Standard and inspection of glass packaging contain

Standards and testing of pharmaceutical glass packaging containers

standards of pharmaceutical glass

China has 24 pharmaceutical glass standards, 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, there is a widespread problem of long standards, most of which were formulated in the 1980s or 1990s, seriously lagging behind the development of the industry and products. The degree of adopting international standards is poor, and most standards are {todayhot} problems such as non equivalent adoption. After joining the WTO, the pharmaceutical glass industry and products should be in line with international standards, and the standards must be reformed first

take pharmaceutical glass product standards as an example, there are 9 existing standards. With the development of the market, the structure and use of medicinal glass bottles have undergone fundamental changes. The consumption of some varieties is less and less, and the relevant standards are no longer appropriate. For example, most of the large-size bottles and wide mouth bottles used to contain tablets are replaced by plastic bottles, aluminum foil and other materials. At present, oral liquid preparations mainly used to contain all kinds of health drugs and nutritional drugs are in the majority in the market, and are developing in the direction of high-grade and small standardization. Screw mouth controlled glass bottles are mainly used to contain tablets, powders and other oral drugs. With the replacement of plastic bottles, aluminum foil and other new materials, the dosage is gradually decreasing. "Medicinal glass bottle" is the longest bid winning standard for medicinal glass products. Now it is far from meeting the market demand and product status. Therefore, the State Drug Administration has included the product standard in the restriction and revision plan. In order to meet {hottag} the development of the pharmaceutical industry and the needs of biomedical and biological agents, plastic manufacturers know that plastic is mainly composed of resin and will refer to relevant international standards for the 2000 edition of pharmaceutical industry standards that have not been officially published

inspection of medicinal glass

the inspection items of medicinal glass are mainly divided into physical and chemical properties, specifications and dimensions and appearance quality according to their product uses. After being in line with the international standards and testing methods of pharmaceutical glass, the detection of chemical composition and leaching content of harmful substances of glass should be increased

physical and chemical properties

physical and chemical properties are important quality indicators and testing items of medicinal glass, which reflect and reflect the internal quality of products and directly affect the quality of drugs. The physical and chemical performance testing items include: water resistance, internal stress, internal pressure resistance, thermal shock resistance, freezing resistance, breaking force, acid resistance and resistance

water resistance: water resistance refers to the chemical stability of medicinal glass. Because medicinal glass is a packaging container that directly contacts drugs, it cannot cause deterioration or failure of drugs due to changes in chemical properties within the shelf life of drugs. Therefore, the quality of drugs is directly related to the quality of drugs

the detection of water resistance is divided into particle method and 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 particle method is to test the chemical properties of glass materials, and the test method standard is gb12416 Test and classification of water resistance of glass particles at 121 ℃, gb/t6582 particle test and classification of water resistance of glass at 98 ℃. The container method is to test the chemical properties of the inner surface of glass, and the test method standard is gb12416 "Test method and classification of water resistance of medical glass containers", gb/t "test method and classification of water erosion resistance of inner surface of glass containers"

in addition, in order to be in line with international standards, the draft national standard "the method of zigzag test pieces for water erosion resistance of glass products and glass containers is often used to determine the strength and differential performance of brittle and low plastic materials such as cast iron, casting alloy, tool steel and cemented carbide, and to determine and grade by flame spectrometry". This standard can be used for quantitative determination of water resistant substances released from the surface of glass 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 easy to break or burst in the process of use, which affects the storage of drugs and the safety of medication. The commonly used standard for detecting internal stress is GB "internal stress inspection method for pharmaceutical glass containers". Its test principle is to determine the internal stress in glass containers based on the optical path difference of different wavelengths. At present, the commonly used is lrr-85a digital display quantitative stress tester

