Краткий анализ стандартов стеклянных контейнеров для упаковки фармацевтической продукции

[ppzhan Abstract] Nothing can be accomplished without norms or standards. To promote the development of the industry, the setting of industry standards is necessary. In recent years, the pharmaceutical packaging industry has continued to develop, and people have put forward different requirements for pharmaceutical packaging; in this process, the industry standards for pharmaceutical packaging have also been continuously improved. Let us take a look at the standards for pharmaceutical glass.

China currently has 24 standards for pharmaceutical glass, including 19 national standards, 5 industry standards, 9 product standards, and 15 test methods and related standards. As far as the current pharmaceutical glass standards are concerned, the problem of excessive standard age is widespread: most were formulated in the 1980s or 1990s, seriously lagging behind the development of the industry and products. The degree of adoption of standards is poor, with most standards being non-equivalent adoptions and other {TodayHot} problems. After joining the WTO, the pharmaceutical glass industry and its products must align with international standards, and standards must be reformed first.

Take pharmaceutical glass product standards as an example; there are currently 9 standards. With the development of the market, the structure and use of pharmaceutical glass bottles have undergone fundamental changes, the consumption of some varieties has become smaller and smaller, and the relevant standards are no longer appropriate. For example, large-size bottles and wide-mouth bottles used to hold tablets have mostly been replaced by plastic bottles, aluminum foil and other materials; at present the market is dominated by oral liquid preparations mainly used to hold various health-care drugs and nutritional drugs, and these are developing toward serialization and smaller specifications. Threaded tubular glass bottles are mainly used to hold oral medicines such as tablets and powders; with the replacement by new materials such as plastic bottles and aluminum foil, their consumption is gradually decreasing.

"Pharmaceutical Glass Bottles" is one of the pharmaceutical glass product standards with an excessive standard age, and it can no longer meet market demand and the current state of products. Therefore, the National Medical Products Administration has included this product standard in its restriction and revision plan. To adapt {HotTag} to the development of the pharmaceutical industry and the needs of biomedicine and biological preparation drugs, the 2000 edition of the pharmaceutical industry standard, which has not yet been officially published, will refer to related standards.

Testing of pharmaceutical glass

According to product use, the test items for pharmaceutical glass are mainly divided into three major categories: physicochemical properties, specifications and dimensions, and appearance quality. After aligning with pharmaceutical glass standards and test methods, testing of the chemical composition of glass and the leaching content of harmful substances will also be added.

Physicochemical properties are important quality indicators and test items for pharmaceutical glass; they reflect and embody the intrinsic quality of the product and directly affect the quality of medicines. Items belonging to physicochemical property testing include: water resistance, internal stress, internal pressure resistance, thermal shock resistance, freezing resistance, breaking force, acid resistance and alkali resistance, etc.

Water resistance: water resistance is the chemical stability of pharmaceutical glass. Since pharmaceutical glass is a packaging container in direct contact with medicines, it must not cause medicines to deteriorate or become ineffective due to changes in chemical properties within the shelf life of the medicines; therefore, the level of chemical stability is directly related to the quality of medicines.

Water resistance testing is divided into the grain method and the container method; the test principle is to neutralize the content on the surface or inside of the glass container with a certain amount of acid solution. The grain method tests the chemical properties of the glass material, and the test method standards are GB12416.2-1990 "Glass grains - Test and classification of water resistance at 121°C" and GB/T6582 "Grain test and classification of water resistance of glass at 98°C". The container method tests the chemical properties of the inner surface of glass, and the test method standards are GB12416.1-1990 "Test method and classification of water resistance of pharmaceutical glass containers" and GB/T4548-1995 "Test method and classification of water attack resistance of the inner surface of glass containers".

In addition, to align with the standards, a draft national standard has been formulated: "Determination and classification of water attack resistance of glass products and glass containers by flame spectrometry". This standard can quantitatively determine the substances released by water resistance on the glass surface and the amount released.

