Article 52 of the "People's Republic of China Drug Administration Law" stipulates: "The packaging materials and containers that are in direct contact with drugs must meet the requirements of pharmaceuticals and safety standards." Article 44 of the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" stipulates: "Direct contact The management methods, product catalogs, and pharmaceutical requirements and standards for pharmaceutical packaging materials and containers shall be formulated and announced by the drug regulatory agency of the State Council. According to the requirements of the above-mentioned laws and regulations, the State Drug Administration has organized organizations in phases since 2002. The formulation and publication of 113 pharmaceutical packaging containers (materials) standards (including the 2004 plan release standards), which include 43 standard pharmaceutical glass packaging containers (materials) standards, accounting for 38% of the total standards of all drug packaging villages, The scope of the standard covers pharmaceutical glass containers for injections such as powder injections, water injections, infusions, tablets, pills, oral liquids, and freeze-dried drugs, vaccines, and blood products. A relatively complete and standardized pharmaceutical glass bottle standardization system has been initially formed. The formulation, issuance and implementation of these standards, the upgrading of pharmaceutical glass containers, the improvement of product quality, and the assurance of drug quality, accelerating the convergence with international standards and the international market, and promoting and standardizing the healthy, orderly and rapid development of the pharmaceutical glass industry in China. , has a significant significance and role.
Medicinal glass bottles are packaging materials that are in direct contact with pharmaceuticals. They have a large proportion in the field of pharmaceutical packaging materials and have irreplaceable performance and advantages. Their standards have a crucial influence on the quality of pharmaceutical packaging and the development of the industry.
The standardization system for medicinal glass bottles According to the principle of the State Drug Administration on the formulation of drug packaging materials by materials, a material (variety) a standard principle, there have been 43 standards for the release and pending release of medicinal glass bottles. Divided into three categories according to the standard types, the first category of product standards a total of 23, of which 18 have been released, plans to release 5 in 2004; the second type of test method standards 17, of which 10 have been released, plans to release in 2004 7 Item; The third category of basic standards consists of 3 items, of which 1 item has been published and 2 items will be released in 2004. There are 23 products of the first type, which are divided into 8 types according to the type of product. Among them, 3 bottles of molded injection bottles, 3 bottles of controlled injection bottles, 3 bottles of glass infusion bottles, 3 bottles of molded bottles and 3 tubes of pharmaceuticals There are 3 items in the bottle, 3 items in the "Controlled Oral Liquid Bottle", and 3 items in the "An-bottle" 2 items of "Glass Medication Tube." (Note: This product is a semi-finished product for processing various types of controlled vials and ampoules).
The materials are divided into three categories, among which 8 items are borosilicate glass, and borosilicate glass includes α=(4～5)×10 (-6) K(-1) (20-300°C) neutral glass and α= (3. 2 - 3. 4) × 10 ( - 6) K ( - 1) (20 to 300 ° C) 3. 3 borosilicate glass. This kind of glass material is an international neutral glass, which is usually also called Type I glass or Grade A material. Low-borosilicate glass 8 items, low-borosilicate glass α = (6.2 ~ 7.5) × 10 (-6) K (-1) (20 ~ 300 °C). This type of glass material is a quasi-neutral glass that is unique to China and cannot be integrated with international standards. It is also commonly referred to as grade B material. Soda-lime glass 7 items, soda-lime glass is α = (7.6 - 9. 0) × 10 ( - 6) K ( - 1) (20 - 300 °C), this kind of glass material is generally cured, surface water resistant Level 2 performance.
There are 17 items of the second type of inspection methods. These standards cover basically all kinds of inspection items such as the performance and indicators of various types of medicinal glass bottles. In particular, the testing of chemical properties of glass increases the new water resistance performance in accordance with ISO standards. The detection of alkali resistance and acid resistance can provide more, more comprehensive, and more scientific detection methods for the identification of chemical stability in order to adapt the various types of medicinal glass bottles to drugs with different properties and dosage forms. To ensure the quality of medicinal glass bottles to ensure that the quality of drugs will play an important role. In addition, a method for detecting the amount of leaching of harmful elements has also been added to ensure the safety of drug glass bottles for drug safety. The inspection method standards for medicinal glass bottles need to be further supplemented. For example, the test methods for the alkaline anti-flaking of ampoule, the testing method of breaking force, and the anti-freezing impact testing method all have an important influence on the quality and application of medicinal glass bottles.
