade of the Guangdong Province High-Performance Medical Device Innovation Center to the National High-Performance Medical Device Innovation Center. The center will be supported by the Shenzhen National Institute for High-Performance Medical Devices and will begin its establishment work. This is the only national manufacturing innovation center in the medical device sector, and it will become the most important hub for medical devices in China’s life safety and biosafety fields. High-end medical equipment is a critical support and reliance for the diagnosis and treatment of serious diseases. For a long time, China’s domestic high-end medical device industry has lacked core technologies, with weak innovation capabilities and significant gaps compared to international advanced technologies in areas such as technology, quality, and design. As a result, both international markets and even the domestic market share have been monopolized by global giants. Take, for example, the artificial device known to all during the COVID-19 pandemic—the ECMO (also called an artificial lung)—which is essential for saving critically ill COVID-19 patients. However, due to difficulties in overcoming challenges related to core components and materials, China currently relies heavily on imports. Localizing high-end medical equipment has become an urgent priority. Yet, since the research and development of advanced medical devices involves multidisciplinary integration and system-level integration, addressing the technological challenges in the innovative development of high-end medical devices requires strategic planning, coordinated collaboration among multiple stakeholders, and joint R&D efforts that combine cutting-edge technologies with general, foundational technologies.
Wall-penetrating design for pharmaceutical equipment
The wall-penetrating design for pharmaceutical equipment refers to a layout in which part of the equipment is arranged across a partition wall into another room, thereby saving processing space. The equipment’s transfer, control, and maintenance areas are located in auxiliary zones. Through engineering and technical measures, this layout ensures proper separation between two different levels of cleanrooms. (1) Saving on Factory Space Costs Pharmaceutical production has strict requirements for the production environment. By reducing the area required for clean zones without compromising the production process or operational efficiency, environmental costs can be lowered. With the wall-penetrating design, the equipment itself occupies less process space, directly impacting factory utilization. (2) Promoting Self-Cleaning of Plants and Equipment Due to the maintenance needs of traditionally designed pharmaceutical equipment, components such as covers must be made detachable, which makes sealing difficult. In wall-penetrating pharmaceutical equipment, the side facing the high-grade clean zone is installed permanently and does not require disassembly after installation. As a result, the equipment can be designed as fixed or integral units, reducing the number of joints and connections, giving the equipment a neat appearance, and facilitating the purification of the process area through cleaning and disinfection. (3) Optimizing the Design and Manufacturing of the Equipment Itself In conventionally designed equipment, components may rust, lubricants from transmission parts may leak, debris may accumulate from friction between pulleys and belts, or necessary inspection doors may introduce contaminants into the process area. After adopting stringent isolation measures between the process area and auxiliary areas in wall-penetrating equipment layouts, these issues can be confined to the auxiliary areas. Consequently, the design of the process area can meet cleanliness requirements more effectively, while also addressing challenges related to strength, transmission, heat dissipation, and cost, thus optimizing the equipment design to comply with GMP standards. (4) Reducing Noise and Improving Workplace Comfort By placing transmission equipment in auxiliary areas and using isolation measures, transmission noise can be significantly reduced, contributing to a more comfortable working environment. (5) Convenient Equipment Operation The wall-penetrating layout allows for the installation of touch screens and other operating interfaces directly on the wall, freeing up space in the process area and making it easier to use and clean these interfaces. (6) Easy Maintenance The overall design of wall-penetrating equipment centralizes various auxiliary areas for equipment maintenance. On one hand, this reduces the length of pipelines for water, electricity, gas, and steam supplied by the plant, simplifying maintenance of plant facilities and lowering operational costs. On the other hand, dedicated maintenance areas specifically designed for pharmaceutical equipment facilitate the connection and installation of utilities such as water, electricity, gas, steam, and equipment itself, thereby promoting comprehensive maintenance of both the equipment and the plant. (7) Maintenance Work Does Not Affect the Process Area After isolating the main equipment, maintenance work can be carried out in the maintenance area, preventing communication between different levels of clean zones during maintenance operations and thus preserving the cleanliness of the process area. In this way, the wall-penetrating layout enables maintenance without disrupting the production of other equipment, ensuring that maintenance activities have minimal impact on product quality and fully comply with GMP requirements.
Leveraging technological innovation to build “national prominence” for medical devices.
On April 28, 2020, the Ministry of Industry and Information Technology approved the upgrade of the Guangdong Province High-Performance Medical Device Innovation Center to the National High-Performance Medical Device Innovation Center (hereinafter referred to as the Innovation Center).
