Стандарты и испытания идут в ногу со временем, обеспечивая безопасность фармацевтической упаковки

[ppzhan Abstract] Industry standards play an important role in the development of an industry; as the saying goes, "nothing can be accomplished without norms or standards". The continuous development of the packaging industry now makes the regulation of industry standards even more necessary in order to promote the healthy development of the industry. This article gathers the relevant standards for glass packaging in pharmaceutical packaging.

China currently has 24 medicinal glass standards, including 19 national standards, 5 industry standards, 9 product standards, and 15 test methods and related standards. As far as the current medicinal glass standards are concerned, the problem of long standard age is widespread; most of them 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, and most standards are non-equivalent adoptions and other {TodayHot} problems. After joining the WTO, the medicinal glass industry and products must be brought in line with international practice, and standards must be reformed first.

Taking medicinal glass product standards as an example, there are 9 existing standards. With the development of the market, the structure and uses of medicinal glass bottles have undergone fundamental changes; the consumption of some varieties is becoming smaller and smaller, and the related standards are no longer appropriate. For example, large-size bottles and wide-mouth bottles used for containing tablets have mostly been replaced by plastic bottles, aluminum foil and other materials. At present, oral liquid preparations used mainly for containing various health-care drugs and nutritional drugs are in the majority, and are developing in the direction of diversification and small specifications. Threaded tubular glass bottles are mainly used for containing oral drugs such as tablets and powders; with the replacement by new materials such as plastic bottles and aluminum foil, their consumption is gradually decreasing.

"Medicinal Glass Bottles" is one of the medicinal glass product standards with the longest standard age, and it is now far from being able to adapt to market demand and the current state of products. Therefore, the National Medical Products Administration has included this product standard in a plan for restriction and revision. In order to meet the development of the pharmaceutical industry and the demand for biomedical and biological preparation drugs, the 2000 version of the pharmaceutical industry standards not yet officially published will refer to relevant standards.

Testing of Medicinal Glass

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

Physicochemical properties are important quality indicators and testing items of medicinal glass; they are the reflection and embodiment of the intrinsic quality of a product and directly affect the quality of drugs. The 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 refers to the chemical stability of medicinal glass. Since medicinal glass is a packaging container that directly contacts drugs, during the shelf life of a drug it must not cause the drug to deteriorate or become ineffective due to changes in chemical properties; therefore, the quality of chemical stability is directly related to the quality of the drug.

The testing of water resistance is divided into the grain method and the container method, and its 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 is a test of the chemical properties of the glass material, and the test method standards are GB12416.2-1990 "Glass - Hydrolytic resistance of glass grains at 121°C - Method of test and classification" and GB/T6582 "Glass - Hydrolytic resistance of glass grains at 98°C - Method of test and classification". The container method is a test of the chemical properties of the inner surface of glass, and the test method standards are GB12416.1-1990 "Medicinal glass containers - Hydrolytic resistance - Method of test and classification" and GB/T4548-1995 "Glass containers - Hydrolytic resistance of the interior surfaces - Method of test and classification".

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

Internal stress: internal stress refers to the annealing quality or annealing characteristics of glass. Glass containers with poor annealing quality are prone to breakage or shattering during use, affecting drug containment and medication safety. The commonly used standard for testing internal stress is GB12415-1990 "Inspection method for internal stress in medicinal glass containers". Its test principle is to determine the internal stress in glass containers by the optical path difference of different wavelengths. At present, the commonly used instrument is the LRR-8 digital display quantitative stress meter.

Internal pressure resistance: internal pressure is an item that measures 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 methods for internal pressure resistance of glass bottles and jars", and commonly used testing instruments include: TYJ-B linear pressurization internal pressure testing machine.

Thermal shock resistance: thermal shock resistance is the ability of a glass container to resist temperature changes, generally expressed by the temperature difference it 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 display automatic temperature-controlled thermal shock tester.

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

Breaking force: breaking force is an item for testing the snap-off performance of ampoules and is also an important indicator for measuring the performance of ampoules. The commonly used testing instrument is: ZLY-2000 digital display breaking force meter.

Acid and alkali resistance: acid and alkali resistance is an item that measures the chemical stability of glass. The test methods are GB6582-1986 "Glass - Determination of hydrochloric acid resistance at 100°C by flame emission or atomic absorption spectrometry", GB/T15728-1995 "Glass - Resistance to attack by boiling hydrochloric acid - Gravimetric method of test and classification", and GB/T6580-1997 "Glass - Test method and classification for resistance 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 medicinal glass. Consistent and stable specifications and dimensions are the basis of drug packaging production and have a great impact on drug filling, sealing, storage and use.

Geometric dimensions: the geometric dimensions of each part of the bottle mouth and bottle body are generally measured with digital electronic calipers, vernier calipers or height gauges.

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

Vertical axis deviation: a testing 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: ZPY-10 digital display axis deviation measuring instrument.

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

Weight and capacity: weight and capacity testing uses the weighing method and the 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. The testing of appearance quality items generally adopts visual inspection or measurement with a graduated magnifying glass.

Chemical composition and content of harmful substances

The testing of chemical composition and content of harmful substances is an important testing item for improving the quality level of medicinal glass containers and aligning with international levels.

The forthcoming pharmaceutical industry standard "Classification of medicinal glass compositions and their test methods" is a non-equivalent adoption of ISO12775-1997 "Glass - Classification by composition and their test methods for normal large-scale production". This standard clearly classifies and specifies the composition, material requirements, performance and application scope of various types of medicinal glass.

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

Online automatic inspection of medicinal glass containers

Online automatic inspection is the configuration of automatic inspection devices at the cold end of glass, performing full inspection of bottle dimensions and appearance defects according to set standards, and rejecting defective non-conforming products.

This inspection method is already widespread internationally, but domestic products of the same kind are basically inspected manually by eye, which is labor-intensive and has a high missed-detection rate. This is also one of the factors leading to the poor and unstable quality level of domestic medicinal glass container products. Accelerating the introduction, digestion, absorption, installation and use of online automatic inspection equipment will become the development direction and an effective way for medicinal glass containers to align with international levels and improve product quality.

——This article is reprinted from China Packaging Network (pack.cn). Original link: http://news.pack.cn/show-361840.html