There are three basic standards for the third category, including the “Classification and Test Methods for Components of Pharmaceutical Glass Bottlesâ€, which is based on ISO 12775-1997 “Normally Large-scale Production of Glass by Component Classification and Test Methods,†for pharmaceutical glass. The classification of bottle components and their test method standards are clearly defined to distinguish the classification of glass materials in other industries. The other two basic standards define the harmful elements of lead, cadmium, arsenic, and tellurium, respectively, to ensure the safe and effective containment of various types of drugs.
Characteristics of the standard for medicinal glass bottles The standard for medicinal glass bottles is an important branch of the standard system for pharmaceutical packaging materials. As medicinal glass bottles are to be in direct contact with drugs, some still have to be stored for a longer period of time. The quality of medicinal glass bottles is directly related to the quality of medicines, involving personal health and safety. Therefore, the medicinal glass bottle standard has special and strict requirements, summed up in the following characteristics:
It is more systematic and comprehensive. It enhances the selectivity of product standards, overcomes the lagging standards of products, and establishes the principle of different standards for the same product based on different materials determined by the new standard. It greatly expands the scope of standard coverage and enhances the The applicability and selectivity of new drug-specific drugs to different glass materials and different performance products have changed the relative lag of the standards in the general product standards for product development.
For example, among the 8 medical glass products covered by the new standard, the standards for each product are divided into 3 categories according to material and performance. The first category is borosilicate glass, the second category is low borosilicate glass, and the third category is The class is soda-lime glass. Although a product of a certain type of material has not yet been produced, the standard of this kind of product has already been issued, which solves the problem of lagging behind the normal production of products and then setting standards. Different kinds of drugs with different grades, different properties, different uses and dosage forms have more flexible and larger choices for different types of products and standards.
The definition of borosilicate glass and low borosilicate glass is defined by the international standard ISO 4802. 1 - 1988 "Water resistance of interior surfaces of glassware and glass containers - Part 1: Determination and classification by titration". Borosilicate glass (including Glass is defined as glass containing boron trioxide (B-2O-3) in the range of 5-13% (m/m), but ISO 12775 (Classification and Test Method for Normally Large-scale Production of Glass Components) was published in 1997. The definition of borosilicate glass (including neutral glass) containing boron trioxide (B-2O-3) is greater than 8% (m/m). According to the principle of classifying glass in accordance with the 1997 international standards, the B-2O-3 6 % (m/m) or so glass material widely used in the pharmaceutical glass bottle industry in China for many years should not be called borosilicate glass or neutral glass. Tests have shown that the glass particle method water resistance and internal surface water resistance test of this type of material can not reach Level 1 and HC1, or it can be between Grade 1 and Level 2 edges. Practice has also proved that this type of glass in use will appear neutral or off the film, but this type of glass has been produced in China for many years, the new standard retains the glass of this material and provides its B-2O- The content of 3 should meet the requirements of 5 - 8 % (m/m). It is clearly defined that this kind of glass can not be called borosilicate glass (or neutral glass), and it is named as low borosilicate glass.
Actively adopting ISO standards, the new standards in line with international standards fully refer to ISO standards and industrial standards and pharmacopoeia of advanced countries such as the United States, Germany, and Japan, and combine with the reality of China's pharmaceutical glass bottle industry, from glass type and glass material. Meet the international standards.
Glass material type: There are 4 glass types in the new standard, 2 types of borosilicate glass, including 3. 3 borosilicate glass [α=(3. 3 ±0. 1) × 10 ( - 6) K ( - 1) ] and 5.0 neutral glass [α = (4 ~ 5) × 10 (-6) K (-1)], low borosilicate glass [α = (6.2 - 7. 5) × 10 (-6) ) K( - 1) ]1 kinds of soda-lime glass [α= (7.6 to 9.0) × 10 (-6) K (-1)] l kinds, so there are 4 kinds of glass types by material.
