180 billion drug machine market, aseptic filling equipment has great potential

　　Pharmaceutical Network Market Analysis: In recent years, aseptic filling technology and equipment are beginning to play an increasingly important role in the pharmaceutical industry, especially in the biopharmaceutical industry This is mainly because in the production of drugs, pharmaceutical equipment can be in direct contact with drugs, its quality and safety will directly affect the drug Aseptic filling is a new packaging method carried out in asterical environment, which can better guarantee the quality of medicines
It is understood that, as a new packaging method, GMP requires that the filling of sterile drugs should be carried out in a class A environment, and on-line suspension particle monitoring and dynamic microbial monitoring (subsidence bacteria and plankton) This is mainly because it is essential for pharmaceuticals, especially biologics, to be filled into pharmaceutical packaging materials in a sterile environment, then labeled and packaged as finished drug products, so ensuring aseptic status is essential
As a carrier of aseptic filling technology, more and more pharmaceutical companies are increasing the demand for sterile filling equipment, especially many biopharmaceutical enterprises, but also began to seek higher technology aseptic filling equipment and systems to meet production needs
The author learned that in order to meet the high demand, there are already a number of enterprises have introduced robot technology into aseptic filling equipment and systems, and achieved certain results As recently, a global biopharmaceutical technology platform company announced that its preparation four plants (DP4) robot sterile biologic filling line at a rate of 30 bottles per needle per needle, has successfully completed two batches of pre-filled needle filling, and the pass rate of up to 99.1%
It is reported that this filling line with the full use of robot filling isolation device in the closed system, gloveless isolator and human intervention, can achieve high stability of filling accuracy and excellent level of aseptic protection, and delivery of high-quality preparation products Its related person in charge also said: "modular, automated, closed represents the innovation trend of biological agent production, its forward-looking application of robotic aseptic biologic filling line to build a variety of high-quality filling capacity, can better meet a variety of filling needs, to support customer products to market as soon as possible."
In fact, in the fierce market competition, modular, automated, closed design can indeed bring great benefits to enterprises The modular aseptic filling system can be further expanded quickly to suit different needs At present, there are also many sterile filling equipment enterprises in this direction to increase research and development innovation capabilities
For example, some enterprises have made some innovative modular designs for sterile canning systems in accordance with GMP specifications and aseptic process requirements Through modular design of "black and white partition", so that the filling part in the C-grade background of the A-grade layer flow area, BFS process in the A-class wind protection under the same station completed, and in the clean production area and ordinary production area also set up a control screen can switch to each other In this way, during the production period, no operator is required in the filling room, the product in the clean outdoor cutting, printing, testing, packaging, can be a greater limit to reduce the source of pollution between filling, more in line with the requirements of GMP and the production requirements of sterile drugs
Industry is expected to show that by 2020, China's pharmaceutical equipment market demand scale will exceed 180 billion yuan By then, as an important sub-sector of pharmaceutical equipment aseptic pharmaceutical production equipment, with the improvement and improvement of technology, will certainly usher in a good opportunity for development However, it is worth noting that in the case of expanding market, the pharmaceutical industry will be more and more demanding for sterile filling, many challenges are waiting for enterprises to solve, breakthrough Therefore, the relevant enterprises to ensure the quality of equipment under the premise, but also need to continuously enhance equipment performance, improve the level of equipment innovation.