In the design of the hottest plastic flexible pack

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Design of plastic flexible packaging large infusion project (middle)

in the early 1980s, the large infusion factory represented by Otsuka pharmaceutical factory in Japan launched the second generation of large infusion product: plastic bottle large infusion. This kind of packaging has the following characteristics:

1 Bottle making and filling shall be completed in the clean area to avoid intermediate pollution. No bottle washing, water saving, one-time packaging, can not be reused to avoid cross contamination

2. The bottle is light and not fragile, but it has certain falling height restrictions

3. The plastic bottle can be slightly deformed, but the tail still needs to be pierced with an air needle before infusion. Compared with the glass bottle, the pollution is reduced, and pressurized infusion is not allowed

4. In recent years, plastic bottles are made of high molecular polymers. After filling with liquid medicine, there is no dissolution, no debris, and no deterioration of liquid medicine and vascular embolism

5. Generally, the transparency of plastic bottles is poor, which is unfavorable for light inspection

6. There is air in the bottle, and improper infusion will produce air embolism. The liquid medicine sensitive to oxygen should be filled with N2 for protection

7. The high-temperature sterilization bottle will be deformed and can only be sterilized at medium and low temperature (106~117 ℃)

8. Plastic bottles have high water oxygen permeability, which is not suitable for filling amino acid infusion

9. There is only one mouth, which is difficult to add medicine, but it can be added at the tail

10. It can realize all automatic production, but it is difficult to switch infusion of different specifications on the same production line

non PVC multi-layer coextrusion film is composed of PP, PE and other raw materials with physical compatibility. In the late 1980s and early 1990s, it developed rapidly and formed the third generation of infusion. Large infusion manufacturers (such as Fresenius, Braun, Baxter, famasia, Otsuka, Takeda, etc.) with well-known plastic granulators in the world have large infusion products in this form of packaging. Multi layer coextrusion film for large infusion has become a development trend at the end of the 20th century. The packaging material is soft, transparent and the film thickness is small, so the soft packaging can complete the human input of the liquid medicine through its own shrinkage without introducing air, so that the liquid medicine can avoid the pollution of the external air, ensure the safe use of the infusion, and realize the closed infusion. As the third-generation infusion, its main characteristics are as follows:

1. Bag making, printing, filling and sealing are completed on the same production line, and the cylinder membrane is used without washing, so as to avoid pollution in the production process; It is a one-time package and cannot be reused without cross contamination; Recycling has no environmental pollution

soft bag infusion meets the needs of manufacturers, businesses, medical staff and patients. It will replace the old glass bottles and other open infusion in the domestic market and become the main packaging form of large infusion in the future. Therefore, the market prospect is broad

large infusion is a commonly used emergency medicine, which is in great demand in clinic. According to statistics, the per capita consumption of large infusion in developed countries is 3 bottles/year. Based on this calculation, the potential large infusion Market in China is about 3.5 billion bottles/year. At present, the large infusion Market in rural China has not been developed. Only through urban statistics, the per capita consumption of large infusion is only about 1 bottle/year, which shows that there is still a huge market space in China, and the timely development of large infusion industry has broad market prospects

the current situation of the production of large infusion in China is also extremely unbalanced. The vast majority of manufacturers still produce large infusion in traditional glass bottles, and the factory buildings are old and the equipment conditions are simple, which can not meet the requirements of GMP. Now, plastic bag infusion, which integrates bag making, filling, sealing and other processes, has gradually replaced the traditional glass bottle infusion with its advantages of light weight, simplified process, stable quality, strong safety and long validity, and has become a development trend

the infusion manufacturing process and equipment of non PVC composite film packaging are advanced, with high technical content and stable product quality. Compared with glass bottle packaging, it has changed the shortcomings of heavy and fragile packaging containers, difficult transportation and turnover, inconvenient use, high requirements for storage and transportation conditions, and products are prone to quality problems during storage. It is suitable for safe infusion in outdoor and unclean environments. It is widely welcomed by medical staff and is the development direction of international infusion packaging containers today

IV. brief situation of our hospital's design of infusion projects

our hospital is Tianjin Pharmaceutical Design Institute, which has been engaged in pharmaceutical factory design for nearly 40 years (see Annex 1). Many projects designed in recent years have passed GMP certification (see Annex 2). Our institute has designed many large infusion plants (see Annex 3). In terms of the design of soft bag infusion, we have many experiences. Here we communicate with experts, and we also find some noteworthy problems in the design. Here I talk about my views and discuss with experts

v. problems found in the design

some enterprises have not produced drugs, products, engineering and technical personnel before, and there is no production experience and process of infusion when many enterprise users purchase tensile testing machines. Without providing design conditions, they require the design institute to make a general soft bag design. This is very difficult for design institutes that have not made soft bags, but for experienced design institutes, although they can make designs, they may cause losses to Party A due to their blindness and little pertinence. (to be continued)

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