Since soda-lime glass includes a large number of neutral surface treatments in actual production and application, it is divided into five types according to the product. The above 4 glass types and 5 glass products include the international standard, the United States Pharmacopoeia, and China's unique medicinal glass bottles. In addition, among the 8 categories of products covered by the standard, only Amnesium has formulated two standards, “Borosilicate Glass Ampoules†and “Low Borosilicate Glass Ampoules,†while the “Borosilicate Glass Ampoules†standard has only one α= (4 to 5). ) ×10 (- 6) K(-1) of 5.0 borosilicate glass without alpha = (3. 3 ±0. 1) × 10 (-6) K (-1) 3. 3 borosilicate glass This is mainly because there is no such product in the world, and the softening point of 5.3 borosilicate glass is relatively high, which makes it difficult to seal the ampoules. In fact, the international standard only has a 5.0 borosilicate glass ampoule, but not 3. 3 borosilicate glass ampoules and soda-lime glass ampoules. Regarding China's unique low-borosilicate glass ampoule, in the current domestic due to various reasons to make 5.0 borosilicate glass ampoule has not yet formed a large-scale stable production of a specific period, can only be used as a transitional product, and ultimately to limit the use of low boron silicon Glass ampoule, development of 5.0 borosilicate glass ampoule, as soon as possible to achieve full integration with international standards and products.
Glass material properties: The coefficient of thermal expansion prescribed in the new standard, 3. 3 borosilicate glass and 5.0 borosilicate glass, both of which are completely in accordance with international standards. Low-borosilicate glass is unique to China, and international standards do not have such materials. The soda-lime glass ISO is defined as α = (8 ~ 10) × 10 (-6) K (-1) and the new standard is defined as α = (7.6 - 9.0) × 10 (-6) K (-1) ), indicators are slightly stricter than international standards. In the new standard, the material chemical properties of 3.3 borosilicate glass, 5.0 borosilicate glass and soda-lime glass at 121 °C by particle method are in line with international standards. In addition, among the above three types of glass, the content of boron oxide (B-2O-3), a chemical component, is completely in line with international standards.
Performance of glass products: The performance of the products specified in the new standard is consistent with the international standards in the indicators of surface water resistance, thermal shock resistance, and internal pressure resistance. The internal stress index ISO standard specifies that the ampoule is 50nm/mm, other products are 40nm/mm, and the new standard includes ampoule is 40nm/mm, so the internal stress of the ampoule is slightly higher than the ISO standard.
The standard format moves closer to the Pharmacopoeia and the standard content changes to a trade-based standard. The new standard format and the establishment of the project are based on the compilation format of the People's Republic of China Pharmacopoeia. The standard name is formulated according to the sequential format of materials, applications, and shapes.
The establishment of the project highlights the content of the identification. The material type of the glass is defined by the coefficient of thermal expansion and the content of boron trioxide. The content of the standard is clearly defined and focused, and restrictions on major performance indicators and harmful elements are included in the text as mandatory indicators. There should be no obvious defects in the appearance and appearance indicators, and the appearance defects of the products such as bubbles, stones, stripes and various defects on the surface can be determined by the supply and demand parties in the form of agreements, standards or contract attachments. The new standard also includes specifications for the specification of dimensions as a recommended item to meet the needs of market diversification, new varieties, and new styling. However, the author believes that the tolerances of specifications in the standard appendix should be mandatory. , To ensure the product specifications dimensional tolerance accuracy and product performance.
Comprehensive testing items, complete supporting testing standards New standards Compared with ISO related product standards and foreign related product standards, the testing items are relatively comprehensive, mainly increasing the coefficient of thermal expansion and the determination of B-2O-3 content to identify the quality of glass. . As China's current pharmaceutical glass bottles still use As2O-3 or composite clarifier Sb-2O-3 + As-2O-3 as a glass melt clarification The introduction of agents, therefore, the new standard adds to the limited control of the amount of the above-mentioned harmful elements dissolved in order to ensure that the packaged drugs are safe and effective.
The testing standards for product standards in the new standard are relatively complete. All the indicators and items in the product standards have corresponding inspection standards for selection. The testing methods for important performance standards adopt the ISO standard testing methods.
Medical glass bottle standard application Various products and different materials form a vertical and horizontal interwoven standardization system, which provides sufficient basis and conditions for the selection of scientific, reasonable and suitable glass containers for various types of drugs. Different types of drugs, different properties and different grades of various types of drugs for the selection and application of medicinal glass bottles should follow the following principles:
Good and appropriate chemical stability principle The glass containers used to hold various types of drugs should have good compatibility with the drugs, that is, ensure that the chemical properties of the glass containers cannot be unstable during the production, storage and use of drugs. Chemical reactions between certain substances cause the variation or failure of drugs. For example, high-grade drugs such as blood preparations and vaccines must be made of glass containers made of borosilicate glass, and various types of water-needling preparations of strong acids and alkalis, and especially those of strong alkalis should also be made of borosilicate glass. At present, the low-borosilicate glass ampoules used in China are not suitable for containing water-needle preparations. Such glass materials should gradually transition to 5.0 glass materials so as to meet international standards as soon as possible to ensure that the medicines they contain are in use. Do not remove the tablet, do not muddy, not degenerate.
