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Glass bottle quality standard

Hangzhou Lecos Packaging Co.,Ltd | Updated: Jun 01, 2018

Standardization system

Standard and standard system for glass bottles

Article 52 of the pharmaceutical administration law of the People's Republic of China stipulates that: "the packaging materials and containers that come into direct contact with pharmaceuticals must meet the medical requirements and safety standards." The pharmaceutical administration law of the People's Republic of China regulations on the implementation of article 44: "direct contact with drugs management method of packaging materials and containers, product catalogue and medicinal requirements and standards, organized by the pharmaceutical supervisory and administrative department under the state council and promulgated." According to the laws and regulations requirements, the state drug administration since 2002 by instalments organization formulated and issued 113 pharmaceutical packaging container (materials) standard (including plans to release 2004 standard), including pharmaceutical glass packaging container (materials) standard 43, standard 38% of the total number of all medicine Bao Village standard, standard scope covers for injection powder injection, ShuiZhenJi, infusion solution, tablet, pill, oral liquid and lyophilization, vaccines, blood products and other kinds of dosage forms of pharmaceutical glass packaging container. A relatively complete and standardized standardization system for the standardization of medical glass bottles has been formed. These standards issued and implemented, the upgrading of medicinal glass packaging container, improve product quality, to ensure drug quality, speed up with international standards and the international market, promote and standardize the Chinese medicine glass industry healthy, orderly and rapid development, has the vital significance and role.

Medicinal glass bottle is direct contact with drugs packaging materials, occupies a large proportion in the field of pharmaceutical packaging materials, and has an irreplaceable performance and advantage, the standard for pharmaceutical packaging quality and has a vital influence industry development.

Medicinal system

Standardization system of medical glass bottles

Formulated in accordance with the state drug administration of drug packaging standard according to the material, a material (varieties) of a standard principle, medicinal glass has been released and published standards, a total of 43. By standard type

Glass bottle

Glass bottle

There are 23 product standards in the first category, of which 18 have been released and 5 are planned to be released in 2004. There are 17 standards for the second type of test methods, of which 10 have been issued and 7 are planned to be issued in 2004. There are three basic standards in the third category, one of which has been issued and two of which will be issued in 2004. 23 the first kind of product standards, according to the product type is divided into eight kinds, including the molding injection bottle 3 "control injection bottle" three "glass infusion bottle" three "die pharmaceutical bottles of" three three control medicine bottles, three control oral liquid bottle, "Ann bottle" two "medicinal glass tube" three (note: this product is for processing all kinds of vials, ampoule semi-finished products).

Materials will be divided into three categories, including eight borosilicate glass, borosilicate glass including alpha = (4 ~ 5) x 10 (6), K (1) (20 ~ 300 ℃) and alpha = neutral glass (2 ~ 3. 3. 4) x 10 (6), K (1) (20 ~ 300 ℃) 3. 3 borosilicate glass. This kind of material for the international neutral glass, also often called Ⅰ glass or first class material. Low eight borosilicate glass, borosilicate glass for alpha = (6. 2 ~ 7. 5) x 10 (6), K (1) (20 ~ 300 ℃). This kind of glass material is China's unique quasi-neutral glass which cannot be connected with international standards. 7 item soda lime glass, soda-lime glass for alpha = (7. 6 ~ 9. 0) x 10 (6), K (1) (20 ~ 300 ℃), such as glass material, generally after the vulcanization process, the surface of the water resistant performance at level 2.

17 second test method standard, and the test method standard covers basic medicinal glass bottles of various kinds of product performance, indicators and other inspection items, especially about the detection of glass chemical properties reference to ISO standards added new water resistance, alkali resistance, acid resistance performance test, in order to make medicinal glass bottles of various products to adapt to the different properties, dosage forms of drugs, the chemical stability of identification provides more and more comprehensive, more scientific testing methods, the detection method to guarantee the quality of medicinal glass bottles, thus ensuring the quality of the drugs will play an important role. In addition, the detection methods for the leaching amount of harmful elements have been added to ensure the safety of medical glass bottles. The standards of inspection methods for medical glass bottles need to be further improved. For example, the quality and application of medical glass bottles are greatly influenced by the test methods of ampoule alkali defoliation, the test methods of breaking force and the test methods of freezing shock.

The third type of basic standards, a total of three items, including the medicinal glass component classification and its test method is a reference to ISO 12775-12775 "the normal mass production of glass according to the component classification and its testing method, for the classification of medicinal glass composition and its test method standard has a clear definition, to distinguish the classification of glass material in other industries. The other two basic standards set limits on the harmful elements of lead, cadmium, arsenic and antimony in glass materials to ensure the safety and effectiveness of all kinds of drugs.

