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| YBB 0008-2005 | English | 279 |
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Caps made of aluminium for Injection
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Bromobutyl rubber plungers for prefilled syringes
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Tests for Gas Transmission
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PP Bottles Oral Liquid Preparation
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YBB 0008-2003: PDF in English YBB00082003 (YBB 0008-2003)
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 PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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