1 Development of clean room performance of medical packaging plastic product molding equipment
According to the GMP standard, do a good job in the design, manufacture, and quality management of cleanroom standards for medical packaging plastic product molding equipment.
Medical packaging plastic products are not contaminated by airborne particles (dust, bacteria, viruses) during the forming process and the entire forming process is in a clean environment. Therefore, the standard of clean room is the basic quality standard for forming high-end medical plastic products, and it is also different. The most important difference between other plastic molding equipment. The standard design of clean rooms for medical plastics molding equipment is often insufficient. The cleanliness standards for medical packaging plastics molding equipment are equivalent to ordinary plastic molding equipment. The safety and quality standards for molding plastic injection molding products cannot be guaranteed.
The layout of the cleanroom standard for domestic medical packaging plastic product molding equipment is placed in a clean room as a whole, expanding the space of the clean room, and also raising higher requirements for equipment design and manufacturing.
1.1 Net room standard molding equipment
In order to meet the requirements of the clean room standard, the equipment drive form should be fully electric to reduce the pollution of the oil to the environment. However, an all-electric drive must also have a deficiency, that is, electrostatic induction generates pollution, so anti-static induction settings should be used. Prevents equipment from causing secondary pollution to the environment, such as the use of non-oil-lubrication guided motion equipment, anti-static induction facilities, anti-oxidation and anti-rust treatment of metal parts, surface treatment of cast parts except sand and oxide scales, and no paint on equipment surface, relative motion The exposed parts are chrome plated to achieve long life rust protection, special parts are separated by stainless steel plate, the whole machine adopts fully enclosed dustproof structure, sliding guide rails are equipped with special protective cover, the whole machine adopts fully enclosed dustproof structure, etc., to reach the maximum Limits reduce the attachment of contaminants, improve cleanliness, and reduce the difficulty of cleaning. Hydraulically driven oils apply FDA-compliant, non-toxic hydraulic fluids. The hydraulic drive is changed to servo motor drive, which is more conducive to achieving clean room standards and improving performance and production efficiency.
1.2 Cleanroom Standard Peripheral Equipment
Cleanroom standard peripheral equipment and configuration. Equipment manufacturing companies must provide a complete set of clean room solutions from raw material storage, drying, product formation and storage. Manipulators, feeding equipment, mold temperature, cooling equipment, product delivery equipment, etc., selection, configuration should comply with GMP and other related standards. Avoid or reduce the secondary pollution of the clean room, the surface requires low adsorption capacity, clean, easy to clean and disinfect.
1.3 Clean room standard mold/head
The clean room standard mold/handpiece must have properties that do not produce regenerative contamination of the product and work environment. The surface of the overall surface and related parts needs special coating process to isolate the mold from possible contamination of the product. The mold liquid cooling / blowing interface is fully sealed to prevent leakage of product contamination. The personnel who completely achieve product removal and stacking are “without contact†to prevent contact with the contamination.
Special handling of the mold/handler flow path. The molten raw material is injected into the mold cavity, held under pressure, cooled and qualitatively removed from the forming zone, undergoing processes from the molten state to the solid state, from high temperature to low temperature, and high shear, in order to avoid deterioration and contamination, the mold The flow channel design should be reasonable and the surface of the flow channel should be specially treated. The hot runner system can effectively control the filling temperature of the molten material, reduce the flow resistance, and effectively control the possibility of decomposition of the molten material due to overheating. It is particularly effective for products that are easily overheated and decomposed during processing such as PC and PET. Performance protection features.
1.4 Self-cleaning feeding system
To ensure that the plasticized plastic raw material is not polluted by the outside is the first step to ensure the purity of the medical plastic product, and the feeding system that ensures the cleanliness of the plastic raw material becomes a subject of research and development. TSM Auto-Clean's exclusive design automatically controls and monitors the cleaning process for self-cleaning feeding systems, including a complete cleaning system for the suction feeder to the mixing tank, a metering blender for automatic cleaning procedures, between recipe conversions, Does not cause cross-contamination between materials; the five-stage control procedure uses automatic gas valves to remove the remaining plastic particles from the entire mixing line; specially designed automatic diverted feed line valves can still supply the main raw material into the machine during the cleaning process. Plasticization of the tube.