For general powder injections, oral drugs, and large infusions, the use of low borosilicate glass or neutralised soda-lime glass can still meet the chemical stability requirements. The degree of erosion of drugs for glass is generally liquid is greater than solid, alkaline is greater than acidic, especially the strong alkali aqueous injection agent has higher chemical performance requirements for medicinal glass bottles.
Good and suitable anti-temperature aggression Different dosage forms of medicines are subjected to high-temperature drying, sterilization and sterilization or low-temperature lyophilization during the production process, which requires the glass container to have a good and appropriate resistance to sudden changes in temperature without bursting. The temperature-resistance of glass is mainly related to the coefficient of thermal expansion, and the lower the coefficient of thermal expansion, the stronger its ability to resist temperature changes. For example, many high-grade vaccine preparations, biological preparations and freeze-dried preparations should generally use 3. 3 borosilicate glass or 5.0 borosilicate glass. When a large amount of low-borosilicate glass produced domestically undergoes drastic changes in the temperature difference, it tends to be prone to bursting and falling out of the bottle. In recent years, China's 3. 3 borosilicate glass has great development, this glass is particularly suitable for freeze-dried preparations, because of its anti-temperature rapid change performance is better than 5. 0 borosilicate glass.
Well-suited mechanical strength Different types of drugs need to withstand certain mechanical shocks in the production process and during transportation. The mechanical strength of the medicinal glass containers is not only related to the bottle type, geometric size, and thermal processing, but also the glass material. Its mechanical strength also has a certain influence, borosilicate glass mechanical strength is better than soda-lime glass.
Conclusion In summary, the implementation of the new standard for medicinal glass bottles will establish a sound and scientific standardization system, accelerate the pace of integration with international standards and the international market, improve the quality of drug packaging materials, ensure the quality of drugs, and promote the industry. Both development and international trade will play a positive role in promoting. Of course, like the entire standard system for pharmaceutical packaging materials, there are still many problems that need to be further improved, improved, and improved in the standard pharmaceutical glass bottle system that has been initially formed, especially to adapt to the rapid development of the pharmaceutical industry and to adapt to the integration of international markets. Claim. In the revision of standards, content and indicators, and the adoption of international standards, and the degree of convergence with the international market, it is necessary to make appropriate adjustments and supplements in the revision period.
Medicinal glass bottles are packaging materials that are in direct contact with pharmaceuticals. They have a large proportion in the field of pharmaceutical packaging materials and have irreplaceable performance and advantages. Their standards have a crucial influence on the quality of pharmaceutical packaging and the development of the industry.
The standardization system for medicinal glass bottles According to the principle of the State Drug Administration on the formulation of drug packaging materials by materials, a material (variety) a standard principle, there have been 43 standards for the release and pending release of medicinal glass bottles. Divided into three categories according to the standard types, the first category of product standards a total of 23, of which 18 have been released, plans to release 5 in 2004; the second type of test method standards 17, of which 10 have been released, plans to release in 2004 7 Item; The third category of basic standards consists of 3 items, of which 1 item has been published and 2 items will be released in 2004. There are 23 products of the first type, which are divided into 8 types according to the type of product. Among them, 3 bottles of molded injection bottles, 3 bottles of controlled injection bottles, 3 bottles of glass infusion bottles, 3 bottles of molded bottles and 3 tubes of pharmaceuticals There are 3 items in the bottle, 3 items in the "Controlled Oral Liquid Bottle", and 3 items in the "An-bottle" 2 items of "Glass Medication Tube." (Note: This product is a semi-finished product for processing various types of controlled vials and ampoules).
