On April 26, 2018, the State Drug Administration issued a notice stating that 'to guide the research on the compatibility of pharmaceuticals and packaging container systems, to establish and improve the guiding principles system of drug and packaging compatibility research, and to organize the development of Technical Guidelines for Compatibility of Drugs and Elastomer Seals (Trial)".
According to incomplete statistics, in 2017, China's pharmaceutical rubber plug field consumed about 50,000 tons of raw materials, with an annual growth rate of less than 5%. On the contrary, the annual growth rate of thermoplastic elastomer materials (TPE) in this area is as high as 15%. At present, the pharmaceutical packaging market in China is still fluctuating in raw materials, and the guiding principles for this release are to demonstrate the vigorous development of new materials in various fields of pharmaceutical packaging. In this 44-page document, specific highlights can be found. What sparked the waves?
Thermoplastic elastomers become the mainstay
The CFDA or the China Pharmaceutical Packaging Association has never previously published information on thermoplastic elastomer products in official documents. This shows that although this document is a trial, it has profound implications for the material application trend of the entire industry.
Based on the use of raw materials, this document systematically classifies thermoplastic elastomers into styrenes, polyurethanes, polyesters, and polyolefins by methods of preparation, chemical structure, etc. The TPE materials currently used in the Chinese pharmaceutical packaging market Including only the styrene block polymer-based blending system (ie, TPE-S) and blends of polymer elastomers and plastic dynamically vulcanized (ie, TPV).
Downstream medicine stopper accurate correspondence
In order to make raw material suppliers better connect with downstream companies, the principle of knowing also systematically divides different types of seals and even corresponding end pharmaceutical preparations:
This guiding principle focuses on the core indicators of thermoplastic elastomer materials in the production process and product performance.
According to rate statistics, in 2017, the pharmaceutical rubber stopper market, (halogenated) butyl rubber is still the leading raw material, accounting for about 70% of the total consumption of materials in the rubber plug field. Thermoplastic elastomers (TPE) accounted for It is only about 2%, but it predicts that it will maintain a growth rate of around 20% in the next 3 years.
It should be noted that the production capacity of domestic thermoplastic elastomer materials is not as expected, even though Dawn Polymers, with its strong development of TPE products, still focuses its pharmaceutical business on bromobutyl rubber. In addition, domestic adhesives The technical barriers of TPE materials for high temperature sterilization still limit its application.
However, from the perspective of downstream rubber plug manufacturers, the demand for thermoplastic elastomer medical seals is huge. After the existing TPE-S and TPV production capacity is mass-produced, the lower cost of raw materials brought about by the economies of scale, as well as the heat The cost savings in the production process can bring long-term economic benefits to downstream companies. It is worth looking forward to!