As the country's supervision of food and drugs continues to increase, the collection of production information and the supervision of market products have shown the same importance. It can be seen that the government regulatory authorities have increased their determination to regulate the production links of production enterprises. Then to ensure the effectiveness of its supervision, the production enterprise must improve the automation level of the product after the packaging, and adjust the production equipment in line with the management of the national first, second and third level supervision codes.
Due to the weak automation of the packaging of domestic foods and medicines, the technical content of complete sets of equipment is relatively low. The GMP certification implemented in the previous years of the country has not compulsory certification of outsourcing. In addition, the labor force in the past few years in China has been low, resulting in the vast majority. The rear packaging of the enterprise adopts the human sea tactics, and to change the backward packaging form, it is necessary to introduce advanced management mode and advanced automation equipment. Here, the author only talks about several development ideas from the complete set of equipment in the back channel.
1 small box after the definition of the packaging of the small boxed products to achieve the automatic packaging after the main refers to: automatic boxing → sorting (re-examination, gold inspection) → first-level supervision code → medium package (bundle, plastic package) → Secondary supervision code → stacking → packing, sealing → three-level supervision code → storage management → collecting information input calculation management system.
2 small box of post-package management requirements and procedures 2.1 small box of post-package management requirements boxed products refers to the unit carton packaging sales of a single body packaging form, mainly pharmaceuticals, food, health products, cosmetics, a small electrical appliances , small electronic products, hardware, etc. At present, in addition to the supervision code for drugs and foods, the state does not regulate other products. In many countries in Europe, as long as it is a boxed product, it must carry out the first, second and third level code supervision, mainly the embodiment of the enterprise's own management. Recently, I was informed that the State Food and Drug Administration has implemented code supervision on some products, especially the supervision of drugs, and I am very pleased.
The small box packaging is completed to the whole process of large-box packaging and storage. According to the different types of products, the specific requirements are not the same. Only the medicine box-packed products are taken as an example to introduce the requirements and procedures of the downstream management.
The form and specifications of pharmaceutical packaging are also ever-changing. Therefore, the management is relatively difficult, the equipment set is poor, and the linkage effect and information collection are difficult to achieve. At present, the domestic pharmaceutical small box packaging regulations: (1) the product has a production date, expiration date, product batch number; (2) printed product barcode (for sales management); (3) built-in product manual; (4) marked OTC and prescription drugs, There are no clear rules for the middle and big bags.
As the government tightens the supervision of food and drugs, the following changes will be made to the small box packaging products and their subsequent packaging: (1) Phase III (production date, expiration date, batch number); (2) Government supervision and management code (Unique code first-level code) (3) Built-in product manual; (4) Bar code; (5) OTC drug marked OTC; (6) Medium-level supervision code; (7) Number of packages; (8) Large The three-level supervision of the container must have the production date, batch number and quantity; (9) The big box must have two pieces of information (same information)
To meet the above management requirements, manual processing alone has a large amount of labor, a large increase in cost, low monitoring power, and confusion. In order to overcome the above drawbacks and to show the modern civilized production, it is extremely necessary to pay attention to practical, reasonable, efficient and high automation in the planning of the trails. The related equipment should have the characteristics of high automation and strong functions.
2.2 The process of packaging the small box after each package, each product, each product type is different, some small boxes are traditional tongues, some are in the form of glue, you can choose automatic cartoning machine boxing, manual boxing, and then packaging Manual boxing is a time-consuming and laborious process of Zui. Enterprises can plan the production with a larger output according to the output of the products. The carton (machine box) is packed in an automatic cartoning machine, because the cartoning machine is in the process of packaging. There will be problems such as “missing pages†or lack of materials, defective packaging, and foreign metal objects in the front road. Therefore, it is necessary to install a sorting machine in the back of the cartoning machine. The sorting machine can be divided into: online weighing detector, online metal detector, online imaging detector, and the like.
It can be installed according to the requirements of the product. After the small box packaging is selected, the qualified products are input into the next management process and the first level supervision code is sprayed and scanned, the unsprayed products are eliminated and the qualified product database is automatically generated. After completing the first-level code, the package is divided into: (1) the package in the carton; (2) the package in the heat shrinkage; (3) the three-dimensional package; and (4) the package in the bundle.
However, the above-mentioned medium-package forms have lower cost in the bundled package and the three-dimensional package, but the stability of the domestically produced such packaged equipment is still poor.
