Pharmaceutical packaging testing instrument

AbstractThe pharmaceutical packaging testing instrument is recommended based on the testing requirements and methods specified in the national drug packaging material YBB00152002-2015 Pharmaceutical Aluminum Foil.

Keywords: YBB00152002-2015 Pharmaceutical Aluminum Foil, Pharmaceutical Aluminum Foil Testing Instrument, Drug Packaging Material Testing Instrument, Guangzhou Standard

Guangzhou Biaoji has been focusing on the development of pharmaceutical packaging material testing instruments for 15 years,

National standard material development unit for gas, oxygen, and water vapor permeability

Guangzhou Standardization Testing Center, certified by CNAS National Laboratory

More than half of domestic drug testing institutes, pharmaceutical factories, and drug packaging material factories use Guangzhou Biaoji to provide drug packaging material testing solutions.

1、 Test item: Needle hole degree

Aluminum foil is commonly used for drug packaging, such as blister packaging, aluminum-plastic composite film, bags, aluminum-plastic gaskets, aluminum-plastic ointment tubes, etc.

Aluminum foil has a highly dense metal crystal structure, theoretically capable of blocking any gas, water vapor, and light. However, in fact, due to the use of rolling technology in aluminum foil production, various factors such as the quality of rolling oil, the condition of rolling roll surface, process operation technology, and production site environment inevitably affect the appearance of various defects in aluminum foil, especially thin aluminum foil, among which pinholes are the most important.

The size and quantity of pinholes in aluminum foil have a decisive impact on the moisture resistance, gas barrier, and light shielding properties of aluminum foil and its composite materials

Recommended instruments:

GB-ZK pinhole tester

2、 Test item: Adhesive layer heat sealing strength

Take two pieces of this product measuring 100mm × 100mm, and another two pieces of solid medicinal hard PVC tablets measuring 100mm × 100mm (compliant with YBB00212005-2015) or solid medicinal composite hard PVC/polyvinylidene chloride tablets (compliant with YBB00222005-2015). Fold the adhesive layer of the sample onto the PVC surface (or the PVDC surface of the PVC/PVDC composite hard sheet). Place it in a heat sealer for heat sealing. The heat sealing conditions are: temperature 155 ℃± 5 ℃, pressure 0.2Mpa, time 1 second. After heat sealing, remove and cool it, cut it into 15mm wide samples, take the middle 3 samples, and measure them according to the heat sealing strength measurement method (YBB00122003-2015) at a test speed of 200mm/min ± 200mm/min. Clamp the PVC (or PVDC) sheet on the upper clamp of the testing machine and the aluminum foil on the lower clamp of the testing machine. Start the tensile testing machine for 180 ° angle peeling, and the average heat sealing strength shall not be less than 7.0N/15mm (PVC); Not less than 6.0N/15mm (PVDC)

Recommended instruments:

GBH-1 Intelligent Electronic Tensile Machine

GBB-H electronic heat sealer

3、 Test item: Heat resistance of protective layer

Take 3 pieces of this product with a thickness of 100mm/100mm, stack the protective layer of the sample with the aluminum foil raw material, place them on a heat sealer, and perform heat sealing. The heat sealing conditions are: temperature of 200 ℃, pressure of 0.2Mpa, and time of 1 second. Take them out and let them cool to room temperature. Separate the sample from the aluminum foil raw material and observe the heat resistance of the protective layer. The protective surface should have no obvious adhesion.

Recommended instruments:

GBB-H electronic heat sealer

4、 Testing item: rupture strength

Take 3 pieces of this product measuring 40mm x 40mm and place them on a rupture strength tester for testing. The pressure should not be lower than 98kPa.

Recommended instruments:

GNP-1 burst resistance tester

Fifth, Testing Item: Barrier Performance (Water Vapor Transmittance)

Determination of Water Vapor Transmittance (YBB00092003-2015)

*Test condition B (cup method)

Or the second experimental condition B (electrolytic analysis method)

Or the fourth method test condition 2 determination (infrared detector method)

During the experiment, the heat seal should face the low humidity side and should not exceed 0.5g/(㎡· 24h).

Recommended instruments:

*Method: Cup style method

W303 water vapor permeability tester

W533 water vapor permeability tester

Second method: electrolytic analysis method

W203 water vapor permeability tester

Third method: Infrared detector method

W403 water vapor permeability tester

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