First, the introduction
The "note-blow" molding process originated in the early 1950s. The application of foreign polyolefin (HDPE, PP) medicinal plastic bottles was earlier than the seventies. Related equipment research and manufacturing manufacturers include Wheaton, Jomar, Battenfeld, Bekum, Japan, ASB, Aoki, and Uniloy Milacron of Italy. The main models are one-step three-station, the United States and Japan adopt vertical screw structure, Germany, Italy uses a horizontal screw structure.
The first batch of domestic systems to introduce “note-blowing†production lines and produce pharmaceutical packaging plastic containers are Tianjin Lisheng Pharmaceutical Factory (1984) and Shanghai Daming Glass Factory (1985), and comprehensively promote polyolefin drugs for digestion and absorption in China. A lot of basic work has been done with plastic bottles.
Since 1989, Jiangsu Weida Machinery Co., Ltd. has developed the first “three-station†one-step “note-blow†molding machine. It was first put into the market in 1991. After more than ten years of hard work, it has made great progress. With the development of China's pharmaceutical industry and the support of the majority of users, in recent years, with the rapid development of 100 production lines per year, the overall quality level of Chinese pharmaceutical packaging containers (especially solid pharmaceutical tablets and capsule packaging) has been greatly improved. Upgrade.
Second, the common production process and raw material selection of medicinal plastic bottles
1. Production Process
(1) "Extrusion-Blow moulding"
Also known as hollow extrusion blow molding. The extruder continuously extrudes the hollow tube, cuts it into small pieces with scissors (manual) or a cutting device (automatically), and then moves it into an extrusion blow mold to blow mold.
Advantages: simple equipment, low investment, low cost.
Disadvantages: the bottle mouth is not flat, the seal is very poor. The raw material is usually LDPE, the barrier property is much lower than HDPE/PP, and the shelf life of the charge is short.
(2) Two-step method "Note-Blow" Two steps injection-Blow moulding.
"Injection, blow molding" is carried out separately by two separate machines, commonly known as the "two-step method." The first step: injection molding of the tube blank by a common injection molding machine, the bottle head portion (bottle opening, thread) of the tube blank has been formed; the second step: manually placing the tube blank on a honeycomb heater or an automatic circulation heating conveyor belt Heat and adjust the temperature, then move to the blow molding machine and blow it with compressed air.
Advantages: The equipment is simpler and the investment is less. The bottle mouth is flat and well sealed. The variety development is fast, the mold cost is low, and the cost price is medium and low.
Disadvantages: Injection tube blank and blow molding are carried out step by step, easy to transfer pollution, difficult to ensure bacterial inspection, poor product identity, not suitable for mass production.
(3) One step injection-Blow moulding.
"Injection, blow molding" is done on the same machine. According to different models, it is divided into three stations and two stations "Note-Blow". The three stations of the three-station "blow-blow" bottle making machine are distributed in equilateral triangles at an angle of 120°. The first station is an injection molding station, the second station is a blow molding station, and the third station. For the decoupling station.
The three stations can be operated at the same time, with high production efficiency, short cycle, and can be automatically counted and packaged with the conveyor belt. It can truly achieve “no contact†with the human hand during the whole process of medicinal plastic bottle production to ensure the product is clean and hygienic. The second station "Note-Blow" plastic machine can be arranged in the upper, lower or front and rear positions; the first station is the injection molding station, the second station is the blow molding station; because there is one special de-bottle and cooling Stations, so it is more difficult to achieve fully automatic counting packaging (generally for bulk manual counting). In addition, the production cycle is longer and the production efficiency is lower than the three stations.
Advantages: high degree of automation and high production capacity. The bottle mouth is flat and the seal is excellent. HDPE/PP raw material is selected, the bottle wall is uniform, the barrier property is excellent, and the storage and shelf life is long. At present, domestic standardized drug package enterprises basically adopt one-step "injection" process equipment, of which the "three-station" structure is the main.
Disadvantages: equipment investment is large, the mold is complex, and the system configuration requirements are high. Not suitable for small varieties, small batch production. However, high-volume production can achieve high quality and low cost with good economic returns.
2. Common plastic materials
Solid pharmaceutical packaging should use HDPE/PP, one-step "blow-blow" process to produce polyolefin plastic containers; liquid medicine filling should use PET/PP "injection-pull-blowing" process to produce plastic containers.
Colorants and processing aids
The coloring agent of the vial is usually selected from titanium dioxide TiO2 (anatase or rutile), wherein the TiO2 content is ≥98% Wt, and the addition amount is 1.0-1.5% Wt.
Common processing aids are lubricants such as zinc stearate and polyethylene wax. Both are white powders, and the addition amount is 0.1-1% Wt.
