Plastic Bottle Infusion Workshop Design

The construction of a plastic bottle infusion workshop has not yet begun in the country. The design of such a workshop is a new topic for most domestic pharmaceutical design companies. Here I will talk about the problems that I encountered in the design work and discuss it with everyone.

First, the equipment:

The main equipments included in the plastic bottle infusion production line include the bottle-making machine, the sealing line, the liquid supply tank, the sterilizing cabinet, the leak detection, the light inspection, the labeling packaging line and so on.

1. Bottle making equipment:

(1) Introduction to bottle making principle and production method:

The biggest difference between the plastic bottle infusion production line and the glass bottle infusion production line is the increase of the plastic bottle making machine equipment.

Plastic bottles are generally manufactured by the infusion factory itself, reducing pollution and manufacturing costs. The material is made of polypropylene or polyethylene. The manufacturing process is generally followed by raw material mixing, melting, injection or extrusion, blow-molding, post-treatment, cooling, inspection, and trimming of scraps. Reuse other steps. Plastic bottle forming methods can be divided into biaxial stretch blow molding, hollow molding, injection stretch blow molding three methods.

Blow molding is the main method of forming hollow containers. Mainly through the extrusion or injection of thermoplastic material into a tubular parison (preparation), then the mold is used to clamp the ring and pass through the compressed air nozzle inside the mold to blow compressed air into the parison to form a hollow body and cool Curing. The process has hollow blow molding or hot parison molding; injection blow molding; cold parison blow molding and so on. In injection molding, the injection molding machine quantitatively injects the molten resin into the film chamber and takes it out after cooling. Injection stretch blow molding (referred to as a one-step method) is relatively advanced, the transparency of the bottles is better, the yield is also larger, and no scrap is produced. However, the current domestic prototype operation is not ideal. As for the bottle-making, filling and sealing (without cover) "three-in-one" infusion bottle equipment, the floor space is small and the efficiency is high, but there are also certain defects, mainly poor transparency and unevenness. The one-step method and the "three-in-one" method currently only rely on imports.

The main principle difference between biaxial stretch blow molding (two-step method for short) and blow molding method (for extrusion blow molding) is that the two-step method uses an injection molding machine to make preforms, and the hot parison is blow-molded in a cold parison; The method is to first make the pipe, and then press the hot parison to shape. The equipments of Guangdong Krupp and other companies can complete the processes of pipe making, press forming, and cutting scraps in one machine, but the transparency of the bottles is relatively poor. The two-step equipment must first make the preform on the injection molding machine. Before the parison is heated for the second time, it needs to cool the parison. The length of the cooling time directly affects the transparency of the molded plastic bottle. Larger area.

(2) Equipment selection and layout:

What kind of bottle making equipment is selected, how to lay out is the core problem in designing plastic bottle infusion workshops. At present, there are several kinds of bottle-making machines in the country: one-step injection-pull-blow molding machine, imported bottle-making, filling, and sealing (without cover) three-in-one plastic bottle infusion production equipment. Blow molding machine, two-step preform biaxial stretching machine. From the perspective of advanced nature, of course, it is better to use one-step injection stretch blow molding equipment, but import equipment prices, arrival time, inspections, technical services, and many other aspects are very unsatisfactory, and large-scale development is greatly limited. In recent years, extrusion lines and two-step methods have been used in new bottle lines in China. Extrusion and blowing equipments have a small footprint and high production efficiency, but the transparency of bottles is worse than that of two-step devices.

The one-step method and extrusion blow method equipment layout is relatively simple, mainly based on the characteristics of the selected equipment, combined with the specification of the plane design. The layout of the two-step equipment design is relatively difficult, not only how to effectively use the floor space of the equipment, but also to consider the effective connection between the two-step process and the filling machine, as well as the processing method of the preform storage section. (In view of the technical confidentiality of each pharmaceutical company, it is inconvenient to provide explanatory drawings.) I personally believe that the connection between making embryos, bottles, filling and sealing is the best choice for design, and it is also a key issue for equipment manufacturers. Doing so can make the production layout smooth, convenient logistics management, increase the area utilization, reduce the chance of bottleneck contamination.

Another difficulty in designing the layout is that as the production scale of plastic bottle infusion continues to expand, a production line can no longer meet the requirements. How to soften several production lines with the same process or different processes into a single workshop requires the design of each specialty of the institute, Manufacturers, equipment manufacturers, several parties work together to find ways.

2. Filling and sealing equipment:

Bottle filling and sealing equipment mainly includes import and modification. From the perspective of the use of various companies, imported equipment is not very ideal, so manufacturers have to choose the "triple play" production line. At present, the relatively good domestic use is the potting equipment of Hengyang Qianshan. The working principle is as follows: the plastic bottle is pushed into the positioning clip by the bottle inlet mechanism, the positioning clip is fixed on the chain, the chain is used for intermittent movement, the plastic bottle is driven by the chain, vacuum bottle vacuum leak detection, ion air blowing and washing, and filling are performed in sequence. Nitrogen, filling, capping, heating, cap sealing, and bottle ejection.