internal pressure resistance: internal pressure is an item to measure the comprehensive strength of glass containers. The internal structure of glass, the non-uniformity of glass wall thickness and surface appearance defects will affect the strength of glass. The testing method standard is gb/t "test method for internal pressure resistance of glass bottles and cans". The commonly used testing instruments are: tyj-b linear pressurized internal pressure testing machine

thermal shock resistance: thermal shock resistance is the ability to test the resistance of glass containers to temperature changes, which is generally expressed by heat-resistant temperature difference. The test method standard is GB test method for thermal shock resistance and thermal shock durability of glass containers. The commonly used detection instrument is the digital display automatic temperature change instrument

freezing resistance: freezing resistance is a test item to measure the low-temperature performance of glass. It is mainly used for the inspection of freeze-drying agent glass bottles. The test instrument is freezers below -43 ℃

breaking force: breaking force is an item to test the safety and easy breaking performance, and it is also an important index to measure the safety and service performance. The commonly used testing instrument is: zly-2000 digital display refractometer

acid resistance: acid resistance is an item to measure the chemical stability of glass. The detection methods are GB "flame emission or atomic absorption spectrometry method for resistance of glass to hydrochloric acid attack at 100 ℃", gb/t "gravimetric test method and classification for resistance of glass to boiling hydrochloric acid attack", and gb/t "test method and classification for resistance of glass to mixed aqueous solution". The main detection instruments are flame photometer, atomic absorption spectrometer and conventional laboratory instruments

specifications and sizes

specifications and sizes are the main molding process quality of medicinal glass. Consistency and good and stable specifications and sizes are the basis of drug packaging production, which have a great impact on the filling, sealing, storage and use of drugs

geometric dimensions: the geometric dimensions of the bottle mouth and bottle body are generally measured with digital electronic caliper, vernier caliper or height gauge

thickness of bottle wall, bottom and mouth: commonly used measuring instruments include: digital display electronic bottle bottom thickness, wall thickness measuring instrument, digital display electronic bottle mouth edge thickness measuring instrument

vertical axis deviation: inspection items of bottle verticality. The test method standard is GB "glass container - glass bottle vertical axis deviation test method", and the measuring instrument is zpy-10 digital display axis deviation measuring instrument

straightness: straightness is a test item for the bending degree of glass tubes. The commonly used measuring instrument is lsr-1000 digital display glass tube straight sensor linearity instrument

weight and capacity: weight and capacity detection is to measure the weight and volume of bottles by weighing method and titration method

appearance quality

appearance quality is an item for detecting various surface defects of glass containers, mainly including stones, bubbles, stripes, bubble lines, cracks, seam lines, etc. the inspection of appearance quality items is generally measured by visual inspection or a magnifying glass with scale

chemical composition and content of harmful substances

the detection of chemical composition and content of harmful substances is an important test item to improve the quality level of pharmaceutical glass containers and meet the international level

the upcoming pharmaceutical industry standard "classification and test methods of pharmaceutical glass components" adopts ISO "classification and test methods of normal mass-produced glass by components". This standard has made clear classification and provisions on the composition, material requirements, performance and application scope of all kinds of pharmaceutical glass

raw materials for pharmaceutical glass production often use As2O3 and Sb2O3 as clarifiers to introduce glass components. International standards stipulate the release amount of these substances. China is currently formulating relevant control and detection standards to limit harmful elements from the perspective of safety and health

automatic detection of pharmaceutical glass containers

automatic detection is to configure an automatic detection device at the cold end of the glass, carry out all-round detection of the size and appearance defects of the bottle according to the set standards, and eliminate the defective unqualified products

this detection method has been widely used in the world, but domestic similar products are basically manual visual inspection, with high labor intensity and high omission rate. It is also a factor that leads to the poor and unstable quality level of medicinal glass containers with an average annual growth rate of about 10 percentage points lower than that of "1015". Accelerating the introduction, digestion, absorption, installation and use of automatic detection equipment will become the development direction and effective way for pharmaceutical glass containers to be in line with international standards and improve product quality