Characteristics of medicinal bottle

Characteristics of the standard for medical glass bottles

Pharmaceutical glass bottle standard is an important branch of pharmaceutical packaging material standard system. Due to the medicinal glass bottles to direct contact with drugs, sometimes for a long time of drug storage, the quality of the medicinal glass bottles medicines has a close relationship with the quality of the relating to the personal health and safety. Therefore, the standards for medical glass bottles have special and strict requirements, which can be summarized as follows:

It is more systematic and comprehensive, which enhances the selectivity of product standards and overcomes the lag of standards on products

New criteria to determine the same product based on the principle of different standards in different material, greatly expand the scope of standard coverage, enhance a variety of new drugs apt performance of different glass and the applicability of the product and selectivity, changed the general standard for the product in the product standard development relative lag.

Covered by the new standards, for example, 8 species of medicinal glass products, each product standards according to the material, the performance is divided into three categories, the first kind of borosilicate glass, the second for low borosilicate glass, the third kind of soda lime glass. Although a certain product of a certain kind of material has not been produced yet, but the standard of this kind of product has been issued, which solves the problem of the lag of making the standard after the product is produced. Drugs of different grades, properties, USES and dosage forms have more flexible and larger choice space for products and standards of different materials.

Definition of borosilicate glass and low borosilicate glass international standard ISO 4802.1-1988 water resistance of the inner surface of glassware and glassware part 1: Use titration method for determination and classification of borosilicate glass (including neutral glass) is defined as containing boron trioxide (B - 2-3) o 5 ~ 13% (m/m) of the glass, but in 1997 published by ISO 12775 "the normal mass production of glass composition classification and its test method are defined in the borosilicate glass (including neutral glass) containing boron trioxide (B - 2-3 o) greater than 8% (m/m). According to the 1997 international standard for classification of glass, the b-220-6% (m/ m) glass materials widely used in China's pharmaceutical glass bottle industry over the years should not be called borosilicate glass or neutral glass. It has been proved that the glass particle method of this kind of material can be used for water resistance and inner surface water resistance tests. Practice also proved that this kind of glass can appear in use some neutral unqualified or take off a piece of phenomenon, but this kind of glass production in China has used for years, the new standard has kept this kind of material of glass and its B - 2-3 o content should be consistent with 5-8% (m/m), clearly define the class cannot be called a borosilicate glass (or neutral glass), and named it low borosilicate glass.

Glass bottle

Glass medicine bottle (9 pieces)

The active adoption of ISO standards, in line with international standards of new standard comprehensive reference to the ISO standard and the United States, Germany, Japan and other advanced countries industrial standards and pharmacopoeia, and according to the reality of the Chinese medicinal glass industry from two aspects: the types of glass and glass material to line with international standards.

Glass material type: The new standard of the communist party of China there are four types of glass, including 2 kinds of borosilicate glass, including 3. 3 borosilicate glass [alpha = (3. 3 + 0. 1) x 10 (6), K (1)] and 5. 0 neutral glass [alpha = (4 ~ 5) x 10 (6), K (1)], low borosilicate glass [alpha = (6. 2 ~ 7. 5) x 10 (6), K (1)] 1, soda-lime glass [alpha = (7. 6 ~ 9. 0) x 10 (6) K (1)] l, So there are four types of glass by material.

As sodium calcium glass in the actual production and application of a large number of neutral surface treatment after a large number of, so divided into 5 products. The four types of glass and five types of glass products mentioned above include international standards, American pharmacopoeia and China's unique types of medical glass bottles. 8 in the products, in addition, standard covers only the ampoule formulated the borosilicate glass ampoule and the low borosilicate glass ampoule, two standard and standard of borosilicate glass ampoule only an alpha = (4 ~ 5) x 10 (6), K (1) 5. 0 borosilicate glass instead of alpha = (3. 3 + 0. 1) x 10 (6), K (1) 3. 3 borosilicate glass, mainly because of the world also have no this kind of product, and (3) 3 the softening point of high borosilicate glass, cause sealed ampule charging more difficult. In fact, the international standard only has a 5.0 borosilicate glass ampoule, instead of a 3.3 borosilicate glass ampoule and a sodium calcium glass ampoule. On China's unique low borosilicate glass ampoule, in the current domestic due to a variety of reasons 5. 0 borosilicate glass ampoule mass has not been formed stable production period, only as a kind of transitional product, eventually to limit with low borosilicate glass ampoule, developing 5. 0 borosilicate glass ampoule, as soon as possible with international standards and products.

