The medical ultrasound gel seems simple, but its stable, safe, and efficient production requires a leading production base as support. This base not only needs to have a sufficient scale but also needs to reach high standards in all aspects such as planning and design, equipment configuration, environmental control, and management system.
Exploring the medical ultrasound gel production base built by Pingchuang Medical Group can gain an in-depth understanding of its strong manufacturing capabilities and why it is leading in the industry, winning the favor of global customers.
The Pingchuang Medical production base is located in a region with convenient transportation, covering a total area of 16,000 square meters. The large scale first provides sufficient space for functional zoning. The production area, quality control area, warehousing area (including raw material warehouse, packaging material warehouse, finished product warehouse), research and development center, and office area are planned and laid out in a clear manner, with a smooth logistics flow line. This scientific planning is conducive to improving operational efficiency and is also convenient for implementing strict zoning management to prevent cross-contamination.
The core highlight of the base is its 3,000 square meter ten-thousand-level clean room production area. This is designed and built specifically for the production of products with extremely high cleanliness requirements (such as medical ultrasound gels). The internal use of building materials that meet clean standards, equipped with high-efficiency air filtration systems (HEPA), and strict environmental control measures (temperature and humidity, pressure difference, dust particle, microorganism monitoring) are implemented. All personnel and materials entering this area must go through a purification process. This high-standard clean environment is the key to ensuring the purity and safety of the ultrasound gel, and is also an important symbol of Pingchuang Medical's leading manufacturing capabilities.
In terms of equipment configuration, the Pingchuang Medical production base reflects advancedness and professionalism. The batching system uses high-precision weighing equipment to ensure accurate proportion of the formula. The core mixing and homogenization processes use hygienic stainless steel materials and vacuum emulsification mixing equipment that meets GMP requirements, which can efficiently prepare a gel with uniform texture and no bubbles. The filling line is equipped with corresponding automated or semi-automated equipment according to different packaging forms (bottles, tubes, bags), with high filling accuracy and tight sealing. The packaging equipment in the later stage is also gradually automated, improving packaging efficiency and quality.
Quality control is an indispensable and important part of the production base. Pingchuang Medical has established an independent and fully equipped QC laboratory. The laboratory is equipped with advanced testing instruments such as digital rotational viscometers (to test viscosity at different shear rates), precise pH meters, conductivity meters, sound velocity meters, and a complete set of equipment for microbial limit testing and sterility testing (if applicable). These precise instruments ensure that the key indicators of raw materials, semi-finished products, and finished products can be accurately and reliably tested, providing data support for product quality.
The operation and management of the entire production base strictly follows international standards. The ISO 13485 medical device quality management system and GMP production management specifications are fully implemented. This means that all activities of the base, from supplier management, material control, production operations, equipment maintenance, personnel training to record keeping, non-conforming product handling, and continuous improvement, have standardized processes and strict supervision. A comprehensive information system (such as ERP) is also applied to the management of the base, enhancing operational efficiency and data accuracy.
