Abstract: In order to ensure the effectiveness of pharmaceutical composite films and bags in drug packaging, Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd. has summarized some routine testing items and equipment used for pharmaceutical composite films and bags in accordance with the requirements of YBB00132020-2015 "General Principles for Pharmaceutical Composite Films and Bags" standard. This article will provide a brief analysis of the experimental project of YBB00132020-2015 "General Principles for Medicinal Composite Films and Bags".

Medicinal composite films and bags have a wide range of applications in the field of pharmaceutical packaging, with advantages such as low cost, stable performance, good barrier properties, and good sealing. Belonging to a composite packaging form, it is a packaging material that directly contacts drugs. Due to the special nature of drugs, the composite film used must not only meet the medicinal requirements, but also not contaminate the drugs due to its own reasons, increase the safety risks of drugs, and threaten human health.

In 2015, the State Food and Drug Administration issued the YBB00132020-2015 "General Principles for Medicinal Composite Films and Bags" standard, which sets strict requirements for the quality of composite film bags for traditional Chinese medicine. The testing items specified in the standard include heat sealing strength, thickness uniformity, inner and sub inner layer peel strength, sealing, film bag pressure resistance, bag drop resistance, heat sealing performance, etc.

1. YBB00132002 Pharmaceutical Composite Film and Bag Heat Sealing Strength Index Testing

Testing the heat sealing strength of medicinal composite films and bags can effectively prevent problems such as air leakage at the heat seal or root fracture of the heat seal due to poor or excessive heat sealing of the packaging material.

Experimental equipment: RFY-03 heat sealing instrument and DLS-07 intelligent electronic tensile testing machine from Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd

The standard requires the heat sealing strength of YBB00132002 pharmaceutical composite film and bag to be determined according to the heat sealing strength measurement method YBBOO122003-2015. The measured values should comply with the provisions of Table 3.

2. Testing of thickness uniformity index for YBB00132200 pharmaceutical composite film and bag

The uniformity of the thickness of medicinal composite films and bags is the basis for ensuring their good performance. Professional testing equipment is required to complete the experiment. The CHY-U standard for YBB00132002 pharmaceutical composite film and bag thickness uniformity index testing by Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd. requires a thickness deviation of ± 10% for the film and an average thickness deviation of ± 10%

3. Testing of peel strength indicators for YBB00132002 pharmaceutical composite film, bag inner layer and sub inner layer

The peel strength of the medicinal composite film, inner layer and sub inner layer of the bag reflects the production process of the packaging bag, which has a direct impact on the sealing of the packaging.

Experimental equipment: Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd. Intelligent Electronic Tensile Testing Machine DLS-07

Standard requirements for testing the peel strength indicators of YBB00132200 pharmaceutical composite film, bag inner layer and sub inner layer: Take an appropriate amount of film and bag, and measure according to the peel strength measurement method YBBOO102003-2015. The average values of longitudinal and transverse peel strength should comply with the provisions of Table 3

4. YBB00132002 Pharmaceutical Composite Film and Bag Sealing Index Testing

The sealing of medicinal composite films and bags is mainly a testing item for the packaging of finished drugs, which aims to identify the areas where packaging bags are prone to air leakage and prevent drugs from getting damp or oxidized.

Experimental equipment: Sealing tester from Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd

Method for testing the sealing index of medicinal composite film bags: Place the sample in a container with an exhaust device, immerse it in water, vacuum it to a vacuum degree, and maintain it for a period of time. There should be no water ingress or bubbling inside the bottle.

5. YBB00132002 Pharmaceutical Composite Film and Bag Pressure Resistance Index Testing

To verify the pressure resistance performance of pharmaceutical composite films and bags, and prevent packaging bags from breaking or leaking due to stacking or external compression.

Experimental equipment: Packaging bag pressure tester from Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd

Requirements for testing the pressure resistance index of YBB00132200 pharmaceutical composite film and bag: Take 5 bags, fill them with about one tenth of the bag capacity of water, and heat seal them (refer to the heat sealing conditions used in the production process). Place the samples one by one between the upper and lower plates. During the test, the upper and lower plates should be kept horizontal without deformation, and the contact surface with the bag must be smooth. The area of the upper and lower plates should be larger than that of the test bag. According to Table 4, the magnetic code should be kept for 1 minute (with a load equal to the sum of the weight of the upper pressing plate and the brick code), and visually inspected without cracking or leaking.

6. YBB00132002 pharmaceutical composite film and bag anti drop index testing

Verify by conducting anti drop tests on packaging bags to prevent the finished packaging of drugs from breaking during drops.

Experimental equipment: Packaging drop testing machine from Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd

Standard YBB00132002 pharmaceutical composite film and bag anti drop index testing: Take 5 bags, fill them with about half of the bag capacity of water, and heat seal them (refer to the heat sealing conditions used in the production process). Place the samples one by one according to the height in Table 5 on a smooth and hard horizontal surface (such as a cement floor). Visually, there should be no rupture.

In addition, YBB00132020-2015 "General Rules for Medicinal Composite Films and Bags" standard does not specify it, but the internal quality control standards of pharmaceutical factories stipulate that the equipment required for testing physical indicators such as medicinal composite films, bag sealing, solvent residue, heat sealing, smoothness, and rub resistance are all sold.

Jinan Sanquan Zhongshi Experimental Instrument Co., Ltd. is a professional manufacturer of testing instruments. Our mission is to provide data, easy operation, and guaranteed after-sales service for pharmaceutical packaging material factories, pharmaceutical factories, glass factories, drug testing centers, and third-party testing units.