Properties of glass material: the thermal expansion coefficient specified in the new standard is magnitude, 3.3 borosilicate glass and 5.0 borosilicate glass are completely consistent with international standards. Low borosilicate glass is unique to China and there is no such material product in international standards. The ISO standard for sodium calcium glass is (8 ~ 10) * 10 (-6) K(-1), and the new standard is (7.6 ~ 9.0) * 10 (-6) K(-1), which is slightly stricter than the international standard. The new standards, (3) 3 borosilicate glass, 5. 0, calcium sodium borosilicate glass and glass particles in 121 ℃ water resistance of the material chemical properties are consistent with international standards. In addition, the above three types of glass are completely in line with international standards for the content of boron oxide (b-2o-3), a chemical component.

Performance of glass products: the performance of the product specified in the new standard is consistent with international standards, including water resistance, thermal shock resistance and internal pressure resistance. The ISO standard for the internal stress index stipulates that ampoules are 50nm/ mm and other products are 40nm/ mm, while the new standard includes that all ampoules are 40nm/ mm, so the internal stress index of ampoules is slightly higher than the ISO standard.

Change of trade mark

Standard content changes to trade standard

The new standard format and the establishment of the project refer to the compilation format of the pharmacopoeia of the People's Republic of China.

The project set out to highlight the content of identification, the thermal expansion coefficient and the content of boron trioxide to define the glass material type. The standard content is clear and focused, and the main performance indicators and the limitation of harmful elements are included in the text as mandatory indicators. Bright and clean level off is defined for appearance index should not have obvious flaws, the product the appearance of the concrete defects such as bubbles, stones, stripes and surface defects can be made of supply and demand in the form of agreement, standard, or contract accessories such as shall be determined. The indicators for the new standard also on the sizes listed in the appendix as recommended projects, to meet the needs of the market diversification and new varieties, new style, but the author thinks that the standard size in the appendix of tolerance should be mandatory, in order to ensure the consistency of the product specifications size tolerance precision and operational performance of the product.

Complete set of standards

The testing project is comprehensive and the supporting testing standards are complete

New standards and ISO standards and related products, compared to foreign relevant product standards testing project comprehensively, mainly to increase the thermal expansion coefficient of determination, determination of the content of B - 2-3 o, to identify the material of glass. Because most of China's pharmaceutical glass products still use arsenic trioxide (As 2 o 3) or compound clarifying agent antimony trioxide (Sb 2 o 3) + arsenic trioxide (As 2 o 3) As clarifying agent of glass system, therefore, the new standard of increased the dissolubility of the harmful elements of set limit to control, to ensure that the drug is safe and effective wrapped up.

The new standard for the product standard of form a complete set of relatively complete testing standards, all indicators in the product standard and the project has a corresponding inspection standards for the selection, important performance test method standard are adopted ISO standard test methods.

Medicinal bottle application

The application of standards for medical glass bottles

All kinds of products and different materials form a standardized system of crosswise interlacing, which provides a sufficient basis and condition for choosing scientific, reasonable and suitable glass containers for various kinds of drugs. The following principles should be followed in the selection and application of different dosage forms, different properties and different grades of all kinds of drugs to the medical glass bottles:

Chemical stability

Good and suitable chemical stability principle

Between used for holding the glass container of drugs and drug should have good compatibility, namely the guarantee on the production, storage and use of the drug can't because of glass container in chemical is not stable, the performance of certain substances between reaction caused by variation of the drug or failure. For example, blood products, vaccines and other high-grade drugs must choose borosilicate glass glass containers, all kinds of strong acid, strong alkali water preparation, especially alkali ShuiZhenJi also should choose borosilicate glass material of glass containers. China's extensive use of low borosilicate glass ampoule for holding water preparation is not suitable, this type of glass to gradually to the 5. 0 glass transition, in line with international standards as soon as possible, to ensure the costumed drugs in use do not take off a piece, not cloudy, not bad.

The use of low borosilicate glass or natrified sodium calcium glass can still meet the requirements of chemical stability for general powders, oral agents and large infusion. The degree of erosion of drugs to glass is generally greater than that of solid liquid and alkaline than that of acid.

Thermal shock

Good and suitable temperature stability

Different dosage forms of drugs in production should be high temperature drying, disinfection sterilization, or low temperature freeze-drying process, which requires the glass container with good resistance to temperature change and appropriate cracking ability. The thermal stability of glass is mainly related to thermal expansion coefficient. The lower the thermal expansion coefficient, the stronger its ability to resist temperature change. For example, many high - end vaccine preparations, biologics and freeze-drying preparations should be selected in general. 3

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