In recent years, China's pharmaceutical flexible packaging has developed rapidly. Among them, aluminum foil used for tablets and capsules has good performance in the protection of blister-packed protective pharmaceutical tablets, has high production speed, has small storage space, is light in weight, and convenient for transportation. The more common it is. It is expected that blisters will account for 60%-70% of pharmaceutical tablet packaging in the coming period. As a manufacturer of aluminum-plastic packaging, every effort has been made to increase production or carry out technological transformations and increase color varieties to meet the market's growing demand for aluminum-plastic packaging. Packaging enterprises in the new equipment at the same time, its production plant and equipment supporting facilities should be consistent with the State Pharmaceutical Supervision Bureau issued by the "direct contact with pharmaceutical packaging materials container production quality management", that is, pharmaceutical packaging materials, "GMP" requirements. This article focuses on how pharmaceutical packaging companies can implement the overall transformation and layout of newly-built extension plants or new equipment as required, and how to purchase medical aluminum foil printing equipment. Together with the author's work practices, this paper discusses with peers and aims to introductory ideas. Work better.
1. Pharmaceutical packaging aluminum foil printing plant and facility requirements.
1.1 The design requirements for the plant. The layout of the plant's size and structure should be reasonable. The production area should be separated from the living area. The requirements for cleanliness of the production area should be met. The temperature and relative humidity should be compatible with the requirements of the aluminum foil printing process. Toilets that meet sanitary requirements should be provided, as well as hand washing, changing and disinfecting facilities. . Plants and warehouses shall have measures to prevent the entry of insects, birds, and rodents. The walls and ceiling surfaces of the rooms shall be smooth and flat, non-ash, corrosion-resistant, impact-resistant, easy to clean, and less concave and convex surfaces. The walls shall be connected to the ground. Should make a radius greater than 50mm rounded corners.
1.2 Design of air purification facility for aluminum foil printing and coating operation room. The standard for indoor clean-up of packaging materials directly in contact with drugs is: the cleanliness is 100,000; the number of air changes in the clean room is 15 per hour; and the amount of fresh air is guaranteed, and the value should be the maximum value of air volume, generally 100,000. 10%-30% of the total volume of vertical non-unidirectional flow cleanrooms, 2%-4% of the flow rate of one-way flow cleanrooms, compensation for indoor exhaust air and the amount of fresh air needed to maintain positive indoor pressure values, guaranteed The amount of fresh air per person per hour in the room is not less than 4Omm3. Therefore, according to the requirements of the purification standards, the basic design of the indoor airflow pattern system consists of three parts: first, the appropriate airflow pattern should be designed; secondly, the form, size, and layout of the return air inlet should be determined; and thirdly, Calculate the air jet parameters. The following principles are followed in the design: 1 Prevent dust particles from flying twice as much as possible to reduce the chance of dust particle contamination on the process; 2 Minimize vortex flow to avoid dust particles outside the clean area from entering clean areas; 3 Clean areas The air speed should meet the requirements of air clarity and human health, and make the air flow to a single direction. The way to send clean air indoors is generally to choose a high-efficiency filter with a diffuser to set the return air from the top of the room, while the air supply is a unilateral lower air outlet.
1.3 Positive pressure control in the aluminum foil printing operation room. Operation Clean air infiltration is one of the ways to pollute the clean room. In order to prevent the infiltration of the surrounding air, a certain positive pressure must be maintained in the clean room, and the positive pressure in the clean room is achieved by making the indoor air supply volume greater than the return air volume and the exhaust air volume. Although a large positive pressure value is good for preventing the infiltration of air outside the clean room, it will also shorten the service life of the high-efficiency filter due to the increase in the amount of fresh outdoor air required, and it will also make it difficult to open the room door. Therefore, the positive pressure value should not be too large, the general indoor should maintain a positive pressure value of 10Pa-20Pa.
1.4 The layout of people, logistics and equipment in the room. The logistics in the room (the direction of raw materials, semi-finished products or finished products) and the flow of people (operators' access) must not be mixed, and each individual should be allowed to avoid cross-contamination. There should be men's and women's locker rooms, buffer rooms, raw material rooms, semi-finished product storage rooms, finished product storage rooms, and product inspection rooms. Aluminum foil printing equipment and supporting machinery should enable logistics to run in a certain direction to prevent errors during operation. Equipment and ancillary machinery must have sufficient site and semi-finished products to have a set management card.
1.5 Design principles for preventing cross-contamination of aluminum foil materials. Sources of cross-contamination often come from harmful gases, microorganisms, or workers’ clothing during operation. The severity of cross-contamination varies depending on the type of pollution. Cross-pollution sources should be minimized during design. The design principles for preventing cross-contamination are: 1 products should be produced or packaged in isolated areas; 2 in the effective isolation area to avoid the simultaneous production of different products; 3 clean room equipment should pay attention to cleaning, remove the pollution source, while handling the raw materials should be sealed In the environment; 4 pay attention to the recycling of untreated air or exhaust gas should no longer invade the clean room.
1.6 Preparation of process facilities construction design documents. According to the design ideas of the above aluminum foil printing process equipment and facilities, work plans for the relevant facilities are compiled. Generally include: 1 aluminum foil printing and coating process layout layout design; 2 equipment installation foundation construction design and plane position installation diagram; 3 equipment piping (power medium pipeline) to the design diagram; 4 purification facilities sent to the wind plane layout Figure design; 5 purification facilities send, return, exhaust duct system axonometric design; 6 overall design and construction instructions; 7 power medium (electricity, water compressed air) station location design and outdoor piping design drawings.