After the completion of the package, the company enters the secondary supervision code management system, and the material of the package is currently based on PVC type BOPP film, while the secondary code is generally printed on the paper, so the second code can be sprayed first. The form on the logo is then attached to the package. Therefore, to achieve automation, add a printing device on the labeling machine, online printing or online labeling to complete the input function of the secondary code. Based on the current boxing machine, weighing machine (or other sorting machine), medium charter, labeling machine, there is no difficulty in linkage, so it is easy to pack, sort, package, and supervise the code of the rear package. Automating, but there is still no such high-end equipment in China.
After the completion of the scanning of the secondary code, the domestic general enterprises are taking manual work. In fact, in the developed countries such as Europe and the United States, the road is basically mechanical automatic operation. At present, domestic automatic stacking, packing, sealing and other equipment are scattered. In order to complete this process, the front and rear sites need more than ten or twenty meters. The automation is too low, and the site is wasted. According to the enterprise site cost of RMB 3,000/m2, only the venue fee has already cost millions. However, at present, there are a variety of multi-functional box-opening machines in foreign countries, which complete the stacking, unpacking, packing and sealing functions within a short 3m. This one-piece machine is very suitable for medicines and foods. package. However, due to the lack of domestic manufacturers of this machine, many companies use a semi-automatic packaging line. The author believes that to change the backward packaging form, we should first select internationally advanced models, and then make necessary improvements according to the special circumstances of the country to form a medium-to-high-end packaging line suitable for domestic food and pharmaceutical companies.
In the rear packaging, the box-packing and box-packing machine is particularly important, and is also an important device for the first- and third-level supervision codes. The boxing machine should include automatic stacking, automatic unpacking, automatic boxing, automatic sealing, online printing three-level supervision code (two-sided simultaneous printing), automatic scanning detection, and all the subsequent packaging processes after Zui And complete data collection and data generation, and enter sales management.
3 small box of post-packaged equipment research and development ideas Since the return to China in 2009, the author has visited dozens of pharmaceutical companies, mainly to investigate the status quo of the outer packaging, I am gratified that many large enterprise groups and Sino-foreign joint ventures are very Pay attention to the construction and matching of the rear packaging. In the design of the new plant, the requirements for outsourcing design are higher. But what is regrettable is that a large part of enterprises pay more attention to the GMP workshop than the outsourcing workshop. In fact, this is a misunderstanding. The improvement of the degree of outsourcing automation is an effective way to directly reduce the cost of products. However, some design units in China have little understanding of the outsourcing roads, and often the processing of the downstream processes and equipment is too simple when designing the factory buildings. As a result, many enterprises have small outsourcing space and scattered sites. Once the construction of the plant and public works is completed, it is difficult to improve the outsourcing packaging space.
Since the large-scale GMP transformation has been carried out for 12 years, many enterprises have gone through the process of accumulation of original capital after more than ten years of efforts, and now they have embarked on the road of development. On the road to survival in development, how to reduce costs, reduce labor, and improve efficiency is something that every enterprise must consider. Therefore, transforming outsourcing automation will be one of many enterprise development programs. With the increase of labor costs, the strengthening of national supervision, and the improvement of quality requirements, the packaging will be mentioned on the agenda after the transformation. To renovate the rear packaging, management must take the international road, and the equipment requires linkage. Planning equipment is very important. At present, many manufacturers often use low-end semi-automatic equipment. In fact, such support often contradicts future development. The use of advanced equipment instead of labor is the business philosophy of many multinational companies. It turns out that the cost of automation is far lower than that of manual work, and the packaging of the latter is mainly the linkage of small bags, medium bags and big bags, and realizes computerized management.
3.1 Small box cartoning machine Small box packaging forms are various, and different types of cartoning machines can be selected according to the product. If the site allows, the variety is simple and the quantity can be large, the front device and the cartoning machine can be connected. However, the front-end equipment must solve the problems of lack of grain, defects, and lack of weight.
In China, the cartoning machine has medium and high speed, low speed, etc. The models are vertical and horizontal, and there are continuous and gap type. However, due to the short development time of the domestic cartoning machine, the stability of the overall model is not good. Looking at the characteristics of domestic front-end products, the speed of the domestically suitable models is 150-180 boxes/min and the length is about 2.5m, and the price is around 300,000. At present, due to the slow speed of the vertical gap and the complicated connection, it can only be used as a small variety of boxes, and should not be designed as the main product in the downstream packaging line. Although the horizontal continuous type can meet the requirements, the fuselage is long, the floor space is large, and the price is high. It is not suitable to be the main product in the rear packaging line. The medium speed machine zui is suitable, and it is ideal for the front and rear equipment.
