Views: 74 Author: Site Editor Publish Time: 2022-08-13 Origin: Site
What is the difficulty in replacing domestic imports of domestic medical implantable PEEK?
After 20 years of rapid development in domestic orthopedics, products have gradually broken the monopoly of foreign countries, but in terms of basic biomedical materials, some domestic materials are still stuck in the neck.
Medical implant-grade PEEK (polyether ether ketone) is such a material. In the past few decades, implant-grade PEEK materials have been monopolized by three global manufacturers, so that we have to accept foreign high-priced raw materials, even Some foreign brands of materials are not sold in the Chinese market, nor can they be purchased at high prices, and it is even more impossible to talk about the price reduction of centralized collection and belt volume.
Breaking through the monopoly of foreign medical implant-grade materials has always been the goal and dream of domestic enterprises. However, why it is difficult for domestic enterprises to break through the foreign blockade for so many years, after long-term research and summary, there are four main difficulties:
1. It is difficult to update production equipment and environment
At present, there are about 5 domestic manufacturers with industrial-grade PEEK polymerization production capacity, almost all of which have formed a mature industrial-grade PEEK polymerization process and equipment. Due to the early development of these PEEK enterprises, it is difficult to meet the production requirements of implantable PEEK in terms of production environment layout, production equipment, and related configurations.
Most domestic PEEK raw material suppliers do not have medical device production qualifications, and the relevant requirements and standards for implant-level production lines are not clear. At the same time, chemical companies are very cumbersome to change equipment and production lines, and there is a lot of financial pressure. It is necessary to explore and establish The cycle time for new production lines is very long.
2. The purification process of implantable PEEK is difficult
From the perspective of products, industrial PEEK and implanted PEEK have little difference in performance. The difference is mainly in the purity of the material. To ensure the biocompatibility of PEEK materials used in the human body for a long time, it is necessary to ensure the content of some trace chemical elements and heavy metal ions. Not exceeding the standard. At present, almost all PEEK produced by domestic enterprises have the problem that the content of trace elements and metal ions exceeds the standard.
At present, this problem can only be dealt with in the process of polymerization and refining, and it is difficult to remove even with high-pressure melt filtration after granulation. To solve this problem, PEEK manufacturers need to actively work with domestic equipment manufacturers to develop equipment that meets the requirements for the purification and purification of implanted PEEK, and to study new purification processes. Only by making joint breakthroughs in both equipment and process can we ensure the effective removal of metal ions and trace chemicals during purification.
3. The material process is difficult to comply with the regulations
Making a product is only the first step, and compliance with YY/T 0660-2008 and 16886 related implant materials is only the basic requirement. As a domestic head implant-grade PEEK material manufacturer, when submitting product registration, it will be strictly reviewed by the evaluation teacher, and the Food and Drug Administration will even conduct unannounced inspections of the entire production process. key process flow.
How to show the judges the stability and reliability of the process in the whole production process, and how to show the traceability in the whole production, processing and manufacturing process? These are all very important and difficult points.
4. Acceptance still requires a process
The acceptance and approval of domestic materials by government regulatory authorities, medical device companies and hospital doctors requires a process.
Jiangsu Junhua, as one of the earliest units engaged in the research, development and production of PEEK materials in China, pays great attention to the application of PEEK in the medical industry, and has been committed to the research and development and production of medical implantable PEEK materials.
After 16 years of production and technology sinking, the company started from the source of polymerization, established Shandong Junhao High Performance Polymer Co., Ltd., and polymerized and implanted PEEK raw materials by itself. In accordance with the production standards of medical implant materials, a GMP refining production workshop was established, and professional refining and purification equipment for implant-grade AKSOPEEK® polymerization was developed, which effectively solved the problem of excessive heavy metal ion content in implanted PEEK materials.
In order to further effectively realize the monitoring and traceability of the whole process, the company selected the DCS central control system, which can effectively realize the control and detection of the main parameters inside the equipment during the production process, ensure that the production process is completely controllable, and the production data can be archived separately to facilitate subsequent traceability.
In 2020, the company produced the autoclave implantation grade PEEK material. In the same year, a third-party test was carried out on the biology of the material in accordance with the ISO10993 test standard, and the test results all met the requirements.
In 2021, the first batch of mass-produced implant-grade AKSOPEEK® materials will be submitted for biological and physical and chemical properties inspection in accordance with YY/T0660-2008 medical industry standards. Record work.
Jiangsu Junhua Special Plastics detects metal ions by plasma metal chromatography (ICP), and the lead ion content is extremely low, less than 0.002%.
