For medical ultrasound gel, which directly affect the results of diagnosis and patient safety, it is crucial to ensure that the quality of each batch of products is stable, reliable, and meets standards. Any deviation in quality of a batch may lead to serious consequences. Therefore, whether the manufacturer has and effectively operates a strict quality control (QC) system is a core standard for measuring its reliability.
The quality control system of Pingchuang Medical is not limited to the inspection of the final product, but permeates every key link from the source to the factory, following the principle of prevention first and whole-process monitoring. The starting point of the system is strict supplier management and raw material inspection (Incoming Quality Control, IQC). Qualification audits and regular assessments are conducted for suppliers providing medical-grade raw materials and packaging materials. Each batch of materials entering the factory must undergo sampling inspection, specification verification, and testing of key indicators (such as raw material purity, microbiological limits, packaging size, printing quality, etc.), and only materials that fully meet the standards are allowed to be admitted and released, preventing the entry of unqualified materials into the production line from the source.
During the production process, process quality control (In-Process Quality Control, IPQC) is implemented. Quality control personnel will monitor and conduct random inspections of the production environment (such as the cleanliness of a ten-thousand-class clean room), key equipment operating parameters, and semi-finished products in the production process according to the established frequency and standards. For example, checking the pH value and viscosity of the prepared gel liquid to see if they are within the control range; checking the accuracy of the filling volume; monitoring whether the parameters of the sterilization process (if applicable) meet the standards, etc. The purpose of IPQC is to detect and correct deviations that may occur in the production process in a timely manner, preventing the production of large quantities of unqualified products.
Outgoing Quality Control (OQC) of finished products is the last checkpoint before the product is released from the factory and the most comprehensive inspection. The QC laboratory of Pingchuang Medical will take samples and conduct inspections on each batch of finished product ultrasonic couplant according to detailed inspection procedures. The inspection items usually cover: appearance inspection (color, odor, properties, presence of foreign matter), physical and chemical properties (pH value, viscosity, sound speed/conduction performance), packaging inspection (sealing, label integrity, clarity of batch number and expiration date), as well as the crucial microbiological limit inspection (bacteria, mold, yeast, and for sterile products, sterile inspection and endotoxin testing).
To ensure the accuracy and reliability of the test results, the QC laboratory of Pingchuang Medical is equipped with advanced testing instruments and operated by trained and qualified inspectors. All inspection activities have detailed original records and inspection reports, ensuring traceability of the results. Only when all inspection items meet the preset quality standards and are approved by the Quality Assurance (QA) department can the batch of products be released for storage. Any product that fails inspection will be clearly marked, isolated, and disposed of according to the unqualified product handling procedures, and will not be allowed to enter the market.
The strict quality control system of Pingchuang Medical includes a comprehensive file management system (SOP, records, etc.), equipment calibration and maintenance plans, personnel training and assessment mechanisms, as well as a continuous improvement mechanism (such as deviation investigation, CAPA). The effective operation of the entire system is a solid support for ensuring the stable and reliable quality of each batch of ultrasound gels.