The materials are divided into three categories, among which 8 items are borosilicate glass, and borosilicate glass includes α=(4～5)×10 (-6) K(-1) (20-300°C) neutral glass and α= (3. 2 - 3. 4) × 10 ( - 6) K ( - 1) (20 to 300 ° C) 3. 3 borosilicate glass. This kind of glass material is an international neutral glass, which is usually also called Type I glass or Grade A material. Low-borosilicate glass 8 items, low-borosilicate glass α = (6.2 ~ 7.5) × 10 (-6) K (-1) (20 ~ 300 °C). This type of glass material is a quasi-neutral glass that is unique to China and cannot be integrated with international standards. It is also commonly referred to as grade B material. Soda-lime glass 7 items, soda-lime glass is α = (7.6 - 9. 0) × 10 ( - 6) K ( - 1) (20 - 300 °C), this kind of glass material is generally cured, surface water resistant Level 2 performance.
There are 17 items of the second type of inspection methods. These standards cover basically all kinds of inspection items such as the performance and indicators of various types of medicinal glass bottles. In particular, the testing of chemical properties of glass increases the new water resistance performance in accordance with ISO standards. The detection of alkali resistance and acid resistance can provide more, more comprehensive, and more scientific detection methods for the identification of chemical stability in order to adapt the various types of medicinal glass bottles to drugs with different properties and dosage forms. To ensure the quality of medicinal glass bottles to ensure that the quality of drugs will play an important role. In addition, a method for detecting the amount of leaching of harmful elements has also been added to ensure the safety of drug glass bottles for drug safety. The inspection method standards for medicinal glass bottles need to be further supplemented. For example, the test methods for the alkaline anti-flaking of ampoule, the testing method of breaking force, and the anti-freezing impact testing method all have an important influence on the quality and application of medicinal glass bottles.
There are three basic standards for the third category, including the “Classification and Test Methods for Components of Pharmaceutical Glass Bottlesâ€, which is based on ISO 12775-1997 “Normally Large-scale Production of Glass by Component Classification and Test Methods,†for pharmaceutical glass. The classification of bottle components and their test method standards are clearly defined to distinguish the classification of glass materials in other industries. The other two basic standards define the harmful elements of lead, cadmium, arsenic, and tellurium, respectively, to ensure the safe and effective containment of various types of drugs.
Characteristics of the standard for medicinal glass bottles The standard for medicinal glass bottles is an important branch of the standard system for pharmaceutical packaging materials. As medicinal glass bottles are to be in direct contact with drugs, some still have to be stored for a longer period of time. The quality of medicinal glass bottles is directly related to the quality of medicines, involving personal health and safety. Therefore, the medicinal glass bottle standard has special and strict requirements, summed up in the following characteristics:
It is more systematic and comprehensive. It enhances the selectivity of product standards, overcomes the lagging standards of products, and establishes the principle of different standards for the same product based on different materials determined by the new standard. It greatly expands the scope of standard coverage and enhances the The applicability and selectivity of new drug-specific drugs to different glass materials and different performance products have changed the relative lag of the standards in the general product standards for product development.
For example, among the 8 medical glass products covered by the new standard, the standards for each product are divided into 3 categories according to material and performance. The first category is borosilicate glass, the second category is low borosilicate glass, and the third category is The class is soda-lime glass. Although a product of a certain type of material has not yet been produced, the standard of this kind of product has already been issued, which solves the problem of lagging behind the normal production of products and then setting standards. Different kinds of drugs with different grades, different properties, different uses and dosage forms have more flexible and larger choices for different types of products and standards.
The definition of borosilicate glass and low borosilicate glass is defined by the international standard ISO 4802. 1 - 1988 "Water resistance of interior surfaces of glassware and glass containers - Part 1: Determination and classification by titration". Borosilicate glass (including Glass is defined as glass containing boron trioxide (B-2O-3) in the range of 5-13% (m/m), but ISO 12775 (Classification and Test Method for Normally Large-scale Production of Glass Components) was published in 1997. The definition of borosilicate glass (including neutral glass) containing boron trioxide (B-2O-3) is greater than 8% (m/m). According to the principle of classifying glass in accordance with the 1997 international standards, the B-2O-3 6 % (m/m) or so glass material widely used in the pharmaceutical glass bottle industry in China for many years should not be called borosilicate glass or neutral glass. Tests have shown that the glass particle method water resistance and internal surface water resistance test of this type of material can not reach Level 1 and HC1, or it can be between Grade 1 and Level 2 edges. Practice has also proved that this type of glass in use will appear neutral or off the film, but this type of glass has been produced in China for many years, the new standard retains the glass of this material and provides its B-2O- The content of 3 should meet the requirements of 5 - 8 % (m/m). It is clearly defined that this kind of glass can not be called borosilicate glass (or neutral glass), and it is named as low borosilicate glass.
