With the continuous development of technology and market, the development of any industry is approaching towards lowering the cost of construction and production, and the pharmaceutical industry is no exception. From the current point of view, the pharmaceutical industry is advancing at a high speed, light asset investment, multi-variety production, and a fast, compliant business model, catalyzing the birth of disposable process equipment.
The pharmaceutical industry is a relatively complex field, especially the research and development process, which takes a long time and costs a lot. But the emergence of disposable process equipment has helped pharmaceutical companies significantly reduce their R&D and production costs. So what is a one-time process equipment?
Disposable process equipment is a device that can be directly used and disposed of, eliminating capital investment and development time, and verifying the process of cleaning and disinfection. Increase time-to-market by removing verification steps and eliminating the downtime required to perform process steps between batches, thereby increasing productivity.
Take the application of disposable process equipment in the biopharmaceutical industry as an example. The author understands that disposable process equipment includes single-use bioreactors, disposable sensors, single-use ultrafiltration and refined purification technology, single-use virus inactivation and removal technology, and single-use aseptic connection and disconnection technology. , disposable liquid storage, etc.
According to relevant experts, these disposable process equipments have been cleaned and verified for direct use, reducing cleaning and verification processes, saving time, reducing equipment footprint and manpower. “In the case of serious drug safety problems, disposable process equipment has actually brought great help to pharmaceutical companies.” Industry experts said that in the production of different varieties, disposable equipment does not have the problem of cleaning to avoid cross-contamination, and It is easy to move. In addition, the products produced do not require additional container replacement, which reduces the possibility of contamination.
As another example, in the manufacture of cytotoxic agents, there is a risk of operator exposure during manual cleaning, so many pharmaceutical companies desire a one-time use as a means of handling contaminated equipment, minimizing operator exposure. Another driver is the sensitivity of some protein-based drugs to metal ions, leading some companies to look for alternatives to metal equipment.
From this point of view, disposable process equipment can indeed save money and development time for pharmaceutical companies, verify the process of cleaning and disinfection. In addition, a senior marketing specialist for pharmaceutical equipment companies said: “Recent trends and research have shown that people need to simplify the design and use of disposable process equipment and accessories.”
But in the past, the scope of application of disposable process equipment was not large. “Because disposable process equipment technology and systems are not as comprehensive as traditional production process technology,” experts say, however, more and more disposable process equipment and components are catering to the actual needs of pharmaceutical manufacturing processes. For example, diaphragm valves, which have been developed and put into use, have innovative technologies that have solved many of the limitations of traditional production processes.
In addition, disposable process equipment and technology can also make the production environment of pharmaceutical companies more flexible. The author was informed that during the process design, the single-use device made subsequent experiments change the system configuration easier, faster, and cheaper. For established processes, because single-use systems can be built, used, and discarded, it is easier to change processes in a multi-product facility, making the device more flexible.
Overall, disposable process equipment has great advantages in linear supply chain, increase in production capacity, cost performance, and cost reduction. With the growth of the market and the constant changes in industry demand, the one-time process equipment technology must also keep pace with the times and continue to meet market demand. In addition, relevant enterprises should also actively innovate in light of market demand, and help pharmaceutical companies reduce the cost of cleaning and sterilization, maintenance and labor costs.
