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Equipment will develop in two major directions: specialization and versatility.
Release time：2016-08-18
Equipment It will develop in two major directions: specialization and integration.
With the advancement of technology, China’s pharmaceutical industry has made rapid strides, and many pharmaceutical companies have begun actively expanding into overseas markets. However, at present, Chinese pharmaceuticals still lag considerably behind the goal of “Made in China” innovation. To elevate the Chinese pharmaceutical industry to a higher level, critical equipment for ensuring sterility must be continuously refined in terms of hardware configuration, software control, and documentation systems, thereby providing robust technical support for domestic pharmaceutical firms as they strive to compete on the global stage.
In the future, the pharmaceutical industry must make concerted efforts to foster independent innovation and enhance its innovative capacity during the 13th Five-Year Plan period. Equipment—essential support for the pharmaceutical sector—must also be developed with a strong emphasis on innovation to deliver products of uncompromising quality. Experts suggest that future equipment development will likely trend in two directions: specialization and integration.
“Specialization” refers to the provision of comprehensive functionality; particularly in settings with stringent aseptic requirements, equipment must account for every potential factor that could compromise sterility and thereby ensure robust aseptic assurance. For items such as medical instruments and sterile gowns, “specialization” is manifested in maintaining a contamination-free environment and preserving post-sterilization sterility; for parenteral nutrition solutions like fat emulsions and amino acid preparations, it is reflected in antioxidant protection of the pharmaceutical products.
“Integration” means that the device is no longer a standalone piece of equipment, but rather a processing system equipped with auxiliary functions. In addition to its primary functions, it can also perform cleaning, leak detection, drying, and dehumidification; moreover, it is capable of treating not only ampoules but also instruments and garments.
China’s pharmaceutical industry is large in scale; to refine and strengthen the sector, in addition to R&D innovation by pharmaceutical companies themselves, the specialization and versatility of pharmaceutical equipment are of paramount importance. As critical equipment for ensuring sterility, such devices must be continuously optimized to eliminate all factors that could compromise aseptic conditions, thereby guaranteeing sterility.
This is a critically important step in the production of sterile pharmaceuticals. As regulatory requirements for pharmaceutical manufacturing continue to tighten, pharmaceutical companies are placing increasingly stringent demands on equipment piping configurations. For example, this includes the selection of sterile filters for compressed air within cleanrooms, as well as the implementation of dedicated CIP and SIP procedures; requirements for eliminating dead legs in piping design; independent sealing of double-door isolators’ seal doors; the replacement of threaded valves with flanged valves; and the use of hygienic-grade pipe fittings. In light of these considerations, equipment must excel in two key areas: specialization and versatility.
With the development of China’s manufacturing industry, several domestic equipment manufacturers have acquired advanced machining and inspection equipment to ensure the quality of component fabrication. For instance, to guarantee the welding quality of the reactor vessel and the sealing doors, Xinhua Instrument Co., Ltd. has adopted robotic welding technology. In addition, to more effectively inspect the welds in the reactor piping, Xinhua also employs endoscopic inspection instruments.
With the development of China’s pharmaceutical equipment industry, domestic equipment has made substantial progress in both technology and quality. The range of equipment has become more comprehensive, and product classifications more refined; however, compared with developed countries, Chinese equipment still lags behind, particularly in software systems. In terms of the stability of equipment performance, Chinese products remain somewhat short of the advanced international standards. For instance, some manufacturers, driven by cost considerations, typically equip their control systems with low-end industrial PLCs—yet the control system is the very core that ensures the stable operation of the entire piece of equipment. To achieve greater performance stability, companies must further enhance and refine their control software.
To drive innovation and upgrading in the pharmaceutical industry and develop more and better originator drugs, first-to-market generics, traditional Chinese medicines, and novel dosage forms, the State Council Executive Meeting held after this year’s Spring Festival made advancing such innovation a key priority. However, as the saying goes, “Even a skillful cook cannot make a meal with no rice.” R&D also requires state-of-the-art pharmaceutical equipment; as one of the critical components of the manufacturing process, only by achieving both specialization and versatility can we ensure foolproof operations at every stage of drug production.
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