In addition, there are also manufacturers to use plus butyl rubber plug, aluminum platinum sealing capping technology. Filling equipment using this technology can be retrofitted from old glass infusion filling line equipment, or can be retrofitted with new capping equipment after the new plastic bottle filling equipment. Because the equipment cost of this method is much lower, Shanghai and Hunan are all equipped with equipment factories, and even some infusion plants are also refitting themselves.

Regardless of what kind of potting technology is used, the design must start from the three key links of washing, filling and sealing, grasp the technical essentials, allocate the production capacity among various equipment, choose the appropriate configuration method, and ensure that the product quality is the basic requirement for the enterprise.

There is also an important technical problem in potting, which is to use what kind of cap, and how to deal with how to seal the cap. In general, the use of inner and outer cover, and plug combination welding cap sealing technology product grade is slightly higher, but if the welding cap technology if not handled properly, the product cover will be very ugly. The use of butyl rubber plugs and aluminum-platinum-seal capping techniques, although relatively primitive, are practical. Some infusion plants prefer this approach when the cap technology is not fully understood or the welding cap equipment is too expensive.

3, thick and thin tank system and sterilization equipment:

Rich and canned tanks, liquid transfer pumps, filtration devices and large infusion water bath sterilizers are the most common equipment for large infusion workshops. Applied to the plastic bottle infusion production, the difference is: the plastic bottle filling temperature can not be too high, dilute cans to pass the cooling water to cool, with a good liquid medicine to be filled as soon as possible; at the same time the filling equipment production capacity is not great If you choose to alternate filling methods, the volume of thick and thin tanks should not be too large.

The technical requirement of the water bath sterilizer is how to solve the problem that the sterilization temperature of the plastic bottle infusion cannot be too high, and modify the cabinet volume, the frame and the tray according to the volume shape of the plastic bottle. In recent years, there have been two or three sterilizer manufacturers in China that have done very well in plastic bottle infusion sterilization. In addition, the plastic bottle is not like the glass bottle is easy to break, and some filling machines can also find that the bad bottle is not filled, so filling the bottle to sterilize, then to the light inspection, packaging the bottle, the use of rail transport is feasible .

4, leak detection, light inspection, labeling and packaging line:

Leak detection is a common problem in soft packaging infusion production, even if the most advanced foreign leak detection equipment also has some defects or some unreasonable place.

The transparency of the plastic bottle is poor, especially the transparency after sterilization is definite, the difficulty of the lamp inspection is slow, the length of the lamp inspection room and the position of the bottle are also considered during design.

Adhesive labeling machine, ring or hooking machine, plastic packaging box machine can be purchased at home, ring or hook machine can also be customized processing, as long as the equipment line is not a good problem.

Second, the artificial environment of production workshop:

1, the determination of the cleanliness level:

The production level of large-volume injections for irrigation, sealing, and dilution is 10,000, and the encapsulation plus local 100-level laminar flow is stipulated by GMP. With the improvement of product quality, the use of high-quality pharmaceutical raw materials and the application of sealed dispensing systems, many plants have reduced the carbon-adjusting process and have also set the concentration process to 10,000. This is obviously welcome because of the small size of the concentrated process.

The difficulty in the design of cleanliness level is the choice of environment in the bottle making process. Article 16(4) of the “Measures for the Administration of Materials and Containers for Pharmaceutical Packaging (Interim)” of the State Drug Administration stipulates that the production of Class I pharmaceutical packaging products must have the same cleanliness conditions as the production of the packaged pharmaceuticals. The products were inspected by the State Drug Administration or the testing agency designated by the drug regulatory department of the province, autonomous region or municipality directly under the Central Government. (Type I pharmaceutical packaging material refers to the materials and containers for pharmaceutical packaging that are directly in contact with the drug and used directly.) From the above understanding, bottle production and filling production should be at the same level, that is, 10,000. The "Guidelines for the Quality Control of Pharmaceutical Manufacturing" implementation guideline refers to the final processing environment of the large infusion packaging materials is 10,000, that is, as long as the 10,000 grade cleaning treatment qualified, the bottle can be set in the 100,000 class area.

The bottle-making process in the 10,000-class zone is nothing more than raising the level, increasing energy consumption, expanding the area of ​​the 10,000-class zone, and increasing the difficulty of management. But from the perspective of the layout of the entire production plant, it is very favorable. If the design of a single production line, I suggest that you can use the same level; if it is the design of a number of production lines, it must be considered.

2. Purification air conditioning design and air conditioning operation management:

The design of the production process plan must closely cooperate with the design of the clean air conditioning program. What kind of process plan, process layout or process equipment is selected, and the design of the air conditioning must be combined from the outset. For example, according to the difference in production capacity between equipment, the production shifts need to be adjusted, and the air conditioners must be able to adjust the size of the switches and air volume sent back to the air duct according to the requirements. If such requirements are high, it is necessary to design air-conditioning automatic control devices. Otherwise, production will have trouble or increase operating costs. In addition, the bottle-making equipment generally has a large amount of heat, so it is necessary to consider the device self-purification wind device, the air intake from the ceiling, the device comes with net wind facilities, hot air concentrated out of the workshop, reducing heat dissipation to the clean room.