1.5 Self-cleaning barrel heating system
The barrel plus heat plasticization device is a system common to the packaging plastic product molding equipment. The electromagnetic induction heating system itself operates at a low temperature and does not burn foreign matter adsorbed on its surface: such as plastic particles, oil, dust, etc., will not produce harmful gases and will not cause pollution to the surrounding environment.
2 Development of Injection Molding Equipment for Medical Packaging Injection Products
Injection molding equipment refers to the plastic material plastic injection molding is carried out by the injection mechanism, molten plastic into the mold cavity into the product under high pressure injection molding, molding mechanism according to the needs of molding products with a variety of types, the molding mold is also different The structure and pattern. Medical packaging injection molding equipment is mainly used for forming bottle containers, cavity containers, bottle caps, and preforms with equal diameters in the cavity and bottle mouth.
2.1 Medical Packaging Plastics Injection Molding Equipment Performance Development
Medical packaging plastic injection molding equipment is different from general injection molding equipment and has its own characteristics, especially the design, manufacture, assembly, etc. of the cleanliness of the whole machine.
2.1.1 Clean Performance Development
The power drive adopts the form of water cooling. The water-cooled converter and the water-cooled motor ensure effective heat dissipation, eliminate harmful gases due to local high temperatures, and stabilize the temperature of the hydraulic oil and improve the running accuracy. The fully enclosed design meets the GMP certification standards, and the cleaning door is set to facilitate the disinfection and cleaning of the whole machine. Independent product molding area and injection molding area. The metal surface of the product forming area and the blanking device is protected against oxidation. Closed injection molding area has waste water and gas outlets.
The high-quality hot runner cluster cavity medical product mold ensures that the molten material does not change in performance when entering the mold, and eliminates the possibility of contamination caused by the qualitative change of the molten material in the molding process.
2.1.2 High efficiency and high yield
High-powered and high-tech motion systems achieve short cycle times and high-precision production, increase production efficiency, reduce energy consumption, and reduce production costs. Optimize the molding process, shorten the cycle time, and increase productivity.
2.2 Development of cleanliness and mold clamping mechanism
The concave and convex molds of the mold are respectively mounted on the fixed mold and the movable mold of the mold clamping mechanism to complete the molding of the product. The cleanliness of the space between the fixed template and the moving template is directly related to the cleanliness of the product. The structural design of the cleanliness becomes the focus of the mold clamping mechanism of the medical plastic injection molding machine.
2.2.1 Clean lubrication system
Ordinary horizontal injection molding machine clamping mechanism has four rods, elastic deformation of the clamping force, and at the same time used as a template guide, the lubricant on the rod is not only easy to stick to the dust pollution in the environment, but also in relatively high-speed operation It is easy to produce pyrolysis and harmful toxic gases directly pollute the products.
Closed cycle oil system prevents contamination of the product due to oil leakage. The non-lubricated tie rod guide sets completely eliminates the contamination caused by the use of tie rods of the common mold clamping mechanism as a guide and lubrication. Box-type structural design thimble drives reduce the risk of contaminated products.
2.2.2 Clean Rodless Clamping Mechanism
No tie bar clamping mechanism, clamping force generated by the elastic deformation of the “C†type frame, no tie bar, fundamentally eliminates the contamination caused by the tie rod guide lubrication pair of the tie bar clamping mechanism, and is easy to design into a fully closed product. Molding environment improves the cleanliness of the molding environment. Moreover, because of its simple structure, large space for molds, easy installation and disassembly of molds, it is beneficial to the operation of robots. Engel first developed a tie-barless mold-clamping mechanism for the injection molding of medical plastic products, occupying a larger share of the market for medical plastic injection molding equipment.
Domestic equipment developers have not fully understood the unique properties of the pull-free clamping mechanism and have not received enough attention. Jilin Huawang Plastic Machinery Co., Ltd. Yuki was the first domestic injection molding machine with a clamping force of 500 kN in the country. In the past, it has not been manufactured and researched by other manufacturers.