2. Pharmaceutical aluminum foil printing and coating equipment performance, structure, configuration options
2.1 performance parameters required. 1 Medicinal aluminum foil printing width. In general, the wider the format, the higher the productivity, but the investment is relatively large. The current width is 600mm, 700mm, 800mm. The width of the printing press is selected based on the width of the aluminum foil packaging required by the pharmaceutical blister packaging machine, leaving a certain margin for slitting. The printing speed of 2 printing and coating machine, it is the main parameter that measures the grade of printing machine. General domestic machine printing speed, simple low-grade 20m/min-35m/min, mid-range printing press speed 50m/min-70m/min, high-grade up to 80m/min-100m/min. After determining the speed and width, color and parameters of the printing press, the investment in its equipment was determined accordingly. 3 printing color number: printing machine has a single color, two-color, multi-color (more than 3 colors). In recent years, there are 3 colors to 4 colors. 4 Printing register accuracy: This indicator is also the main parameter to measure the quality of the printing press. If some equipment does not have a registration system, its printing accuracy is about +/- 0.5mm. Domestic printers with automatic register accuracy system can print +/- 0.2mm~+/- 0.25mm. (5) The parameters selected by the printing press include: the maximum diameter of the discharge and take-up reels, the diameter of the printing plate roller, the heating mode and the power of the entire motor, the amount of cold water consumed, the amount of compressed air, and the external shape of the machine. The total weight of the equipment should be considered carefully.
2.2 device configuration requirements. Different grades of aluminum foil printers have different configurations. The configuration of low-grade monochrome printers is: 1 unwinding station → printing station → drying → coating protective agent station → drying → winding station. 2 unwinding station → coating adhesive station → drying → winding station → cutting. Since the drying tunnel is a single layer, it requires secondary processing to complete the entire process, so the yield is low. Another configuration is the unwinding station→the printing station (3 colors to 4 colors) drying→coating agent→drying→coating adhesive station→drying→coiling station→division. Because of the use of a double-decked drying tunnel, the processing is completed at one time, so the production efficiency is high.
2.3 Configuration requirements of the device structure. 1 tension control system: This system is the core of pharmaceutical aluminum foil printing and coating equipment. The unwinding traction magnetic powder brake is used for the unwinding station in general equipment, and the magnetic powder clutch is used for the rewinding station aluminum foil winding. The tension is detected by a tension sensor mounted on the guide roller. 2 automatic correction system: For aluminum foil in the operation of the correction is to use photoelectric scanning head tracking correction, scanning head can be manually adjusted according to different positions. Pneumatic scan heads are usually used for tracking corrections in transparent materials. 3 Drive system of printing, coating and station: In order to improve the running accuracy of the whole machine, variable frequency motors are used in the printing, coating and winding stations, and the gear box is driven by helical gears. When the machine is in the process of increasing the speed, the equipment will increase the speed to the required value at the preset optimal rate, ensuring multiple sets of accuracy. 4 automatic registration system: For printing multi-color printing equipment with a speed of more than 50m/min, automatic registration system must be configured. The principle is that all subsequent color groups are tracked and registered according to the previous color's gauge line.
2.4 Configuration of auxiliary equipment. 1Air Compressor: In the foil printing and coating process, compressed air is used as the working medium to supply the gas pressure required by the pneumatic components. The compressor used is generally a reciprocating piston type. When selecting the air compressor, the installation capacity of the air compressor should be ensured that when the maximum one air compressor is inspected, the total capacity of the remaining air compressors is not less than the design consumption. The design consumption of compressed gas can be calculated on the basis of the theoretical average gas consumption of the equipment provided, and its formula is Q=ΦΚ(I+Ψ)ΣQ cubic meters/minute. Where: Q is the design consumption of compressed air; Φ is the altitude correction factor, Ψ is the leakage coefficient of pipeline equipment; and ΣQ is the sum of the theoretical average volume of equipment in the same compressed air supply system. K is the ratio of the maximum air consumption to the average air consumption. 2 Refrigeration equipment and cooling water consumption: Since the aluminum foil printing reel has cooling water in it to rapidly cool the high-temperature dried aluminum foil through the drying tunnel, refrigeration equipment is required to supply cooling water. In addition, the printing temperature and humidity are strictly required. The building is equipped with cold air and cooling water.
At present, the refrigeration methods used for cold equipment include ammonia compression refrigeration, vapor injection refrigeration, and lithium bromide absorption refrigeration. Each of the three cooling methods has its own advantages and disadvantages. Reasonably choose the configuration according to different situations. Design of refrigeration equipment: The choice of cold water load can be calculated according to the requirements for the cooling water consumption, temperature rise and supplementary water temperature provided by each equipment: Q=AC (ΣG1×Δt1+ΣG2×ΔΔt2) kcal/hour. In the formula: Q is the designed cold water load, A is the cold loss coefficient; C is the specific heat of water 1000 kcal/ton °C Σ G1 is the total circulating water quantity of low-temperature cooling water used by the same type of equipment at the same time; Σ G2 is the total amount of supplementary water, That is, the sum of the low temperature water consumption that cannot be recovered and the amount of circulating water added water (ton/hour); Δt1 is the temperature rise (°C) of the low-temperature cooling water circulation process; Δt2 is the temperature difference (°C) between the make-up water and the low-temperature cooling water.