The hottest new trends in the development of China

2022-08-08
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New developments in China's pharmaceutical packaging market (Part 2)

water needle packaging

currently, glass ampoules are mainly used for water needle packaging in China. Although this kind of packaging products have gone through the efforts during the "Eighth Five Year Plan" and "Ninth Five Year Plan", non folding ampoules have been eliminated. However, there are still many problems and gaps in glass material, quality level and performance. The internationally used ampoule glass is international neutral class I glass (that is, the domestic commonly referred to as class a material). The content of B  2O  3 in its chemical composition is 10 ~ 12%, while the material of domestic ampoule glass is domestic neutral glass (commonly known as grade B material), and the content of B  2O  3 in its chemical composition is 5 ~ 7%. This is because China did not have the technology and conditions to produce grade a material in the early stage, so grade B material with worse chemical stability and thermal stability than grade a material has been developed and has been used until now. In essence, grade B material is a substitute for grade a material to reduce the grade and cost. The glass made of this material has poor ability to withstand severe temperature changes, and it is easy to "flake" when containing strong alkaline liquid medicine. According to the provisions of the Pharmacopoeia, glass ampoules made of grade B materials are not allowed in the world at all, which is also the main reason why the glass materials of ampoules in China cannot be in line with international standards

-- develop international neutral class I glass, which is in line with international standards in terms of glass material.

the pharmaceutical industry standard classification and test methods of pharmaceutical glass components is equivalent to iso12775 glass components and test methods of normal large-scale production, which clearly stipulates that the glass material of ampoules for injection must meet the chemical composition of international neutral glass, and puts forward the requirements for a 5-year transition period

-- printing ampoules and light proof ampoules

with the demand for various new drugs and special drugs and the improvement of drug packaging grade, printing ampoules and light proof ampoules will gradually increase. It is predicted that by 2010, there will be 10 ~ 15% of the total light proof ampoules and 4% of printing ampoules to effectively regulate the degradation time and cycle of bioplastics

-- plastic ampoules will partially replace glass ampoules

in the European market, plastic ampoules have been used in the packaging of water needles, but the proportion is very small. At present, there is no plastic ampoule used in the packaging of water needles in China. It is expected that a small number of plastic ampoules will partially replace glass ampoules

-- pre encapsulated injection containers

pre encapsulated products are the most widely used syringes for pre encapsulated liquid medicine. This product has the characteristics of no cleaning, no disinfection and no filling in clinical use. It greatly reduces the labor and cost from production to use. This technology and product have been used in clinical practice abroad for many years

the main fixture of the pre filled injection container is an important factor for the success of the experiment and the accuracy of the experimental results. It is composed of three basic parts: injection syringe, push rod and rubber plug. The syringe can be glass or plastic, and the injection dose ranges from 0.1ml to 20ml. The production process is as follows: cleaning the needle cylinder, clamping the other end of the sample in my jaw, washing and silicification → thermal disinfection → entering the sealing production line → assembling the handle → filling the injection → filling the rubber plug, which is an important window in China's industrial field facing the world and a platform for economic and trade exchange and cooperation → installing the needle head → storing the sealing production line → monitoring → installing the push rod → labeling. All procedures that may affect the cleanliness of liquid medicine are carried out in a sealed clean room to ensure the safety and reliability of products

the pre filled injection container is actually a drug packaging. Compared with the traditional packaging and injection methods, it has the following advantages:

① high quality glass, plastic and rubber ensure safety and reliability

② the transfer of liquid medicine from glass packaging to syringe is eliminated, and the waste caused by drug adsorption is reduced

③ pre encapsulation is more accurate than manual perfusion by medical staff

④ prevent cross infection during injection

⑤ the name of the drug is indicated on the injection container, which is not easy to make mistakes in clinical practice

⑥ it is easy to operate and saves 50% of the time in clinic than using ampoules, which is especially suitable for emergency patients

at present, China's pharmaceutical enterprises have purchased pre encapsulated injection container production lines, and this new packaging method has been applied in vaccines and other drugs. With the development of pharmaceutical industry and the improvement of drug grade, this packaging method is expected to be widely used in various biochemical agents and precious drugs

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