In recent years, in order to meet GMP and 100,000 purification requirements, TiO2, zinc stearate, polyethylene wax and LDPE (high M•I) are generally mixed together to form a concentrated masterbatch, which can greatly reduce dust pollution during production. .
The typical TiO2 color masterbatch consists of the following:
TiO2 (special grade) 60%
Zinc stearate 8%
Polyethylene wax 10%
LDPE 22%
For solid pharmaceutical packaging, HDPE and PP are suitable materials with excellent resistance to water vapor permeation, which can effectively prevent the moisture absorption and deterioration of drugs. However, drugs that are susceptible to oxidative deterioration should be used with caution. LDPE has very poor oxygen barrier properties, it is not suitable for the production of medicinal plastic bottles, and it is not possible to fill drugs with long shelf life. PET has excellent barrier properties against water and oxygen, and its appearance is transparent. It is an ideal choice for filling liquid drugs (syrup, oral liquid).
Third, medicinal plastic containers "note - blowing" molding equipment and mold
The structure includes: injection mold (initial mold), blow mold (forming mold), mold core rod (three groups), hot runner, sub-nozzle, de-cucking card, and core rod assembly.
Mold materials, thermal expansion coefficient, surface finish, processing technology and precision, design level, debugging experience, especially the control of injection mold temperature have an impact on the quality of the final pill product.
Vida Huafeng Precision Mould Co., Ltd. is a professional manufacturer of Vinda Machinery supporting the design and production of “Note-Blow†molds. It produces 300sets/y of various specifications and precision molds. It has 3D modeling CAD and CAM technology. Two sets of Cincinnati machining centers, imported high-precision electric pulse 6 sets from Switzerland and Taiwan, guarantee the precision and quality of mold processing.
Fourth, system design
The influence of the system design and supporting equipment on the efficiency of the “injection-blowing†line should be taken seriously.
In addition to selecting reliable “injection-blowing†molding machines and precision “injection-blowing†molds, medicinal plastic bottle manufacturers must carry out system design planning for the corresponding GMP specifications and processes. The main contents include:
1. Central air conditioning system (GMP standard factory building, 100,000 class purification, GB/T 16292-16294-1996)
Main indicators: 100,000 cleanliness, three-stage filtration (fine, medium and high), and top-to-side mode.
Air exchange times ≥ 20 times / hr 〓 temperature T = 26-28 ° C
2. Chilled water system
Temperature T=5°-15°, pressure P≥0.2Mpa, flow rate Q≥rated value
3. Cooling water system
Temperature T≤28°, pressure P≥0.2Mpa, flow rate Q≥rated value
Spraying, circulation system
4. Compressed air system
Pressure p≥1.0Mpa, flow rate Q≥calibration value, configuration regulator tank, freeze dryer, secondary filtration (40μ, 5μ), automatic drain valve, compressed air temperature 65°<20°C.
5. Mold temperature controller
Water medium mold temperature machine: working temperature Tmax ≥ 120 ° C, P ≥ 0.4Mpa, microprocessor or PID control.
Oil medium mold temperature machine: working temperature Tmax=30-300°C, P≥0.2Mpa, PID or primary position control instrument.
Suggestion: The production of medicinal plastic bottles uses water medium mold temperature machine to ensure the quality of the medicine bottles and prevent leakage of oil medium.
6. Mixing, feeding and pulverizing device
The mixing time is controllable (timer), and the optimal mixing effect can not be achieved if the length is too long or too short.
The feeding method is recommended to use top layer feeding or automatic vacuum feeding method, but the coloring of the concentrated masterbatch should be used to prevent the dust pollution in the workshop from exceeding the standard.
The pulverizer should use a low-noise, high-efficiency rotary cutter (mainly crushing the bottle cap injection flow channel rack and a small amount of waste bottles), and the amount of returning material should be reasonable and appropriate (less than 15% wt) to prevent repeated cycle degradation. performance. The raw materials of different grades must be treated separately (general bottle resin M•I≤1.0, cover resin M•I>5), and can not be mixed at will.
V. Discussion
Pharmaceutical plastic bottles produced according to their specific properties should:
1. Select the “Note-Blow†process to ensure the smoothness, high density and excellent sealing and penetrating performance of the bottle mouth, thus ensuring the stability of the charge and prolonging the storage shelf life.
2. Select one-step three-station "injection-blowing" molding machine and precision mold to ensure product precision, so as to achieve high quality, high yield, high efficiency, low cost and fast return on investment.
3. System design (GMP, process flow, chilled water system, cooling water system, compressed air refrigeration system, electrical system, auxiliary machine) is an important link and a necessary condition for stable production and development of pharmaceutical package enterprises.
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