The pharmaceutical industry's exploration of continuous production and manufacturing has never stopped. As early as the early 1990s, Germany had a registered patent for continuous granulation and continuous drying. Then there are online cleaning and online sterilization technology to ensure the transition of pharmaceutical production to online.
At present, many high-tech and methods can better link the pharmaceutical production process, such as online control and monitoring methods, integration technologies, etc., to promote the continuous manufacture of drugs. In addition to the processes and technologies mentioned above, the rapid development of pharmaceutical equipment is also driving the continuous production of the pharmaceutical industry.
For example, mixers used in continuous processes, in general, mixers used in continuous processes are small in size, not only suitable for the development of new products, but also for production. In addition, "the problems that are often difficult to amplify in batch operations are basically not going to happen here," said the mixer manufacturer.
Continuous production in the pharmaceutical industry begins with a reduction in complex cleaning steps and downtime for intermediates, while the size of individual equipment is reduced due to increased productivity. Experts said: "One of the advantages of using continuous production methods in the pharmaceutical industry is higher reliability and high cost efficiency."
In the case of tablet production, the final tablets produced by conventional methods are tested in an off-line laboratory after all operations have been completed. Whereas tablets requiring the same operation are continuously manufactured, the materials and products between each unit operation are passed uninterruptedly through the design of the pharmaceutical equipment and the control system.
“There are outstanding operating procedures and results, such as materials, products can continue to flow between each unit operation, real-time monitoring during production, fine tuning of the entire process based on online test results and evaluation, actual production time is equal to A few minutes to a few hours, etc.," the industry said.
Although the rapid development of pharmaceutical equipment has brought convenience to the continuous production of the pharmaceutical industry, in the context of product characteristics and unique environment, the pharmaceutical industry is still less advanced than other manufacturing industries, and processing and control technology is a big problem. .
Not only that, not all active ingredients and excipients are suitable for continuous process production, and the development of batch processes to continuous processes requires higher start-up capital – investment in pharmaceutical equipment, process analysis PAT systems and controllable systems. Etc. These tend to have higher economic conditions.
Therefore, experts suggest that pharmaceutical companies need to ensure the high quality of production and products with less waste, and actively research and innovate in continuous manufacturing. The author was informed that some pharmaceutical companies have studied the continuous manufacture of immediate release tablets.
In addition, pharmaceutical equipment companies cannot ignore the continuous production of the pharmaceutical industry. According to the analysis of relevant people, the technological innovation of continuous production in the pharmaceutical industry will bring about structural adjustment of the pharmaceutical equipment industry, and the focus is likely to gradually tilt towards the equipment industry, which is a great opportunity for pharmaceutical equipment companies.
At present, some pharmaceutical equipment companies are developing in the field of continuous manufacturing, such as pharmaceutical equipment companies to study the potential of continuous production of spray freeze dryers in the sterile core area.
Experts say that there is still much room for innovation in the continuous production of the pharmaceutical industry, because it can greatly shorten the supply chain, reduce the uncertainty and extra cost brought by the long supply chain, and can greatly reduce production time and shorten the production cycle. Of course, there is no need to enlarge the process, and the dosage form is designed to be flexible.
Therefore, for pharmaceutical equipment companies, continuous production in the pharmaceutical industry is both an opportunity and a challenge. In response to opportunities, pharmaceutical equipment companies need to improve their technology, increase their R&D and innovation, and strive to be the pioneers in the development of continuous manufacturing; for the challenges, pharmaceutical equipment companies need to face up, treat them correctly, and use more new equipment and technologies to help the continuous production of the pharmaceutical industry.