The small box cartoning machine has a great relationship with the enterprise's packaging materials. Generally, the packaging carton must be machine-packed, 250-350g/m2, the specification cutter should be neat, and the weight is 50-60g/m2. In fact, many companies can achieve the requirements of paper, but the work can not be achieved, so the boxing effect is not satisfactory.
3.2 The sorting machine and the first-level code equipment The second part of the packaging equipment is the sorting machine and the first-level supervision code. There are many domestic and international brands in the sorting machine, mainly due to inconsistent precision. International brand products have high precision and stability, and domestic products have certain advantages in price/performance ratio. From the market survey, the sorting machines are generally mature.
The supervision code equipment was first introduced in China, with high technical requirements and strict requirements for system construction. At the same time, the state has specific regulations on the entry threshold of systems and equipment. Therefore, the system software of the first level supervision code is very important, and the supporting equipment is generally sprayed. The printer is mainly used, but the traditional inkjet printers are all oily inks, which do not meet European environmental standards. The laser printers are slower and produce smoke, and have requirements for small box printing. Water-based inks are ideal. Environmentally friendly and cheap.
After the scan data of the supervisory code is completed, a reject device should be installed to remove the unprinted small box, which is simpler.
3.3 The traditional package in the package is mainly in the carton package, generally 2 to 20 small boxes as a unit, and the packaging forms are various; until the late 1990s, the domestic heat shrinking instead of the carton was used to reduce Cost and increase the level of automation. However, the heat shrinking equipment has certain defects, high energy consumption, high temperature to the environment, and high running cost. However, due to the simple technology and stable operation of the heat shrinking equipment, many companies are still using it. Nowadays, low-carbon energy reduction is advocated all over the world. The advantages of this type of equipment no longer exist. Instead, it is bundled and transparent film packaging; because the running cost of bundle packaging and transparent film packaging is lower than the heat shrinkage, and the operation is not Producing high temperatures and low power consumption, many companies are gradually accepting such equipment, and consumers in the market are beginning to favor bundled packaging and transparent film packaging products. Since the domestic strapping equipment and transparent membrane equipment are on the market in the 1980s, they are very complicated in maintenance and adjustment. It is time-consuming and costly to use, especially in maintenance and repair. Nowadays, advanced foreign models adopt the design principle of separate operation and maintenance, which is convenient for operation, does not produce dead ends, and is more in line with GMP.
Since domestic equipment manufacturers put price competition in the * position, they often adopt ways to reduce costs and configuration, while foreign advanced models are very high in processing accuracy and configuration requirements, and some domestic manufacturers are far from being able to match. Its business philosophy is also that the price is not good, and the result is often the use of enterprises. At present, the advanced foreign models are all in accordance with the design concept of servo system control, mechanical and pneumatic coexistence, operation and maintenance, which makes the equipment stable in operation, simple in maintenance and debugging, and the only shortcoming is that it is compatible with existing equipment in China. Than, the price difference is too much.
3.4 The combination of the second-level code device and the second-level code is not the same as the one-level code. The small box is a paper box, and the printer can print directly, as long as the corresponding position is left. However, the material of the middle package is generally a PVC type BOPP film, and the characters sprayed on the surface are easily wiped off. For automation, the ideal method is to match the labeler to the printer (Figure 4). The labeling speed of the package is slow, the requirements for the labeling machine are not high, and the technology of the domestic labeling machine is quite mature, and the general domestic labeling machine can meet the requirements (this is the place where the author is very pleased). Install the secondary spray dock on the labeling machine, so that online coding and online labeling can be done, and the secondary code printing process can be completed. At the same time, the scanning detection is installed at the exit of the labeling machine to complete the data. collection.
3.5 Large and third-level code equipment is relatively complicated to complete the package to the big package and the third-level code. First of all, from the analysis of the equipment, the current domestic drug package format and specifications are not the same, some do not need to pack large boxes directly, some of the different forms of the package, and some of the large box opening direction is inconsistent, resulting in automation difficulties Larger, this requires large-capacity equipment to be fully functional, adapt to multiple varieties and specifications. However, according to the current domestic line, the waste is too large (mainly waste of the site), and the maintenance is very troublesome, and there are more operators and support personnel. With the implementation of the three-level supervision code and the further improvement of the labor law, it is extremely necessary to have a small equipment with a small footprint, adaptability and full functions.
