Moulded Injection Vials Type I,II,III
Subcategory:
Moulded Injection vial, type I,II,III
Moulded Injection Vials Type I,II,III
Available Format: sizes from 5ml to 100ml, meet all requirements specified in the latest version of norm of CFDA YBB, USP, EP.
Color: Clear and Amber;
Glass type: made of sodalime glass or borosilicate glass, including type I, II, III which always are available in stock.
Brief introduction of moulded glass for injection
Glass Type
Glass in its pure form consists of silicon dioxide with a melting point of approximately 1700°. Added network modifiers, such as sodium and potassium oxides or boric oxide are for lowering the melting point, while other network stabilizers, such as calcium and aluminum oxides are for improving the durability of the glass. Colored glass (e.g., amber glass) is produced by transition metal oxides such as iron oxides. All additives to pure silicon dioxide can be viewed as potential extractables in glass.
Glass compositions do not exist at a stoichiometric chemical composition but rather are expressed over a range of compositions. Thus, there is allowable variation within a glass type, and glass types may vary slightly among glass producers. Soda-lime-silica glass consists of silica (60%–75%), sodium and potassium oxides (12%–18%), and smaller amounts of calcium, magnesium, and aluminum oxides (5%–12%). This glass has a relatively high coefficient of expansion (COEs) of 8.4-9.2x10-6K-1 (20-300℃) and is susceptible to damage by thermal shock. Borosilicate glass consists of silica (70%–80%), boric oxide (7%–13%), and smaller amounts of sodium, potassium, and aluminum oxides. The presence of boron provides greater resistance to thermal shock and to hydrolytic attack. Type I glass is available in two formulations: 3.3 glass and 5.1 glass, in reference to their individual COEs of 3.25 × 10-6K-1 (20-300℃) per degree and 5.1 × 10-6K-1 (20-300℃), respectively.
Glass containers for pharmaceutical use
Glass containers for pharmaceutical use are glass articles intended to come into direct contact with pharmaceutical preparations. The hydrolytic stability of glass containers for pharmaceutical use is expressed by the resistance to the release of soluble mineral substances into water under the prescribed conditions of contact between the inner surface of the container or glass grains and water.
The hydrolytic resistance is evaluated by titrating released alkali. According to their hydrolytic resistance, glass containers are classified as follows:
|
Glass Type |
Hydrolytic resistance |
Application |
|
Type I |
Neutral glass, a borosilicate glass containing significant amounts of boric oxide. With a high hydrolytic resistance due to the chemical composition of the glass itself. (moulded glass vial, and tubular vial) |
Suitable for most preparations whether or not for parenteral use(injection use) |
|
Type II |
Soda-lime glass with sulfur treatment, with a high hydrolytic resistance resulting from suitable treatment of the surface of glass vial (only moulded glass vial) |
Suitable for most acidic and neutral, aqueous preparations whether or not for parenteral use. |
|
Type III |
Soda-lime glass, with only moderate hydrolytic resistance (only moulded glass vial). Some factories use amber tubing glass container for oral use. |
Generally suitable for non-aqueous preparations for parenteral use, for powders for parenteral use(not including freeze-dried preparations), and for preparations not for parenteral use. |
Advantage
Our company realizes GMP clean production, complete product series, one-stop supply, and has become the Asia's largest and one of the world top three suppliers of pharmaceutical glass packaging materials
1. Our company produces and supplies all pharmaceutical glass packaging materials under the norms of CFDA / ISO and the requirements specified in the current version of EP and USP.
2. Our products are exported to nearly 92 countries and regions, with the annual export scale of around 200 million USD.
3. It has successively passed relevant system certifications, including ISO15378, ISO9001, ISO14001, ISO45001, FSSC22000.
The pharmaceutical glass we produce almost covers the mainstream product types and specifications required in the market. At the same time, we also produce butyl rubber plugs for injection and related supporting caps.
Certificate
Quality Control
Drastically develop quality certification of ISO9001 quality management system and ISO14001 environmental standard, to form a complete rigorous quality assurance system in the enterprise to meet external and international standards into line. On February 19, 1998, we obtained ISO9002: 94 quality system certification. Passed ISO9001: 2000 quality management system certification On August 25, 2003, and ISO14001: 2000 standard on August 25, 2003.
The company has established a sound market services system, through market services, work to effectively master the understanding of the needs of different customers, to grasp the pulse of the market and maximize the elimination of customer complaints. The implementation of the customer complaints on file system is responsible for each of the customer complaints should have special staff in the end, to achieve the implementation of the rate of customer complaints to 100%.
Equipment
Moulded Injection vial, type I,II,III
keyword:
Moulded Injection Vials Type I,II,III
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