The only way of modern medicine industry
With China's formal accession to the WTO, China's pharmaceutical industry is facing the production and management practices must gradually with international norms, the product must be gradually moving towards a broader international market situation, the face of fierce international market competition and the production of drugs increasingly high quality requirements of China's pharmaceutical industry, many entrepreneurs feel more and more of China's pharmaceutical industry, production methods, quality control methods, business management and automation of production and management level of backwardness. Especially in recent years, some pharmaceutical manufacturers in China due to lack of strict and effective automated control and management tools and mechanisms, and thus the frequent occurrence of major drug production and quality accidents, leaders at all levels of China's pharmaceutical industry, drug quality supervision departments and enterprises home are increasingly aware of automation and information technology is the only way to achieve the modernization of China's pharmaceutical industry.
The diversity and specificity of the pharmaceutical industry automation
At present, China's pharmaceutical industry is mainly divided into the raw material drug production and drug production, bulk drugs and formulations including the type of chemical pharmaceutical, biotechnology, pharmaceutical and Chinese medicine. Different types of pharmaceutical, its form of automation is not the same, especially in bulk drugs and formulations, its automation is almost a completely different way. Although the pharmaceutical industry, the production of bulk drugs unit equipment and processes, in part, with the chemical production of similar (especially in the chemical and pharmaceutical), while not exactly the same (especially biological, pharmaceutical and Chinese medicine) but the petrochemical industry may be involved control theory, and methods and strategies are useless In fact, all the pharmaceutical field, and some automation problems rarely encountered in the field of petrochemical (for example, involve the problem of microbial growth and metabolism in the fermentation process automation; Chinese medicine extract concentration, ethanol precipitation, percolation process automation; computerized system validation issues). The pharmaceutical sector in terms of high temperature, high pressure did not like the petrochemical field, then the general requirements of fire and explosion prevention requirements also exist, and has a more stringent regulatory requirements in sterile, purification, sterilization, cleaning, etc.; real-time detection and analysis of the composition and quality, small amounts of real-time online testing of weighing and foreign and security recognition technology has a very urgent needs. To this end, the so-called PAT (Process Analytical Technology) and RFID (radio frequency identification technology) has become the two hot topics of the foreign pharmaceutical field.
Up to more than 3000 kinds of various types of pharmaceutical equipment and machinery, according to national standards (GB/T15692) can be divided into raw materials, preparation, grinding, Pieces, water, packaging, testing and supporting eight categories, which is the broadest range of preparation equipment have tablets, injection, powder, water injection, capsules, infusion, pills, oral liquid, emulsion, suppository, aerosol, drops and syrups, etc. as much as 14 kinds, but most of these devices has reached a considerable degree of automation and mechatronics degree. Many of the advanced automation technologies and tools (including a variety of light, mechanical, electrical, magnetic, gas sensing technology, testing technology, transmission technology, sports, technology, analytical techniques, a variety of PLC, the PAC, microcontroller, embedded technology, the bus technology, etc.) have been widely used on these devices can be described as automation technology, "the 18 martial arts, pharmaceutical equipment is everything.