Actively adopting ISO standards, the new standards in line with international standards fully refer to ISO standards and industrial standards and pharmacopoeia of advanced countries such as the United States, Germany, and Japan, and combine with the reality of China's pharmaceutical glass bottle industry, from glass type and glass material. Meet the international standards.
Glass material type: There are 4 glass types in the new standard, 2 types of borosilicate glass, including 3. 3 borosilicate glass [α=(3. 3 ±0. 1) × 10 ( - 6) K ( - 1) ] and 5.0 neutral glass [α = (4 ~ 5) × 10 (-6) K (-1)], low borosilicate glass [α = (6.2 - 7. 5) × 10 (-6) ) K( - 1) ]1 kinds of soda-lime glass [α= (7.6 to 9.0) × 10 (-6) K (-1)] l kinds, so there are 4 kinds of glass types by material.
Since soda-lime glass includes a large number of neutral surface treatments in actual production and application, it is divided into five types according to the product. The above 4 glass types and 5 glass products include the international standard, the United States Pharmacopoeia, and China's unique medicinal glass bottles. In addition, among the 8 categories of products covered by the standard, only Amnesium has formulated two standards, “Borosilicate Glass Ampoules†and “Low Borosilicate Glass Ampoules,†while the “Borosilicate Glass Ampoules†standard has only one α= (4 to 5). ) ×10 (- 6) K(-1) of 5.0 borosilicate glass without alpha = (3. 3 ±0. 1) × 10 (-6) K (-1) 3. 3 borosilicate glass This is mainly because there is no such product in the world, and the softening point of 5.3 borosilicate glass is relatively high, which makes it difficult to seal the ampoules. In fact, the international standard only has a 5.0 borosilicate glass ampoule, but not 3. 3 borosilicate glass ampoules and soda-lime glass ampoules. Regarding China's unique low-borosilicate glass ampoule, in the current domestic due to various reasons to make 5.0 borosilicate glass ampoule has not yet formed a large-scale stable production of a specific period, can only be used as a transitional product, and ultimately to limit the use of low boron silicon Glass ampoule, development of 5.0 borosilicate glass ampoule, as soon as possible to achieve full integration with international standards and products.
Glass material properties: The coefficient of thermal expansion prescribed in the new standard, 3. 3 borosilicate glass and 5.0 borosilicate glass, both of which are completely in accordance with international standards. Low-borosilicate glass is unique to China, and international standards do not have such materials. The soda-lime glass ISO is defined as α = (8 ~ 10) × 10 (-6) K (-1) and the new standard is defined as α = (7.6 - 9.0) × 10 (-6) K (-1) ), indicators are slightly stricter than international standards. In the new standard, the material chemical properties of 3.3 borosilicate glass, 5.0 borosilicate glass and soda-lime glass at 121 °C by particle method are in line with international standards. In addition, among the above three types of glass, the content of boron oxide (B-2O-3), a chemical component, is completely in line with international standards.
Performance of glass products: The performance of the products specified in the new standard is consistent with the international standards in the indicators of surface water resistance, thermal shock resistance, and internal pressure resistance. The internal stress index ISO standard specifies that the ampoule is 50nm/mm, other products are 40nm/mm, and the new standard includes ampoule is 40nm/mm, so the internal stress of the ampoule is slightly higher than the ISO standard.
The standard format moves closer to the Pharmacopoeia and the standard content changes to a trade-based standard. The new standard format and the establishment of the project are based on the compilation format of the People's Republic of China Pharmacopoeia. The standard name is formulated according to the sequential format of materials, applications, and shapes.
The establishment of the project highlights the content of the identification. The material type of the glass is defined by the coefficient of thermal expansion and the content of boron trioxide. The content of the standard is clearly defined and focused, and restrictions on major performance indicators and harmful elements are included in the text as mandatory indicators. There should be no obvious defects in the appearance and appearance indicators, and the appearance defects of the products such as bubbles, stones, stripes and various defects on the surface can be determined by the supply and demand parties in the form of agreements, standards or contract attachments. The new standard also includes specifications for the specification of dimensions as a recommended item to meet the needs of market diversification, new varieties, and new styling. However, the author believes that the tolerances of specifications in the standard appendix should be mandatory. , To ensure the product specifications dimensional tolerance accuracy and product performance.