Internal stress: internal stress is the annealing quality or annealing characteristic of glass. Glass containers with poor annealing quality are prone to breaking or shattering during use, affecting the filling of medicines and medication safety. The commonly used standard for testing internal stress is GB12415-1990 "Inspection method for internal stress of pharmaceutical glass containers"; the test principle is to determine the internal stress in the glass container by the optical path difference at different wavelengths, and the currently commonly used instrument is the LRR-8 digital quantitative stress tester.

Internal pressure resistance: internal pressure is an item for measuring the comprehensive strength of glass containers; the internal structure of the glass, the unevenness of the glass wall thickness and surface appearance defects all affect the strength of the glass. The test method standard is GB/T4546-1998 "Test method for internal pressure resistance of glass bottles and jars", and the commonly used testing instrument is the TYJ-B linear pressurization internal pressure testing machine.

Thermal shock resistance: thermal shock resistance tests the ability of glass containers to resist temperature changes and is generally expressed by the temperature difference they can withstand. The test method standard is GB4547-1991 "Test methods for thermal shock resistance and thermal shock endurance of glass containers". The commonly used testing instrument is a digital self-controlled temperature thermal shock tester.

Freezing resistance: freezing resistance is a test item for measuring the low-temperature performance of glass, mainly used for the inspection of glass bottles for lyophilized preparations; the testing instrument is a freezer at below -43°C.

Breaking force: breaking force is an item for testing the easy-break performance of ampoules and is also an important indicator for measuring the usability of ampoules. The commonly used testing instrument is the ZLY-2000 digital breaking force tester.

Acid and alkali resistance: acid and alkali resistance is an item for measuring the chemical stability of glass; the test methods are GB6582-1986 "Method for determination of hydrochloric acid attack on glass at 100°C by flame emission or atomic absorption spectrometry", GB/T15728-1995 "Gravimetric test method and classification for resistance of glass to boiling hydrochloric acid attack", and GB/T6580-1997 "Test method and classification for resistance of glass to mixed aqueous solutions". The main testing instruments include: flame photometer, atomic absorption spectrometer and routine laboratory instruments.

Specifications and dimensions are the main forming process quality of pharmaceutical glass; consistent and stable specifications and dimensions are the basis of pharmaceutical packaging production and have a great influence on the filling, sealing, storage and use of medicines.

Geometric dimensions: the geometric dimensions of the bottle mouth and all parts of the bottle body are generally measured with digital electronic calipers, vernier calipers or height gauges and other measuring tools.

Bottle wall, bottle bottom and bottle mouth thickness: commonly used measuring instruments include digital electronic bottle bottom and wall thickness measuring instruments and digital electronic bottle mouth edge thickness measuring instruments.

Vertical axis deviation: a test item for the verticality of bottles. The test method standard is GB8452-1987 "Glass containers - Test method for vertical axis deviation of glass bottles", and the measuring instrument is the ZPY-10 digital axis deviation measuring instrument.

Straightness: straightness is a test item for the degree of bending of glass tubes. The commonly used measuring instrument is the LSR-1000 digital glass tube straightness tester.

Weight and capacity: weight and capacity testing uses the weighing method and titration method to measure the weight and volume of bottles.

Appearance quality is an item for testing various surface defects of glass containers, mainly including: stones, bubbles, striae, bubble lines, cracks, seams, etc. Appearance quality items are generally tested by visual inspection or measurement with a graduated magnifying glass.

Chemical composition and harmful substance content

Testing of chemical composition and harmful substance content is an important test item for improving the quality level of pharmaceutical glass containers and aligning with international levels.

The soon-to-be-issued pharmaceutical industry standard "Classification of pharmaceutical glass compositions and their test methods" is a non-equivalent adoption of ISO12775-1997 "Glass - Classification by composition and test methods for glass in normal large-scale production"; this standard provides clear classification and provisions for the composition, material requirements, performance and application scope of various types of pharmaceutical glass.

In the raw materials for pharmaceutical glass production, As2O3 and Sb2O3 are often introduced into the glass composition as fining agents; the standards have provisions on the release amounts of these substances, and China is currently formulating relevant control and testing standards to limit harmful elements from the perspective of safety and hygiene.

——This article is reprinted from China Packaging Network (pack.cn). Original link: http://news.pack.cn/show-361851.html