Characteristics and content of the raw material drug production automation
Petroleum, chemical and other fields of modern large-scale, continuous, pipe production, the production process of pharmaceutical raw materials in China (especially in the biopharmaceutical and traditional Chinese medicine), which is basically a small-scale unit of mass and intermittent modes of production. In China, the application of automatic control systems is also limited in some of the local unit of raw material drug production and auxiliary systems (such as antibiotic fermentation; Chinese medicine extraction, concentration and separation; reaction, extraction and separation of the chemical and pharmaceutical; line disinfection and cleaning; boiler, etc.). Although common in the domestic pharmaceutical industry to some simple, independence and the unit of the PID control or program control mode, but in fact they do not represent the ideal for the pharmaceutical industry really wants to control mode, control (Batch Control) and approved management is the best control and management mode, the control system would be preferable to the continuous control of the analog switch logic control closely integrated batch control structure model, the control software should comply with IEC6113-3, IEC-61 512 / ISA-the S88 and 21 CFR Part 11 and other international standards and norms. In addition, automation equipment and process equipment is relatively small due to the volume of production equipment in the pharmaceutical industry regulatory touch in the production process automation, reflected much greater investment than the petrochemical industry; the pharmaceutical industry, intermittent production mode, the number and cost of the automation of investment required to achieve bulk drugs in the automated valves, actuators and related quite large, which one of the greatest resistance in China to achieve the transformation of traditional medicine industrial automation . In addition, China's pharmaceutical production process, many drugs, the physical properties of the content and quality indicators is still being difficult to use appropriate means and the number of standard on-line detection (especially traditional Chinese medicine), some production units and process control object properties. detection method and control program, pending further research and exploration; Therefore, the pharmaceutical industry in the original process and equipment conditions, the full realization of highly automated, does still exist to a certain degree of difficulty.
Preparation of production automation features and content
At present, producing the bulk of China's preparations basic is in the form of these mechanical and electrical integration of stand-alone group or multi-unit pipeline, although the degree of automation and reliability of mechatronics unit equipment is already high, But the solution to the problem of pipeline automation of these units by domestic and foreign equipment suppliers, between these units are mostly off from most of the domestic preparation equipment does not yet have a complete network communication functions, without taking into account electronic records and electronic signatures 21CFR Part 11 regulatory requirements; automation of the entire preparation of the production process have not been well integrated; preparation workshop automation design is mostly confined to the air conditioning and cleaning (HAVC), pharmaceutical water cleaning / sterilization (CIP / SIP) and combustible fire alarm interlock and other auxiliary systems supporting design; agents in the production process, raw materials, intermediate goods, semi-finished products to the final product logistics, transit and put most of them or artificial; most of the quality and measurement of control points also to the lack of suitable on-line monitoring means. Therefore, I personally think that the preparation of the production process automation work is not nothing to do, but should be plenty of opportunities. In my opinion, to study how strict accordance with the GMP, cGMP requirements, the use of advanced information technology and automation technologies (including PAT, RFID technology, logistics and automation technology, air transportation technology, and automated guided vehicle AGV technology, Industrial Ethernet and wireless network technology), the establishment of an integrated, comprehensive, real-time operation of the pharmaceutical production and quality management and automation systems, and to lay the foundation for truly established in the pharmaceutical industry MES system and ERP system, medical and industrial automation one has the great significance of the content. In fact, we have now started the process of drug production in exploration and preparation of the work in this regard.
Three aspects of the pharmaceutical industry automation project quality
Many of our design and automation projects, most of the first commissioned the Design Institute of the construction side, after the design is completed, commissioned by the construction side of the bidding company or building side directly to the engineering company to tender, engineering company made to the tender implementation of the project the right. This process in the actual implementation, but often there are many serious impact on the design and implementation of quality links, thus seriously affecting the quality of China's pharmaceutical industry automation engineering, for example:
Design aspects
Part of the design unit may be due to the object properties of some of the production process a deep understanding of, or out to reduce the consideration of design work, often only the design part of the control test points, while the control scheme, or the control scheme is not reasonable, often require rely entirely on their own to fill the engineering firm or user, especially in the control of the computer control system design and application software development. Ability and level of engineering design is often very limited, engineering design and implementation of the separation, the separation of hardware and software system design system design approach, has actually become an important factor seriously affect the quality of control system design. In addition most of the design automation design units are often more conservative, the lack of innovation.
Bidding links
The form of project bidding should have been a scientific, fair and open selection and optimization process, but the bidding for some projects in China actually is a mere formality, the bidder is often time and conditions did not understand the conditions of the project's process equipment. so-called bidding scheme are often not the basis of reasonable technical solutions; the bidding of the project evaluation process, often overlooked on the bidder's technical programs, control programs and equipment selection, economic and technical rationality, but attention to the tender price of the bidder and relationship. This bidding, not only lose the original significance of the project bidding, and often become the hidden dangers of the future affect the quality of projects at the same time, this bidding, the most tender side, often a costly process.
