Development of Medical Glass Packaging in China
Year:2009 ISSUE:3
COLUMN:INORGANICS
Click:189    DateTime:Jan.21,2009
Development of Medical Glass Packaging in China       

Medical glass industry, a major branch of medical packaging, is developing rapidly in China.   

1. Antibiotic powder injection    

Antibiotic powder injection is one of the 'five dosage forms' and the consumption of antibiotics is the largest among all kinds of conventional drugs. Molded and tube-type glass bottles are the most preferred packaging materials for antibiotics due to their irreplaceability.
  
Molded antibiotic bottle:    

Its basic chemical compositions are sodium calcium silicate glass, boron-free or low-boron neutral materials. Since the basic oxide (R2O) content in glass is generally below 13%, and its surface has under gone sulfur treatment, the bottle is widely used as packaging material (accounting for about 70% of all antibiotics ) for antibiotics-like powder injections due to its excellent chemical stability. Moreover, three out of the "four antibiotic packaging giants," i.e. Harbin Pharmaceutical Group, Shandong Lukang Pharmaceutical Group and Shijiazhuang Pharmaceutical Group generally use this kind of bottle.
    Currently, there are 10 molded antibiotic bottle manufacturers in China with a total annual capacity of more than 10 billion pieces. Most of the enterprises produce less than 5 million pieces each year, limited by their equipment and product quality - way behind the international advanced level. Lightweight products have not yet been fully realized. More and more often, the traditional 800 000 units of penicillin are packaged in a high dosage. The emergence of special drugs and high-grade drugs, as well as the competition from tube-type bottles, all propel the development of molded antibiotic bottles toward light weight, high-quality and large doses.

Tube-type antibiotic bottle:   

It can also be used in the packaging of antibiotic powder injections. In China, North China Pharmaceutical Group Corp. consumes the most tube-type bottles, about 1.2 billion pieces per year. Developing rapidly in recent years, this product has gradually taken the place of ampoules containing the lyophilized injections and partially replaced molded bottles. As secondary processed products, the quality of tube-type bottles depends greatly on the manufacturing process, and more importantly, on the quality of the glass. However, many manufacturers in China have no capability of drawing pipe and they cannot produce the necessary tubes now. Also, there is a gap between the quality of domestic glasses and similar international products, in their physical and chemical properties. The B2O3 content in the glass of tube-type bottles is generally above 10% in more developed countries, while in China it is only 2% to 7%. Moreover, Chinese product standards, product texture and packaging quality fall short of the international advanced level of similar products.
    In view of the development trend of antibiotic powder injection packaging at home and abroad, the direction of its future development will be to improve glass material, strengthen bottle hardness, enhance specifications for stability, and improve its appearance and packaging quality as well as produce tube-type bottles with a low expansion coefficient and high-quality printing.
    According to market research analysis and forecasts, about 10% to 15% of injections need acid-, alkali- and light-resistant ampoules, and about 5% of the ampoules need high-quality printing at in China at present.
     Analyzed in terms of the market status quo and development needs at home and abroad, the output of tube-type bottles will gradually rise but the molded bottles will still occupy a dominant position.

2. Liquid injection     

Liquid injection packaging mainly adopts glass ampoules. At present, a lot of ampoules which are supposed to be broken easily are hard to break, because Chinese product quality standard is low and the wall thickness and breaking force index of ampoules fail to meet the requirements. Meanwhile, some small and medium enterprises and pharmaceutical companies think little of the quality of ampoules and the drug safety, thus encouraging the low-quality and low-price competition situation in ampoule market.

3. Infusion bottle    

At present, the packaging for infusion solution mainly adopts glass infusion bottles, which have good air tightness, transparency, stability and many other advantages. However, repeated use of glass infusion bottles is extremely unsafe. Chinese Pharmacopoeia requires that water resistance of the inner surface of glass bottles used to package injectable infusions must meet the HC1 and HC2-class requirements in the GB12416.1 standard (equivalent to ISO4802). Only two kinds of glass can meet these requirements. The first is type I glass which is borosilicate glass containing 10% B2O3. It has excellent chemical stability, but there are no infusion bottles made with this kind of glass in China at present, and hardly any in the whole world. The second is type II glass which is soda lime silicate glass with a treated inner surface. With a thin silicon-rich layer on the inner surface, it can achieve the effect of type I glass and is widely used in the world. At present, about 1/3 of infusion bottles in China are made with this kind of glass while the remaining 2/3 are made with glass containing 2% B2O3 which is neither type I nor type II. Tests prove that the water resistance of type II glass is better than that which is neither type I nor type II. But the only reason for the type II glass having the similar performance with type I glass is that through dealkalization, a very thin silicon-rich layer is formed on its inner surface. If used repeatedly, this silicon-rich layer will be damaged after washing and disinfection, resulting in decreased performance. Therefore, the national standard GB2639 makes it clear that type II glass can be used only to make one-time infusion bottles.
   At present, domestic infusion bottles still lag far behind similar international products in weight, cleanliness, packaging transparency, uniformity, etc.

4. Influence from the development trends of the pharmaceutical industry    

In recent years, China's pharmaceutical industry has developed quickly. Three irreversible factors, i.e. total population growth, ageing of population, and rural-urban movement, are the basic conditions for the domestic pharmaceutical market to grow steadily. Also, the vast rural pharmaceutical market will provide tremendous business opportunities for generic drugs like antibiotics.
   As a relatively large producer of crude drugs, China has continuously exported a large number of antibiotics. Its demand for imported drugs is also affected, with imported antibiotics suffering most and market shares engulfed by domestic and joint venture medicines. Coupled with some other factors, such as the high proportion of antibiotic use in Asian developing countries caused by prevalent abuse of antibiotics, generic antibiotics will continue playing a leading role for a long time to come due to their high quality and low price, suiting to the needs of 1.3 billion Chinese people. Therefore, the demand for the glass bottles containing antibiotic medicines will continue to go up steadily. With social progress, the proportion of all kinds of new medicines, special medicines, and high-grade precious medicines will increase gradually, too. These medicines will speed up the upgrade of medical packaging glass, thus enhancing the added value of medical glass packaging products.  
   
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