2.2.3 Cleaned Direct Pressure Closing Mechanism
The guide of the moving template of the common direct-pressure mold-clamping mechanism is similar to the hinge-clamping mechanism of the elbow, and there is also the problem of oil pollution. The direct-pressure mold clamping mechanism increases the smoothness of the operation of the moving platen because the mold clamping cylinder directly acts on the center area of ​​the moving platen. The development of non-oil lubricated ball linear guides provides a new mechanism for guiding the moving formwork. It is used as a guide mechanism for moving the formwork in the direct-pressure mold-clamping mechanism. The lubrication couple between the tie rod and the moving platen is eliminated, completely eliminating lubrication. Oil pollution.
2.2.4 Clean "C" Type Vertical Clamping Mechanism
"C" vertical mold clamping mechanism, clamping force generated by the elastic deformation of the "C" frame, there is no tie rod, so there is no guide lubrication pair of the tie rod and the template, and it has the same cleanliness as the tie rodless mold clamping mechanism. performance.
2.3 High-speed PET, PP medical preforms oil-electric composite drive plastic injection system
The speed and cycle of plastic injection molding are directly related to the product molding cycle. Innovative plastic injection molding mechanism to improve the quality of plasticization and production rate. The performance of the injection plasticizing mechanism is directly related to the quality of the preform. Ordinary reciprocating screw plastic injection, due to inconsistent quality of the front and rear plasticizing, resulting in inconsistent preform quality; and because injection and plasticization can not be carried out at the same time, reducing the production efficiency. The extrusion injection compounding plastic injection system [1] divides the plasticization and injection functions into two parts from a conventional one, namely, the servo motor drives the extrusion screw independent plasticization and the hydraulic plunger independent injection, If the two do not interfere with each other, the axial temperature of the PET and PP melts can be stabilized to achieve consistency in the quality of plasticization, and at the same time, the productivity is greatly improved. Canada Husky Corporation [2] injection PET PET bottle preform injection molding machine for PET preforms, extrusion injection composite plastic injection system, AC servo motor direct drive extrusion screw plasticization system combined with the company's international leading hot runner mold, Forming a model of 96 preforms, the cycle time is less than 7.5 seconds, that is, the output per hour reached 46,000; PET300 preform injection molding machine, forming a mold 72 preforms, the cycle is less than 5.5 seconds, that is, the output per hour reached 47,100 . It is worth mentioning that the screw injection action, the injection machine in the molten material injection action is the injection of the screw is not a simple straight forward movement but in the same direction of rotation with the rotation of the very low speed of the forward movement, reducing the injection piston The shearing force with the inner wall of the injection cylinder reduces the probability of decomposition of acetaldehyde and eliminates the backflow of molten material that may be generated by injection. The use of large-diameter screw plasticizing shortens the plasticizing stroke, the plasticizing stroke is about 1D, shortens the molding cycle, improves the temperature uniformity of the plasticized melt material, and is beneficial to the consistency of the quality of the group cavity preform, and at the same time, the production is improved. effectiveness. Ke Li PET630-96 high-speed preform injection molding machine, plastic injection system using a synchronous plastic double extrusion composite system, plasticization and injection at the same time, shorten the production cycle and increase productivity.
3 Medical molding equipment for hollow packaging plastic containers
Medical hollow packaging plastic containers are mainly composed of blow molding hollow molding equipment, injection blow blow molding equipment, blow blow molding equipment, multi-layer co-extrusion blow molding equipment, and blow blow molding equipment. Injection blow/injection blow molding blow molding machine is mainly used for processing thin-walled container medical products with small and medium sized cavities. Extrusion blow molding machine is mainly used to process thick-walled and small-volume solid drug medicine bottles with cavity larger than caliber. Pull-blow molding equipment is mainly used for large-volume medical products such as thin-wall infusion bottles and cleaning clothes bottles whose main processing chamber is larger than the bore diameter. The multi-layer co-extruded hollow equipment mainly processes container-type medical products that have special chemical properties and physical properties required for containing liquid agents.
