Quality requirements and testing methods for butyl rubber stoppers in drug packaging standards

1. Reference Standards (partial):

YBB00042005-2015 injection

YBB00052005-2015 injection

YBB00322004-2015 injection

YBB00332004-2015 Rubber Plug Gasket for Injection-Determination of Puncture Chip

1. Puncture chip

Take 10 samples, and measure them according to YBB00332004-2015, the rubber stopper and gasket puncture chip drop test method for injections, and the chip drop should not exceed 20 tablets.

Test method:

Choose 20 injection bottles, add 1/2 nominal volume of water in each bottle. Take 10 rubber stoppers to be tested and 10 known puncture chipping rubber stoppers, install them on injection bottles, cover with aluminum caps or aluminum-plastic composite caps, and perform pretreatment after sealing. After the pretreatment is completed, wipe the metal piercer with acetone or other appropriate organic solvents, then hold the piercer, vertically puncture the marked part on the rubber stopper to be tested, shake the injection bottle for a few seconds after piercing, and then pull out the piercer.

Filter all the water in the injection bottle through a piece of filter paper, and observe the number of debris on the filter paper with the naked eye at a distance of 20 cm from the filter paper. If necessary, the size and quantity of debris can be further confirmed through a microscope.

Attached metal piercer standard requirements

2. Puncture force

Take 10 samples. According to the second method of YBB00322004-2015 method for measuring the puncture force of rubber stoppers and gaskets for injections, the force required to puncture the stoppers shall not exceed 10N.

Test method:

The rubber stopper samples were pretreated according to the standard requirements.

Take 10 injection bottles with rubber stoppers, add water of nominal capacity respectively, install the pretreated rubber stoppers to be tested, add aluminum caps or aluminum-plastic composite caps, and seal them. Fix an injection needle on the material testing machine, put the injection bottle into the material testing machine, open the aluminum cover or the aluminum-plastic composite cover, leak out the marked part of the rubber stopper, puncture vertically at a speed of 200mm/min, and record the glue. Maximum force applied for plug puncture. Replace an injection needle and repeat the above steps until all rubber stoppers are punctured once.

Puncture device diagram

3. Tightness between rubber stopper and container

Take 10 samples and perform pretreatment according to the method specified in the drug packaging material standard. Put the pretreated experimental sample into a container with a pumping device containing 10% methylene blue solution, evacuate to a vacuum degree of 25kPa, and maintain it for 30 minutes. Rinse the outer wall of the bottle and observe that the methylene blue solution must not penetrate into the bottle.

Tester needed Cell Instruments vacuum leak tester LT-03

4. Sealing and punture needle retention

Take 10 samples, and carry out pretreatment according to the method required by the standard for pharmaceutical packaging materials. Use the piercer shown in Figure 1 in YBB00322004-2015 of the method for measuring the puncture force of rubber stoppers and gaskets for injections, and puncture the pretreated sample vertically toward the puncture site of the rubber stopper. A 0.5kg weight is suspended from the device, and the puncturer should not be pulled out for 4 hours, and there should be no leakage at the punctured part of the bottle stopper.

With puncture needle specifications

The above describes the quality control items and test methods for butyl rubber plugs in the packaging material standards, hoping to help you. Jinan Theo Electrical Co., Ltd. specializes in laboratory testing equipment research and development, manufacturing and sales. Theo continues to develop and improve manufacturing processes and design concepts. Products with excellent performance has won the extensive trust of customers and a wide range of services in packaging, food, medicine, plastics, paper products, daily chemical, quality inspection agencies, colleges and universities and other fields.

Jinan Theo Electromechanical Co., Ltd. has always been customer-centric, insisting on providing customers with cost-effective and stable products and services, and determined to provide users with quality control and research equipment.

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