What appears to consumers as an ordinary personal lubricating jelly undergoes numerous "devil tests" like a pilgrimage to the West in a medical-grade factory. In today's increasingly stringent regulatory environment, compliance is no longer a simple paper promise but is reflected in every "devil test" from raw material entry to finished product shipment.
First is the rigorous screening of raw materials. All incoming medical-grade raw materials must undergo infrared spectroscopy analysis and heavy metal residue testing to ensure their purity meets national Class II medical device standards. After entering the production phase, environmental monitoring becomes even more extreme. In a 100,000-grade dust-free purification workshop, airborne particulate matter and microbial settling plates must be monitored daily to prevent any cross-contamination. During the semi-finished product stage, repeated calibration of physical and chemical indicators such as pH value, viscosity, and refractive index is to ensure that the product maintains perfect skin feel stability under different storage conditions.
The most critical step is safety validation. Compliant lubricating jelly must pass three core biological evaluations: skin sensitization test, vaginal mucosal irritation test, and in vitro cytotoxicity test. Only when all these data show negative or extremely low values is the product allowed to be filled. Before finished products leave the line, they must undergo accelerated aging tests to simulate shelf life performance under extreme storage conditions. This series of seemingly lengthy testing chains, although increasing production costs, serves as the strongest "bulletproof vest" for brands, ensuring that products can withstand any spot checks in market circulation.
PINGCHUANG Medical establishes and implements 21 stringent quality inspection procedures, relying on its 16,000-square-meter modern factory and GMP production standards, ensuring that the birth of every lubricating jelly is scientifically validated. As a professional OEM enterprise possessing Class II medical device registration certificates, FDA, and CE certifications, we provide full-process compliance endorsement, allowing clients to save millions in certification fees while enjoying medical-grade production quality and achieving safe and stable brand operation.