3.1 Injection Blow Molding Equipment for Medical Hollow Packaging Plastic Containers
The State Drug Administration as early as during the "Ninth Five-Year Plan" put forward the use of injection blow molding equipment to produce high-quality plastic bottles. The injection blow molding equipment refers to the injection of molten material after the injection of molten material through parison molding - blow molding. The process is the final product and is mainly used to process medical bottles of HDPE and PP raw materials. Injection blow molding can not form a complex shape of the product, and the majority of the molded bottle volume (usually 10 ~ 300ml). The injection molding of the blow-molded bottle has a high flatness and a uniform wall thickness. In particular, the bottle mouth and the bottle cap have good sealing performance, which can prevent the volatilization of the drug gas in the plastic bottle and the penetration of external gas into the bottle. The performance requirements thus make this bottle fully comply with the special requirements of pharmaceutical packaging. At present, China has imported more than 40 injection molding blow molding equipment lines from abroad, with a total production capacity of approximately 700 million per year.
Injection blow molding equipment is divided into three stations and two stations. The three stations of the three-position injection blow molding machine are distributed in an equilateral triangle with an angle of 120°. The first station is the injection molding station, the second station is the blow molding station, and the third station is the Bottle and cooling station. The three stations can be operated at the same time. The production efficiency is high and the cycle is short. It can be automatically counted and packaged with the conveyor belt to truly realize the “no contact†with the manpower in the whole production process of the medicinal plastic bottle, thereby ensuring the product is hygienic and clean. Two-station injection blow molding equipment lacks a dedicated removal and cooling station, making it difficult to achieve automatic counting and packaging.
Injection blow molding equipment is a rapid development of medical bottle molding equipment in China, occupying a large proportion in the domestic market, technological progress is also faster.
3.2 Medical hollow plastic container "Note-pull-blowing" molding equipment
Injection Blow Molding Blow Molding Equipment refers to the injection of molten material after the molten material is passed through the parison molding-stretching-blow molding process into the final product. It is mainly used for the processing of liquid medicine filling containers for PET and PP raw materials. Injection molding parisons, heated parisons, stretch parisons and blow molding, and demolding of molded products can be performed continuously on the same equipment with high efficiency. According to the molding process, the one-step model is divided into two types of machines: three stations (represented by Japan's Aoki Plant) and four stations (represented by Japan's Nissei Machine). The main difference between the two is that “three stations†refers to the injection of parisons and heated parisons in one process, and “four stations†refers to the injection of parisons and heated parisons in two processes. The one-step model will not cause secondary pollution of the product, and the product identity is good. In spite of the high prices, in order to achieve the high cleanliness requirements of pharmaceutical bottles, domestic pharmaceutical manufacturers have tended to use one-step “injection-pull-blow†vial molding equipment in recent years. Some domestic equipment manufacturers have stepped up the development of one-step models that can replace foreign equipment on the basis of digesting and absorbing foreign advanced technologies, and have achieved certain results.
One-step method "injection-pull-blowing" The research and development of the vial molding equipment mainly focuses on the development of molds for injecting parisons. The focus of the mold development is on the material of the mold, the design of the hot runner nozzle and the hot runner, and the temperature control system.
3.3 Extrusion Blow Molding Equipment for Medical Hollow Packaging Plastic Containers
Extrusion blow molding equipment (including blow molds) has a low manufacturing cost and flexible replacement products. It can be used to form large hollow hollow containers that cannot be molded. Extrusion blow molding can be used to form hard medical hollow plastic containers of HDPE and PP raw materials with complex, irregular, and uniform shapes. The product's production costs are also lower. Parisons are formed at lower pressure through the extrusion head and are blown under low pressure (mostly 0.2-1.0 MPa), so the residual stress of the product is small, and it is resistant to stretching, impact, bending and environment, etc. The strain has higher performance and better performance. Since the blow mold is composed of only the female mold, the wall thickness of the bottle can be changed by simply adjusting the gap of the die mouth or the extrusion conditions. As the sliding bottom module can be set on the blow mold, the design flexibility of the bottom shape of the bottle body is greater.
