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YBB 0008-2005 (YBB 0008-2003) PDF English

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YBB 0008-2003: Tests for Gas Transmission
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Status: Obsolete

YBB 0008: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YBB 0008-2005English279 Add to Cart 3 days Caps made of aluminium for Injection Obsolete
YBB 0008-2004English239 Add to Cart 2 days Bromobutyl rubber plungers for prefilled syringes Obsolete
YBB 0008-2003English90 Add to Cart 0-9 seconds. Auto-delivery Tests for Gas Transmission Obsolete
YBB 0008-2002English199 Add to Cart 2 days PP Bottles Oral Liquid Preparation Obsolete

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YBB 0008-2003: Tests for Gas Transmission

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YBB0008-2003
YBB National Drugs Packing Containers (Materials) Standards YBB00082003 Tests for Gas Transmission (on trial) China Food and Drug Administration China Food and Drug Administration National Drugs Packing Containers (Materials) Standards YBB00082003 Tests for Gas Transmission (on trial) Gas transmission quantity is, under constant temperature and unit pressure, the gas volume that transmits stably through per unit area of the sample in per unit time. It is expressed as the value of volume under standard temperature and pressure with the unit. cm3/ (m2·24h·0.1Mpa). Gas transmission coefficient is, under constant temperature and unit pressure difference, the gas volume that transmits stably through per unit thickness and unit area of the sample in per unit time. It is expressed as the value of volume under standard temperature and pressure with the unit. cm3·cm/ (m2·S·Pa). Testing environment. temperature. (23±2)°C, relative humidity. (50±5) %. First method. Pressure-difference method Use medicinal membrane or sheet to separate low pressure chamber from high pressure chamber. The volume of low pressure chamber is known; then inflate about 0.1Mpa test gas into high pressure chamber. After sealing, use the vacuum pump to evacuate the gas in low pressure chamber until approaching zero value. Use manometer to measure the rise of pressure in low pressure chamber. Thus, the gas volume transmits through sample from high pressure chamber to low pressure chamber based on time function will be determined. However, the initial phase of transmission velocity that changes over time shall be excluded. Apparatus The meters and equipment for testing gas transmission quantity are as bellows. Vent chamber. it is consisted of two parts. When sample is installed, the upper part is high pressure chamber used for storing test gas, and the lower part is low pressure chamber used for storing the transmitted gas and measuring the pressure difference during transmission. Both parts are equipped with injection pipes for test gas. valve of high-pressure chamber; start to evacuate the vacuum until the pressure is lower than 27Kpa; then keep degassing. After degassing, open test gas cylinder; turn on gas-source valve; inflate the test gas into high-pressure chamber. The gas flow per minute is 100ml. Gas pressure of high-pressure chamber shall be kept within (1.0~1.1) ×105Pa. Close the vent valves of high- pressure and low-pressure chambers; start the transmission test. In order to exclude the nonlinearity phase in the beginning, 10 minutes pre-transmission is required. When the changes of pressure difference over certain time intervals are gradually constant, stable transmission is accomplished. Gas transmission quantity (Qg) shall be calculated according to formula (1). Formula (1). Where. Qg — Gas transmission quantity, cm3/ (m2·24h·0.1Mpa); ΔP/Δt — Arithmetic mean value of pressure changes of low pressure chamber in unit time during stable transmission, Pa/h; V — Volume of low pressure chamber, cm3; S — Test area of sample, m2; T — Test temperature, K; P1-P2 — Pressure difference on sample’s both sides, Pa; T0, P0 — Temperature (273.15K) and pressure (1.0133×105Pa) under standard state. Test result is expressed as the arithmetic mean value of three samples. The difference between determined value of each sample and arithmetic mean value shall not be greater than ±10%. Gas transmission coefficient (Pg) shall be calculated according to formula (2). Formula (2). ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.