Comprehensive testing items, complete supporting testing standards New standards Compared with ISO related product standards and foreign related product standards, the testing items are relatively comprehensive, mainly increasing the coefficient of thermal expansion and the determination of B-2O-3 content to identify the quality of glass. . As China's current pharmaceutical glass bottles still use As2O-3 or composite clarifier Sb-2O-3 + As-2O-3 as a glass melt clarification The introduction of agents, therefore, the new standard adds to the limited control of the amount of the above-mentioned harmful elements dissolved in order to ensure that the packaged drugs are safe and effective.
The testing standards for product standards in the new standard are relatively complete. All the indicators and items in the product standards have corresponding inspection standards for selection. The testing methods for important performance standards adopt the ISO standard testing methods.
Medical glass bottle standard application Various products and different materials form a vertical and horizontal interwoven standardization system, which provides sufficient basis and conditions for the selection of scientific, reasonable and suitable glass containers for various types of drugs. Different types of drugs, different properties and different grades of various types of drugs for the selection and application of medicinal glass bottles should follow the following principles:
Good and appropriate chemical stability principle The glass containers used to hold various types of drugs should have good compatibility with the drugs, that is, ensure that the chemical properties of the glass containers cannot be unstable during the production, storage and use of drugs. Chemical reactions between certain substances cause the variation or failure of drugs. For example, high-grade drugs such as blood preparations and vaccines must be made of glass containers made of borosilicate glass, and various types of water-needling preparations of strong acids and alkalis, and especially those of strong alkalis should also be made of borosilicate glass. At present, the low-borosilicate glass ampoules used in China are not suitable for containing water-needle preparations. Such glass materials should gradually transition to 5.0 glass materials so as to meet international standards as soon as possible to ensure that the medicines they contain are in use. Do not remove the tablet, do not muddy, not degenerate.
For general powder injections, oral drugs, and large infusions, the use of low borosilicate glass or neutralised soda-lime glass can still meet the chemical stability requirements. The degree of erosion of drugs for glass is generally liquid is greater than solid, alkaline is greater than acidic, especially the strong alkali aqueous injection agent has higher chemical performance requirements for medicinal glass bottles.
Good and suitable anti-temperature aggression Different dosage forms of medicines are subjected to high-temperature drying, sterilization and sterilization or low-temperature lyophilization during the production process, which requires the glass container to have a good and appropriate resistance to sudden changes in temperature without bursting. The temperature-resistance of glass is mainly related to the coefficient of thermal expansion, and the lower the coefficient of thermal expansion, the stronger its ability to resist temperature changes. For example, many high-grade vaccine preparations, biological preparations and freeze-dried preparations should generally use 3. 3 borosilicate glass or 5.0 borosilicate glass. When a large amount of low-borosilicate glass produced domestically undergoes drastic changes in the temperature difference, it tends to be prone to bursting and falling out of the bottle. In recent years, China's 3. 3 borosilicate glass has great development, this glass is particularly suitable for freeze-dried preparations, because of its anti-temperature rapid change performance is better than 5. 0 borosilicate glass.
Well-suited mechanical strength Different types of drugs need to withstand certain mechanical shocks in the production process and during transportation. The mechanical strength of the medicinal glass containers is not only related to the bottle type, geometric size, and thermal processing, but also the glass material. Its mechanical strength also has a certain influence, borosilicate glass mechanical strength is better than soda-lime glass.
Conclusion In summary, the implementation of the new standard for medicinal glass bottles will establish a sound and scientific standardization system, accelerate the pace of integration with international standards and the international market, improve the quality of drug packaging materials, ensure the quality of drugs, and promote the industry. Both development and international trade will play a positive role in promoting. Of course, like the entire standard system for pharmaceutical packaging materials, there are still many problems that need to be further improved, improved, and improved in the standard pharmaceutical glass bottle system that has been initially formed, especially to adapt to the rapid development of the pharmaceutical industry and to adapt to the integration of international markets. Claim. In the revision of standards, content and indicators, and the adoption of international standards, and the degree of convergence with the international market, it is necessary to make appropriate adjustments and supplements in the revision period.
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