The technical requirements for extrusion blow molding machinery are not high, the requirements for production efficiency are not high, and the quality requirements for molded medical bottles are not high. Therefore, domestic equipment is mainly used in this field.
Increasing the speed of molding and reducing the weight of products is the development direction of extrusion blow molding machinery.
3.4 Medical Hollow Plastic Containers Compression Blow Molding Equipment
The Italian Sacmi Machinery Group has innovated the development of compact blow-molding equipment for small, wide-necked, hollow containers that are particularly suitable for forming medical applications. This production technology combines the compression process developed for the production of plastic caps with the traditional blow molding process in a single integrated sequence. The compression mold is mounted on a carousel and is equipped with a polymer melt dosing plug for preforming and can be configured for blow molding or stretch blow molding. One size is a 16-cavity molding apparatus that can produce a container with a maximum diameter of 77 mm; the other size is a 20-cavity molding apparatus that can produce a container with a maximum diameter of 56 mm. The equipment can also be integrated with the Combo filling line, eliminating the need for sorting and further processing of containers. This technology reduces the weight of the container, reduces the generation of waste, and improves product quality. The energy consumption is 30-40% less than injection stretch blow molding equipment.
3.5 Medical OPP infusion bottle blow-molding equipment
OPP transparent bottle in the large infusion bottle is a new product developed in recent years. From injection molding of preforms to heat-flow molding of preforms to blow-molding equipment, the entire production line was formed. Hundreds of sets of stretch blow-molding equipment were successfully applied to domestic and foreign customers, among which the production lines abroad were distributed in more than 10 countries including Germany and Japan. And area. Independent innovation launched a high-speed linear stretch blow molding machine for PET bottles with a single mold productivity of 1500/hr. The Model CLP-1200SP has 12 mold cavities with an hourly capacity of 18,000. The Model CLP-1500SP has 14 mold cavities with an hourly capacity of 21,000. The main technical features of CLP series PET bottle high-speed linear stretch-blow moulder: The take-off billet and its transmission adopts the most advanced servo drive cylinder system with the most advanced high-dynamic reflection performance; the preform is smoothly and accurately controlled by means of a special rotary dial type conveying mechanism. Transfer to heating fixture. Fixtures of different specifications can be used for quick unloading of preforms of different specifications; special voltage modules, self-feedback function automatically identify changes in the voltage of the power grid to adjust the heating power output, to ensure that preform heating is not affected by the external power grid, to achieve stable heating; through independent innovation The cam mechanism controls the up and down movement of the bottom mold of the blow mold at a high speed to shorten the blowing cycle; the high-speed and sensitive integrated blowing valve improves the blowing speed; and the dual-function cooling system of the cold/cold water protects the stability of the preform mouth size.
Improve the blow molding rate and yield. Developed a high-speed and stable conveying mechanism, a bottle blowing system, a heating system, and a bottle taking system. Hydraulic drive instead of servo drive to enhance the cleanliness. Rotary blow molding machine gear transmission mechanism, a large number of lubrication pairs, to the cleanliness of the product to bring hidden problems, innovation and improvement should be.
3.6 Environmental blowing equipment for medical hollow plastic containers
Liquid medicine filling bottles are generally blow-molded. The new air recovery system developed by SMI can effectively reduce the consumption of compressed air by 40%. Save energy costs. The air recovery system allows high-pressure gas in part of the blowing circuit to be reused for pre-blowing. The working pressure of the pre-blowing circuit can be adjusted by an electronic controller, and the servo loop is controlled by a manual pressure reducing valve. The bottle blowing equipment developed in China has no air recovery system and wastes energy. It needs to absorb advanced technology, innovate and develop, achieve environmental protection blowing, and improve cleanliness.
