Medical Polypropylene Specifications and Grade Compilation

plastic resin for medical

1. Medical Polypropylene

Medical Polypropylene offers a wide range of applications in China, ranging from packaging for drugs and pharmaceuticals to the use of modified plastics in both disposable medical devices (such as infusion bottles, syringes, etc.) and non-disposable medical equipment (such as measuring instruments, surgical instruments, etc.).

In China, medical polypropylene is primarily used in the field of disposable medical devices, such as disposable infusion sets, blood transfusion tubes, syringes, etc.  In recent years, Chinese companies have intensified their efforts in the development of medical polypropylene products. Currently, there are domestically produced alternatives that can rival European and American products, providing more cost-effective choices.

The hygiene performance of regular polypropylene does not meet the standards for producing medical products. Currently, the evaluation of the hygiene performance of medical polypropylene in China is primarily conducted following the YY/T 0242-2007 “Polypropylene Special Resins for Medical Infusion, Transfusion, and Injection Devices” standard. This standard not only specifies the physical and mechanical properties of medical polypropylene but also sets technical requirements for its chemical properties and resistance to radiation.

Medical Polypropylene Standard

Medical polypropylene products are often sterilized using high temperature or radiation methods and require a certain level of resistance to aging. Therefore, stabilizers must be added before processing the products. In the industrial development process of dedicated resins for medical infusion bottles, the selection and dosage of additives must consider the requirements of medical hygiene standards.

Furthermore, according to the requirements of the medical resin leachable test, the phosphate content should be below 0.15μg, and the addition of phosphite-type auxiliary antioxidants should be prohibited during production.

In conclusion, in order to meet medical hygiene standards, catalysts and additives need to be given special consideration. Additionally, other factors that may lead to a decrease in hygiene performance should also be taken into account. For example, the final stage of drying in the drying unit should use high-purity nitrogen instead of circulating air as the drying medium; the additive feeding system should be thoroughly cleaned before and after production; and the blending air delivery system should regularly replace the filter cloth, among other precautions.

Non woven

2. Medical Polypropylene from China

In 2011, the High Flow Medical Transparent PP project undertaken by Yanshan Petrochemical Research Institute passed the evaluation of Yanshan Petrochemical and achieved stable production of high flow medical transparent polypropylene grades, K4925 and K4930. The comprehensive performance of these grades reached the level of similar imported products.

In 2012, Sinopec Zhongyuan Petrochemical developed a specialized material for the medical industry, PPR-MT20. This product is a medium melt flow transparent polypropylene widely used in the injection molding field that requires transparency, mainly for the production of medical needles.

In 2014, Northern Huajin Group successfully developed a new medical transparent PP product, RP344P-K, which also obtained certification according to the standard “YY/T0242-2007 Special Resins for Medical Injection, Blood Transfusion, and Infusion” in China.

In the same year, RP344P-K also complies with the regulations of the United States Food and Drug Administration (FDA), European Community REACH regulations, and the relevant provisions of the Chinese standard GB 9693-1988 for hygiene standards of polypropylene resins used in food packaging. It has obtained relevant certifications.

In 2017, Sino-Korean Petrochemical successfully developed GA260R, a random transparent PP resin that is resistant to radiation sterilization. They became the first petrochemical company in Asia to successfully produce radiation-resistant medical-grade polypropylene materials. This product can be used in the production of disposable medical injection syringes, needle caps, and other related products.

In the same year, the transparent random copolymer polypropylene product K4912 produced by Shenhua Coal to Oil Yulin Company passed the biological performance and chemical performance tests conducted by the Guangzhou Medical Device Quality Supervision and Inspection Center of the National Medical Products Administration.

In 2019, China Petroleum Dalian Petrochemical Company released the polypropylene products H39S-2 and H39S-3, which were developed and produced. These two PP products are high-end medical non-woven fabric production materials that meet import standards.

In June 2020, Sinopec Zhongyuan Petrochemical successfully developed and produced a new polypropylene product, PPR-MT25, primarily used in medical needle production.

In June 2020, the Ministry of Chemical Industry developed and produced the polypropylene flexible fiber material (PPR-Y35XB), which was first released. In September, the polypropylene transparent injection molding material (PPR-MT20-S) and polypropylene flexible fiber material (PPR-Y35XB) were recognized as green products by the China Petroleum and Chemical Industry Federation.

In September 2020, Luoyang Petrochemical successfully conducted the first trial production of antibacterial low-odor spunbond non-woven fabric specialized polypropylene resin, PPH-YJ40X.

In November 2020, Maoming Petrochemical’s No. 1 polypropylene unit successfully produced the PPB-MG20, a high gloss, high modulus, and impact-resistant polypropylene resin product for pre-filled syringes. Polypropylene products for pre-filled syringes have good rigidity, heat resistance, toughness, and transparency. They are widely used in the administration of insulin, human growth hormone, vaccines, and other liquid drugs in the pharmaceutical industry.

3. Conclusion

In recent years, significant progress has been made in the Chinese chemical industry in the development of medical polypropylene materials. Several petrochemical companies have successfully developed high-end medical-grade polypropylene products that meet international standards for the production of medical non-woven fabrics, syringes, and other medical products. Additionally, polypropylene materials with specific properties such as radiation resistance, transparency, and antimicrobial characteristics have also emerged.

As experts in the chemical plastics industry, our company, JHP Plastic, can provide you with superior solutions for medical polypropylene. We have extensive industry knowledge and resources to assist you in finding high-quality medical-grade polypropylene materials that meet your specific requirements. Our products can satisfy the stringent demands of medical products, including high flowability, radiation resistance, transparency, and antimicrobial properties.

We are committed to collaborating with our customers to deliver customized solutions, ensuring that your medical products achieve the highest levels of performance and quality. If you have any needs or questions regarding medical polypropylene materials, we are here to offer assistance and support. Please feel free to contact us, and let us work together to develop optimal solutions for your medical polypropylene requirements.

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