Pharmaceutical composite hard film detection method and test instrument

Medicinal composite hard sheets generally have several processes such as PVC/PE, PVC/PVDC, PVC/PE/PVDC, etc., which are widely used in blister packaging of solid medicines, and are packaging materials for direct contact with medicines. The production and processing of medicinal composite hard sheets is complicated, the technical requirements are strict, and the production environmental sanitation indicators are very high. Therefore, it is very important to strengthen the monitoring of product and production environmental health indicators. At present, the relevant standards for the quality inspection of medicinal composite hard sheets are YBB00182004 "Aluminum, polyethylene cold-formed solid medicinal composite hard film", YBB00202005 "polyvinyl chloride, polyethylene, polyvinylidene chloride solid pharmaceutical composite Hard film", YBB00212005 "polyvinyl chloride solid medicinal hard film", YBB00222005 "polyvinyl chloride, polyvinylidene chloride solid pharmaceutical composite hard film", YBB00232005 "polyvinyl chloride, low density polyethylene solid medicinal composite hard Film, YBB00242002 "polyamide aluminum polyvinyl chloride cold stamping forming solid medicinal composite hard film" and so on.

First, the medicinal composite hard film barrier performance test
1. Test purpose:
Barrier performance is an important performance index for examining medicinal composite hard tablets. It plays a key role in the control of rancidity, anti-tarnishing, anti-hardening and oil-water separation.
2. Test method: The water vapor permeation amount is determined according to the method of YBB00092003* method-cup method (gravimetric test), the test temperature (38±0.6°C), the test relative humidity (90±2)%, the water vapor transmission amount shall not be greater than 15g/m2.24h. Oxygen permeation amount is tested according to the YBB00082003 standard method (pressure difference method for measuring oxygen permeation). The test temperature is 38±2°C (the oxygen permeation amount shall not exceed 4000cm3/m2.24h.0.1Mpa.
3, test equipment: water vapor transmission test using Labthink blue light W3 / 030 moisture permeability tester, oxygen transmission test using VAC series differential pressure gas permeation instrument can be tested.
Second, the mechanical properties of the medicinal composite hard sheet (tensile strength, elongation at break) test
1. Test purpose: The
medicinal composite hard sheet should bear the weight of the contents during use, and also subject to some external force. Therefore, the mechanical properties should be measured and the mechanical properties should be qualified by testing.
2. Test method: The tensile strength method refers to the tensile property measurement method (YBB00112003). The index is determined according to the experimental verification results. Generally, the average tensile strength in the longitudinal and transverse directions is not less than 10 MPa, and the elongation at break method refers to the tensile properties. Determination method (YBB00112003), the index is based on the experimental verification results, the thickness of the film is less than 0.05mm, the average elongation requirement is not less than 130%; the film larger than 0.05mm, the average elongation at break is not to be low. At 200%.
3. Test equipment: Labthink Languang XLW series intelligent electronic tensile testing machine can be used for inspection. Samples are prepared according to the standard regulations, and then clamped on the upper and lower fixtures of the intelligent electronic tensile testing machine to set the test speed (recommended) Start the test and test the test results by selecting the speed of 500mm/min.
Third, the medicinal composite hard film heat shrinkage strength test
1. Test purpose:
for the detection of heat seal strength of heat seal parts
2. Test method: The test is carried out according to the YBB00122003 (heating strength measurement method) standard. Cut 4 pieces of 100mm × 100mm diaphragm, PVC hard sheet or PVC/PVDC composite hard sheet for heat sealing (bonding the adhesive layer of aluminum foil to PVC sheet), put it on the heat sealer for hot pressing and sealing, then use The standard cutter cuts the sample into a width of 15 mm, and takes the middle three strips by 180° peeling (the stripping speed is performed according to the requirements of the specific testing standards), and the necessary work for peeling is the heat sealing strength.
3. Test equipment: The HST-H3 type heat seal tester of Labthink can be used to prepare the heat seal sample, and then the XLW series intelligent electronic tensile test machine can be used to test the heat seal strength.
Fourth, the medicinal composite hard film impact resistance test
1. Test purpose: It is
used to test the falling ball impact resistance of the hard piece.
2. Test method: It can be carried out according to the YBB00222005 standard. Cut 150mm × 50mm, 5 pieces in each of the vertical and horizontal directions. The sample shall be placed in an environment of a temperature of 23 ° C ± 2 ° C and a relative humidity of 50% ± 5 ° C for more than 4 hours and tested under the above conditions. Fix the sample (PVDC face up) on the clamp of the ball drop impact tester, span 100mm, select the steel ball and the ball height according to the requirements of Table 2 of the standard, so that the steel ball can fall freely at the center of the span, both vertically and horizontally. There must be no more than two pieces of damage.

The above information is provided by Jinan Languang Electromechanical Technology Co., Ltd. Specialized finishing, in order to help the quality control of medicinal composite hard film manufacturing and use enterprises, and our company also has a professional laboratory to carry out the testing of all the above projects, hoping to communicate with industry colleagues on more issues.

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