3.7 Resource-saving medical hollow packaging plastic container molding equipment
To realize the lightweight and thin-walled plastic hollow packaging plastic containers, save plastic raw materials, and reduce social energy consumption. Thin-walled, lightweight medical hollow packaging plastic containers, from the container design to the tray loading process, from injection molded preforms to stretch blow molding, are all revolutions of the traditional structure of the equipment and molding process, and have opened up the pharmaceutical industry. Another revolution in bottle-forming equipment. Medical hollow packaging plastic containers have great potential for saving energy and reducing consumption, and the benefits are considerable. 500 ml PET hollow bottle, domestic bottle weight is generally the lightest 16 grams, the international generally is 12 grams, the lightest is only 6.6 grams [5], such as 12 grams can be calculated, that is, each bottle is reduced by 4 Ke, a company with an annual output of 3 billion bottles, can save 12,000 tons of raw materials in the whole year, and can calculate 13,000 yuan per ton, which can save 156 million yuan. At the Drinktec exhibition in 2009, the 8.8-gram, 500-ml PET bottle was carrying a mass of 30 kg by improving the bottle design, which was better than the 12-gram, 500-ml PET bottle that was exhibited at the same exhibition four years ago. The carrying mass of 15 kg means that reducing the weight does not mean reducing the performance.
3.8 Connection equipment that seamlessly combines blow-molding equipment and filling line
The seamlessly combined production line of stretch blow molding equipment and bottling line refers to the collection of various processes such as stretch blow molding of preforms, filling, labeling, sealing and packaging of raw materials, and the production of medical packaging. The clean and hygienic aspects have been reliably guaranteed. The filling of raw materials does not require the bottle to be cleaned again, no air conveyor belt is required, and the filling is performed in a closed, non-pollution environment, truly realizing the “unmanned hand contact†of the entire production process, thereby ensuring the cleanliness and hygiene of the product. The preform is effectively dedusted under filtered air, the filling environment is isolated from the external environment, the lid is dusted, and the positive pressure seals the lid. For example, the medical infusion bottle blow molding production line produced by Lomera Company adopts purified compressed air to blow molding infusion bottles, and then immediately injects liquid chemicals and seals, which are then transported by the transport mechanism to the packaging station for packaging. Rommelag's Boffelpack three-in-one device, using PP plastic bottles, is suitable for sterilization at 121°C. It completes the aseptic packaging of a seamless combination of blowing, filling, and sealing liquids on a single device. The risk of air pollution on drugs is simple, reliable, and economical.
Resolving the precise synchronization of stretch blow molding equipment and filling equipment is the only factor that affects the efficiency of the entire system and is the key to the seamless integration of the two.
3.9 Multi-Layer Co-Extrusion Blow Molding Machine for Medical Multilayer Hollow Plastic Containers
The multi-layer composite vial has the property of avoiding light transmission and preventing gas penetration of CO2 and the like, and can meet the requirements of certain bioengineering drugs that require special storage conditions, and has now become one of the main products in the pharmaceutical packaging market. For example, a three-layer co-extruded plastic bottle (the outermost layer is a PA material, the middle layer is a PET material, and the inner layer is a PC material) has good transparency and tightness, and can block moisture and oxygen, and can not only be used as conventional blood. Products, such as direct packaging of human serum albumin and fibrin collagen, can also be used as packaging materials for various bio-engineering drugs such as interferon and various antibody drugs.
The multi-layer co-extruded hollow bottle molding machine has greatly improved complexity compared with other hollow molding machines, especially in the design of the machine head. At present, the R&D of this model mainly focuses on the following three points: (1) The coextrusion head with a certain range of use is studied to meet the requirements for different materials, different layers, and head diameter. The head is the “heart†of a multi-layer co-extruded hollow plastic molding machine. Its performance should be: to control each layer to achieve the best state to achieve a complete distribution of the circumferential and lateral materials; the processing variation can be affected without the influence of material distribution. Extensive plastic raw materials. The spiral mandrel combination system is highly adaptable and should be the preferred system for multi-layer co-extrusion heads. (2) Study the combined packaging system so that the heads of possible combinations can be tailored to different raw materials. (3) Study basic mechanical procedures to determine the number of molding stations, production speed, and platform dimensions for product design.
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