Abstract: The sealing performance of pharmaceutical packaging bags is an extremely important performance index, which has an important impact on the quality of the packaged drugs. This paper specifically introduces the sealing performance of the sealing tester to detect the blister packaging, and enumerates the testing principle of the equipment, and describes the basic process of the test, which provides a reference for the enterprise to monitor the sealing performance of the pharmaceutical packaging bag.
Keywords: soft plastic packaging, bag packaging, medicine, sealing performance , sealing tester
1. The quality and safety of the drug directly affects the national health. As an important part of the drug, packaging plays an important role in the quality protection of the product after leaving the factory. In order to ensure the safety of medication, China has successively promulgated relevant regulations to list the quality inspection of pharmaceutical packaging and packaging materials as one of the key tasks that pharmaceutical companies must carry out; the pharmaceutical industry should not only pay attention to drug safety, but the safety of pharmaceutical packaging is equally important. The State Food and Drug Administration issued the "Compilation of Standards for Packaging Materials and Containers for Direct Contact with Drugs" from 2002 to 2006. The quality standards and testing methods for pharmaceutical packaging materials were unified and standardized, and passed on June 18, 2004. It also promulgated the "Administrative Measures for Packaging Materials and Containers Directly in Contact with Medicines", which clarified the types of pharmaceutical packaging materials that were registered and managed, and conducted spot checks on the production and circulation of pharmaceutical packaging materials.
2. Standards At present, the sealing performance test mainly refers to GB/T 15171-1994 "Test method for sealing performance of flexible packaging parts", which is applicable to the sealing performance test of sealed flexible packaging parts made of various materials.
3, test samples and instruments a brand of granule bag packaging, automatic sealing tester
4, test equipment
4.1 Test principle The equipment is developed using the differential pressure test principle. During the test, the sample is placed in the water of the sealed tank. By vacuuming the inside of the sealed tank, a pressure difference is generated inside and outside the sample immersed in the water. If the sample is poorly sealed, the gas inside the sample will be under the pressure difference. It leaks to the outside along the weak surface of the sample surface. In the water, there is continuous bubble generation on the surface of the sample, or the sealing performance of the sample is judged by observing the expansion of the sample and the recovery of the shape after releasing the vacuum.
4.2 Scope This equipment is suitable for the sealing performance test of packaging bags, bottles, tubes, cans, boxes, etc. in food, pharmaceutical, medical equipment, daily chemical, automotive, electronic components, stationery and other industries, including glass and plastic. Metal materials, etc. It is suitable for testing the sealing performance of samples after drop, pressure and other tests.
This equipment complies with a number of national and international standards, such as GB/T 15171, ASTM D3078 and so on.
4.3 Equipment parameters The vacuum is 0 ~ -90 KPa.
The effective size of the vacuum chamber is available in three options: 270 mm (diameter) × 210 mm (height), 360 mm (diameter) × 585 mm (height), 460 mm (diameter) × 330 mm (height).
The system uses digital preset test vacuum and vacuum hold time to ensure the accuracy of test data.
The automatic constant pressure air supply technology further ensures that the test can be carried out under preset vacuum conditions.
Professional software supports automatic backflush unloading and automatic end-of-test functions to ensure a smooth test process.
5, the test steps
(1) Dip the bag packaging sample in the water in the sealed can.
(2) Close the sealing cover to ensure that there is no air leakage around the sealing cover and the sealed can is sealed well. The test parameters such as the vacuum degree required for the test and the dwell time in the vacuum tank are set by the microcomputer operation interface.
(3) Turn on the vacuum pump and click the test button on the operation panel to start the test.
(4) Observe the bubble on the surface of the sample during vacuuming and holding. If there are continuous bubbles on the surface of the sample, the pressure value at which the continuous bubble appears and the position at which the bubble is generated are recorded. If no continuous bubble is generated, it indicates that the sample has good sealing under the set pressure.
6. Test results Sealing performance is an important performance of bag packaging. Sealing tester is a testing equipment specially used to test the sealing performance of blister packaging. It can not only quantitatively analyze the sealing performance of packaging, but also leak through the air. Qualitative analysis of the location can also provide a basis for improvements in the packaging process.
Diagnostic reagents can be divided into two categories: in vivo diagnostic reagents and in vitro diagnostic reagents. It is mostly a reagent for detection by the reaction between antigen and antibody.
A: Classification of in vitro diagnostic reagents:
1. In vitro biodiagnostic reagents managed as drugs include:
1. Blood type and tissue type reagents;
2. Microbial antigen, antibody and nucleic acid detection reagents;
3. Tumor marker reagents;
4. Immunohistochemistry and human tissue cell reagents;
5. Human genetic testing reagents;
6. Biochips;
7. Allergy diagnostic reagents.
2. In vitro reagents managed as medical devices include:
1. Clinical basic test reagents;
2. Clinical chemistry reagents;
3. Blood gas and electrolyte determination reagents;
4. Vitamin determination reagents;
5. Cell histochemical stains;
6. Autoimmune diagnostic reagents;
7. Microbiological test reagents.
B: According to medical test items, clinical diagnostic reagents can be roughly divided into clinical chemical test reagents, immunology and
Serological testing reagents, hematological and cytogenetic testing reagents, microbiological testing reagents, body fluid excretion
Detection reagents, genetic diagnosis reagents, etc. Among them, the market share of clinical chemistry
The largest, close to 34%; followed by the immunology market, accounting for about 29%. Novel immunodiagnostic reagents and genetic diagnostic tests
The reagent was developed in the late 1980s, and it is the most common diagnostic reagent for all current diagnostic reagents, regardless of technology or market.
The fastest growing product.
Urine Rapid Test Kit,Rapid Test Kit 6-Panel,Toxoplasma rapid test kits,Fecal Occult Blood Test
Jilin Sinoscience Technology Co. LTD , https://www.contoryinstruments.com