Project implementation link
Part of the engineering firm on the one hand in the bidding for competitive implementation of the project the right was forced to strongly suppress the tender price, on the other hand the implementation of the right, in order to compensate for the loss of interest and not by the quality and quantity and reasonable equipment, materials selection and implementation of the project, which has also become an important part of the serious impact on the quality of the project.
Summary
To do a good job in the pharmaceutical industry automation design and implementation, according to our practice and experience, it is recommended that the focus on the following questions:
Automation must have a clear purpose.
That is, whether it is design automation or automated transformation should not be to the automation of automation; can not engage in the basket case and showy. Must be to ensure that achieve remarkable results automate drug quality and safety, or economic benefits, or technological progress, or in the corporate management level.
Must pay attention to "reliable" and "practical" and "reasonable economic and technical" and "advanced" four principles.
Automation system design or automation equipment selection must pay attention to these four principles must be soberly aware that the reliability of the automatic control system design is the first for a production enterprise; automatic control system design of practical is all to the actual needs of the enterprise and practical in the future direction of development for the purpose of automatic control system design, economic and technical rationality, an important factor in determining an automated engineering design quality; the advanced nature of the automatic control system design must under the premise of the "reliability" and "practicality", "economic and technical rationality", to be creative, dare to explore, be good at home and abroad according to the actual situation of Chinese enterprises, bold introduction and application of advanced technology, ideas and experience.
Must pay attention to the study of the controlled object, automatic control strategy and program design and development of application software.
The task of the automatic control system design is based on the requirements of the production process and the characteristics of the controlled object, to establish the correct automatic control strategies and programs, according to various aspects of constraints, a reasonable choice selection of automatic control systems and equipment, constitutes a reasonable control system hardware architecture, application software design and development, and ultimately achieve the desired control objectives. Here, the automatic control strategies and self-control design is the most important, and automatic control strategies and programs is building in-depth understanding of the controlled object based on. The same time, the control system hardware system design and application software development and design combining. Otherwise, the so-called automatic control system design can not be reasonable and sound.
Must be based on the technology, equipment needs and ability to invest in the actual design of the project content, level and the level of rational planning and positioning.
Must recognize the right automation system design and planning programs should be built on at the same time must have the right technology, equipment design and process equipment needs based on certain financial conditions realistic. According to this principle, and the construction side and jointly improve project planning and positioning work. An automated design program must rely on the project process, equipment, management and self-control professionals work closely with a full discussion and communication, in order to jointly implement. Automated system design, to avoid a vacuum.
Must pay attention to the GMP and GAMP regulatory requirements, the automation must be closely integrated with information technology and pharmaceutical quality management.
Must clearly understand the many legal regulations in the pharmaceutical industry, automation professional is equally effective, although present, China GMP standard automated instrumentation and automation systems is still quite weak, but we must conscientiously study and understanding of GMP , cGMP principle and consciously reference the specification requirements of the foreign GAMP and GMP cGMP principle guiding the work of our pharmaceutical industry automation, automation work and business information, as well as the quality of medicines management initiative to closely combine.
About
Tang Jiliang, Shanghai Institute of Pharmaceutical Industry Automation Instrumentation and control of a professional senior engineers, researchers, the People's Republic of China registered automation systems engineer (in ASEA), registered facility supervising engineer in the People's Republic of China, State Administration of Traditional Chinese Medicine electronic technological transformation of the traditional medicine industry members of the Group Shanghai Chemical Industry and Engineering Society of Chemical Industry and Professional Committee. In automation engineering research and system design work in the field of medicine, chemical industry for a long time. Over the years, already has undertaken and completed more than 20 research projects and engineering design projects.
