In the fields of regenerative medicine and clinical treatment, the application of platelet rich plasma (PRP) technology is becoming increasingly widespread, and PRP separation gel, as the core material in the preparation process of PRP, its quality standards directly affect the treatment effect and patient safety. From no heat source control to specific gravity customization, each technical indicator carries strict requirements for medical safety. Understanding these quality standards is not only related to product quality, but also reflects a profound understanding of medical safety.

separation gel

No heat source: a basic requirement for medical safety

No heat source is the primary quality standard for PRP separation gel. Thermogen mainly refers to the lipopolysaccharides in the cell wall of Gram negative bacteria, which may cause a fever reaction or even more severe immune response when they enter the human body. In PRP treatment, any endotoxin contamination may affect treatment efficacy and endanger patient safety. The true requirement for no heat source not only includes final product testing, but also requires full chain control from raw material selection to production process. This requires enterprises to establish a sound quality management system to eliminate the risk of heat source pollution from the source.

Radiation resistance: adaptability of sterilization process

PRP blood collection tubes commonly use irradiation sterilization technology, which requires the separation gel to have good radiation resistance. During the irradiation of gamma rays or electron beams, the molecular structure of materials may undergo changes, and inferior separation gels may exhibit discoloration, performance degradation, or even decomposition. High quality PRP separation gel should be able to maintain stable performance under specified irradiation doses. After irradiation, the physical and chemical properties and biocompatibility of the separation gel should be maintained within the qualified range.

Hydrolysis resistance: Long term stability advantage of resin separation adhesive

In the PRP preparation system, the built-in sodium citrate or ACD anticoagulant comes into long-term contact with the separation gel, which imposes strict requirements on the hydrolysis resistance of the material. If the water resistance of the separation gel is insufficient, it is prone to swelling and softening in a liquid environment, which not only affects the separation accuracy, but also may release impurities that interfere with platelet activity. Compared to traditional colloids, resin separation gels maintain their physical integrity and specific gravity stability even after long-term exposure to anticoagulant solutions due to the stability of their cross-linked polymer structure, ensuring precise stratification of blood components.

Specific gravity customization: the key technology for precise separation

Different clinical applications have different requirements for platelet concentration and composition in PRP, which requires the separation gel to have the ability to customize specific gravity. By precisely adjusting the specific gravity of the separation gel, precise separation of different blood components can be achieved to meet diverse clinical needs. Specific gravity customization requires precise production process control, from raw material ratio to strict monitoring of the production process. Advanced production enterprises can provide customized proportion services within a certain range to help customers achieve better separation effects. This customization capability reflects the technological strength of the enterprise.

Full chain quality control system

To achieve these four key indicators, it is necessary to establish a sound quality control system. From raw material storage inspection to production process monitoring, from finished product testing to stability research, every link requires scientific quality control methods. Especially for the control of heat sources, high-sensitivity detection techniques are required. Enterprises should establish standards that comply with the medical device quality management system, and ensure the effective operation of the system through regular audits and continuous improvement. At the same time, it is necessary to establish a comprehensive traceability system to ensure that any quality issues can be traced back to specific links. This is not only a quality requirement, but also a medical responsibility.

Product packaging

Professional Manufacturing and Technical Support

In the field of medical grade separation adhesive manufacturing, Hubei Xindesheng Material Technology Co., Ltd. has established a sound quality management system with profound technical accumulation. Our PRP separation adhesive strictly adheres to the standard of no heat source and uses advanced production technology to ensure stable and reliable radiation and hydrolysis resistance of the product. Xindesheng has a professional R&D team that can provide customized services based on customer needs to meet the separation requirements of different clinical applications. Welcome to visit and inspect.