In addition to the basic requirements of the implantation grade, for the customers who use it, the focus is still on the mechanical properties of PEEK products. The quality of mechanical properties is related to whether patients can use it for a long time.
In response to the requirements of mechanical properties, Jiangsu Junhua Special Plastics developed high-toughness AKSOPEEK®, which guarantees the postoperative recovery of patients with performance far exceeding the index.
In addition, when we use implantable PEEK, there are also relevant medical industry testing specifications for some specific uses, and the representative one is the interbody cage.
Using the YY/T 0959 (ASTM F2077) test method for mechanical properties of spinal implants and interbody cages, under the load of 2000/4000N, frequency of 5Hz, and test times of 5 million times, the AKSOPEEK® Natural interbody cage was tested. (H is 6.3mm) for compression fatigue test, no failure due to fatigue occurred. The static test before and after fatigue did not show a decrease in strength, and the compression yield of this type of cage was only at 12000N.
Medical implant-grade PEEK (polyether ether ketone) is such a material. In the past few decades, implant-grade PEEK materials have been monopolized by three global manufacturers, so that we have to accept foreign high-priced raw materials, even Some foreign brands of materials are not sold in the Chinese market, nor can they be purchased at high prices, and it is even more impossible to talk about the price reduction of centralized collection and belt volume.
Breaking through the monopoly of foreign medical implant-grade materials has always been the goal and dream of domestic enterprises. However, why it is difficult for domestic enterprises to break through the foreign blockade for so many years, after long-term research and summary, there are four main difficulties:
1. It is difficult to update production equipment and environment
At present, there are about 5 domestic manufacturers with industrial-grade PEEK polymerization production capacity, almost all of which have formed a mature industrial-grade PEEK polymerization process and equipment. Due to the early development of these PEEK enterprises, it is difficult to meet the production requirements of implantable PEEK in terms of production environment layout, production equipment, and related configurations.
Most domestic PEEK raw material suppliers do not have medical device production qualifications, and the relevant requirements and standards for implant-level production lines are not clear. At the same time, chemical companies are very cumbersome to change equipment and production lines, and there is a lot of financial pressure. It is necessary to explore and establish The cycle time for new production lines is very long.
2. The purification process of implantable PEEK is difficult
From the perspective of products, industrial PEEK and implanted PEEK have little difference in performance. The difference is mainly in the purity of the material. To ensure the biocompatibility of PEEK materials used in the human body for a long time, it is necessary to ensure the content of some trace chemical elements and heavy metal ions. Not exceeding the standard. At present, almost all PEEK produced by domestic enterprises have the problem that the content of trace elements and metal ions exceeds the standard.
At present, this problem can only be dealt with in the process of polymerization and refining, and it is difficult to remove even with high-pressure melt filtration after granulation. To solve this problem, PEEK manufacturers need to actively work with domestic equipment manufacturers to develop equipment that meets the requirements for the purification and purification of implanted PEEK, and to study new purification processes. Only by making joint breakthroughs in both equipment and process can we ensure the effective removal of metal ions and trace chemicals during purification.
3. The material process is difficult to comply with the regulations
Making a product is only the first step, and compliance with YY/T 0660-2008 and 16886 related implant materials is only the basic requirement. As a domestic head implant-grade PEEK material manufacturer, when submitting product registration, it will be strictly reviewed by the evaluation teacher, and the Food and Drug Administration will even conduct unannounced inspections of the entire production process. key process flow.
How to show the judges the stability and reliability of the process in the whole production process, and how to show the traceability in the whole production, processing and manufacturing process? These are all very important and difficult points.
4. Acceptance still requires a process
The acceptance and approval of domestic materials by government regulatory authorities, medical device companies and hospital doctors requires a process.
Jiangsu Junhua, as one of the earliest units engaged in the research, development and production of PEEK materials in China, pays great attention to the application of PEEK in the medical industry, and has been committed to the research and development and production of medical implantable PEEK materials.
After 16 years of production and technology sinking, the company started from the source of polymerization, established Shandong Junhao High Performance Polymer Co., Ltd., and polymerized and implanted PEEK raw materials by itself. In accordance with the production standards of medical implant materials, a GMP refining production workshop was established, and professional refining and purification equipment for implant-grade AKSOPEEK® polymerization was developed, which effectively solved the problem of excessive heavy metal ion content in implanted PEEK materials.
In order to further effectively realize the monitoring and traceability of the whole process, the company selected the DCS central control system, which can effectively realize the control and detection of the main parameters inside the equipment during the production process, ensure that the production process is completely controllable, and the production data can be archived separately to facilitate subsequent traceability.