At present, the more popular equipment in Europe is the one-packing machine, which is a single unit that integrates automatic stacking (can be packaged, can be small), automatic unpacking, automatic packing, automatic coding, automatic sealing and automatic scanning. Equipment, and a wide range of adaptation, the direction of the opening can also be adjusted, the entire equipment operation requires only one person, because of the wide range of packing sizes of such equipment, the electrical configuration requirements are also high, especially the track processing accuracy is very strict . Here we explain that our domestic processing level is actually very good. Many products of professional manufacturing enterprises are exported to Europe and the United States. The authors in Germany serve more than 60% of the products on the products from Shanghai, China, and the quality of the products has always been It is more stable, but these companies only do processing trade. If they have the ability to develop technology, then our country is fully capable of doing * packaging equipment.
In the process of loading a large box, the print head should be installed on both sides of the large seal and printed at the same time, and the scanner is installed at the exit, so that the entire three-level supervision code is completely combined with the automated rear-end packaging, and the system is Construction, all input into the computer management system, can provide raw data for enterprise production management, warehouse management, and sales management.
The intelligentization of 4 small boxes of rear packaging equipment improves the intelligence of small box packaging equipment, mainly reflected in the combination of high-tech electronic products and machinery, commonly known as light, machine, electricity and gas. Detection means the level of product qualification rate, such as metal detection, stereo imaging detection, weighing detection, supervision code detection, etc., all of which are applied today's advanced sensors. With the continuous improvement of people's product quality requirements, the improvement of the company's own management, the improvement of the process requires equipment renewal, high-tech equipment will promote the improvement of the process, especially the GMP emphasizes traceability and descriptiveness, so the small box The intelligentization of the final packaging equipment is a prerequisite for quality assurance.
At present, the domestic pharmaceutical small box rear packaging mostly stays in the developed countries in the 1980s, and the modernization and standardized production requirements are in line with the international standards. This requires equipment to go to high-tech roads and apply high-tech electronic equipment and electrical equipment. In the European countries, the AQAI management system was promoted in the 1990s. AQAI requires automatic quality assurance and inspection data on the equipment to improve the pass rate. Since the next package of the rear packaging is the storage and market, it is directly facing the consumers. Without accurate and reliable equipment guarantee, it is difficult to control the traceability and descriptiveness of the process. In the actual sales process of pharmaceuticals and foods, once a quality accident occurs, the state has a greater penalties and its claims are quite high. Therefore, it is required that the downstream equipment should have intelligent detection and monitoring of AQAI, so each equipment should be considered in the design of new technology. The application of new technologies and new materials, especially the combination of mechanical and electronic information and testing instruments, is very important for real-time collection of production data processes, and truly becomes an intelligent machine integrating light, machine, electricity and gas.
The intelligence of the small box packaging equipment often reflects the application of servo, the combination of microcomputer and microelectronics, and at the same time cooperates with the related technology of the detection system, so that the data transmission system between the devices in the downstream packaging is relatively perfect.
The key control points for the back packaging of the small box are blister packs, for example, the following: the lack of grain detection of the medicine board, the damage detection, the number of tablets into the box, the detection of the manual, the specification or not Printing detection, cartridge tongue detection, cartridge weight detection, first-level code detection scanning, medium-package stack detection, medium-package integrity detection, secondary code detection scanning, weight detection, large-box stack detection, three-level The code detection scan scans the small package, the middle package and the large package. The detection points should interact with the entire rear packaging computer management system. The back-end computer management personnel can remotely monitor the data of each process and analyze the causes and production. The operator can also know the usage of the equipment in time through the human-machine interface, and truly realize the efficient and intelligent management of the subsequent packaging.
5 Conclusion This article starts with the definition of the packaging of food and medicine small boxes, describes the management requirements and procedures of the small box packaging, discusses the research and development ideas of the complete packaging of the small box packaging, and focuses on the small box packaging. The intelligence of the complete set of equipment. It can be said that the intelligent packaging of food and medicine boxes is the trend of modernization, scale and GMP development, which will contribute to cost reduction, efficiency and intelligent management of food and pharmaceutical production.
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