If it is multiple production lines, the air-conditioning design is more complicated. The first thing to consider is whether the bottle-making process is to be set up centrally, but also whether the production lines alternately operate. Therefore, the aspect of air-conditioning operation and management is particularly important.

Third, it is conducive to production management

The workshop design cannot be separated from the production management. Each step of the work must be combined with the actual situation of production management, optimize the layout as much as possible, facilitate the scheduling of production tasks, facilitate the logistics delivery, and straighten out the operation route for personnel.

1, the layout of the production line design:

The main characteristics of large infusion production lines involved in the layout is that the entire equipment production line has a long route (plastic bottle infusion bottle making process, the production line is longer), and try to require an automatic transfer line from end to end, generally avoid disconnection from the middle . In the design, we must use more brains to coordinate this long queue in a certain position, but also not to affect the material transport and facilitate the entry of personnel. Relatively speaking, the design of plastic bottle infusion production line is difficult, especially the combination design of multiple production lines is even more difficult.

2, the production task scheduling:

The infusion manufacturers' production varieties, production specifications, and production output vary greatly, and the requirements for replacement of specifications and adjustments of output must be taken into account in the design. How to match the production capacity between equipments and how to coordinate them. Alternating dosing of concentrated liquid tanks in production is alternately fed. The obstacles to production management are shut down for single equipment in the same production line, and the alternate operation of multiple production lines in the same clean area. . Only by linking the various situations involving production scheduling to the design, can the company be able to use the plant utilization rate effectively and the production efficiency is obvious. Of course, there is no need to put it in a nutshell. Excessive insistence must be placed very smartly in every place. The key is that every step and every process has a proper treatment. Reasonability is the most important.

3, transportation of materials and products:

Plastic bottles infusion workshop materials, product transport, there are two ways: First, intermittent mode, through the transfer window or buffer, flexible packaging manual transport; Second, continuous mode, through the conveyor belt or rail, mechanical transport. The first mode of transportation determines that the design should take into account that the incoming and outgoing lines within the cleanliness area of ​​the production line should be relatively concentrated, and the raw materials, plastic particles, stopper lids, etc. sent into the clean line should be entered as close as possible from one or the other. The route after entering should be as far as possible. Shorten the chances of reducing pollution and deliver faster. The second mode of transport determines the design of conveyor belts or rails when it comes to learning the principles of automatic logistics systems and adjusting the location of equipment to the most suitable place.

4. Arrangements for human access to the human net system:

There are two things to note when designing a plastic bottle infusion plant for workers entering and leaving the production section. One is the problem of the line, because the plastic bottle infusion workshop is characterized by a relatively large number of processes and a bit dispersed, the length of the line into and out of different sections of the staff have a short or long. Although it is not very clear that the flow of people must completely avoid logistics and the flow of people to the non-clean area is not too far away, the rationality of the relationship between the flow of people and the logistics and the convenience of personnel in the non-clean area must still be considered in the design. Reducing personnel's round trips at work and avoiding the cross-contamination of people's logistics is a must for design work.

The second problem is the setting up of dressing rooms in the clean area. Here, we mainly talk about the setting of the net system for multiple plastic bottles infusion production lines. As for the entering dressing procedures, there is not much to mention. From the point of view of production management, the concentration of the human net system is better, but there is a difference between the plastic bottle infusion production processes, and there are relatively independent requirements for the air conditioning systems of different production lines and bottle processes. The centralized setting of the human net system is difficult. . If the net system of people is rigidly set up, mistakes may be made or unsuitable extra structures may be created. Personally, I personally think that different liquids and potting lines will have one set of nets for each person, and the establishment of a bottle of nets for the bottles will be nothing, because it is more convenient to do at least the production schedule afterwards. Of course, if there is a better way to resolve the dispersion of the human net system, it is also worth discussing.

(references):

1. He Zhixiong (Guangdong Nanhai Guangdong Shenzhou Pharmaceutical Co., Ltd.). Progress in soft plastic packaging infusion in China, 2001

2. Gu Weijun (China National Pharmaceutical Foreign Trade Corporation). Current situation and future trends in the introduction of plastic packaging in China, 2001

3. Yuan Mingli (Tianjin Institute of Pharmaceutical Design). How to do a good design for the plastic infusion infusion project, 2001

4. An Maofa (Siping Juneng Pharmaceutical Co., Ltd.). Talking about the status quo and development trend of large infusion soft packaging, 2001

5. Xie Baoyuan (Shanghai Institute of Pharmaceutical Industry). Suggestions for the Development of Infusion Plastic Packaging Containers, 2001

6. Xing Peilong. Plastic Bottled Infusion Production Technology and Development Trend, 2001;04

7. Guo Weitu (former Shanxi Provincial Medical Planning and Design Institute, Quanzhou Southeast Pharmaceutical Biological Engineering Technology Company). Workshop Process Design, 2001