The Ampoule Testing Project The State Food and Drug Administration has clearly stated in the 2002 edition of the “Compilation of Packaging Materials and Containers for Direct Contact with Drugsâ€, but after 10 years, some ampoule quality does not meet the requirements. .
Medicinal packaging container ampoules bottle quality control and research analysis program
An ampoule is a sealed vial that is commonly used to store injectable drugs as well as vaccines, serums, etc. It is a fusible sealed hard glass container for injectable or water for injection and is now widely used in the pharmaceutical industry. Because ampoules are packaging containers that come into direct contact with pharmaceuticals, the quality of ampoules has become a topic of concern for production and users.
On November 14, 2013, representatives of our company participated in the China Pharmaceutical and Packaging Seminar. Mr. Sun Huimin, Director of the Packaging Materials and Pharmaceutical Excipients Certification Institute of China National Food and Drug Testing Institute, conducted a quality control on the quality of the ampoule and the problems encountered. A detailed explanation. According to the response of the director of the market in recent years, the unqualified rate of the low borosilicate glass ampoule breaking force is 18.6%, and the disqualification rate of the neutral borosilicate glass ampoule breaking force is 7.7% (Note: more than 90% of China's Ampoules are low borosilicate glass ampoules). The Ampoule Testing Project The State Food and Drug Administration has clearly stated in the 2002 edition of the “Compilation of Packaging Materials and Containers for Direct Contact with Drugsâ€, but after 10 years, some ampoule quality does not meet the requirements. . Main reasons: 1. The backwardness of the production process, 2. To save costs and reduce quality control requirements. 3. I am not aware of the impact of ampoule quality, especially breaking force, on drugs. In fact, the breaking force of the ampoule is related to the quality of the drug and the safety of the medical staff.
Before opening the ampoule, use a grinding wheel to cut the scratch at the bottle neck, disinfect the bottleneck, and raise the nipple so that the liquid all flows into the bottle, and then the bottleneck can be broken. The easy-folding ampoule indicates the pre-cut part of the manufacturer at the nipple, and the nipple can be directly broken in this direction. If the breaking force of the ampoule is too large or too small, the fracture site may be uneven, causing some small glass debris to fall into the drug, which may not only contaminate the drug, but may cause harm to the patient. On the other hand, the medical staff is breaking the ampoule. It may affect the safety of medical personnel because of spattering. The existing national standards indicate that the plane of the qualified ampule breakage should be flat and free of cracks. Many unqualified ampoules on the market will have gaps, large numbers of cracks and spikes. The State Food and Drug Administration has now revised the requirements for the broken plane of the ampoule in the standard: after the ampoule is broken, the section should be flat (no cracks exceeding the shoulder, and no height or height of more than 2 mm). At present, there are special instruments on the market to detect the breaking force of the ampoule. For example, the Zirconium Breaking Force Tester ZDY-01 produced by Sanquan Zhongshi is fully compliant with national standards and can be used for the breaking force of 1-20ml ampoules. The value is measured, and the computer software contained in the device can be connected to the computer to more intuitively view the test process, data curve, print out the experimental report of A4 paper, and facilitate the user to store the query information.
By participating in this seminar, we deeply realized the impact of the quality of ampoule on drugs, patients and medical personnel. It can be seen that controlling the value of the breaking force of an ampoule is an important test item. Here we also hope that the relevant production enterprises and the use of departments to strengthen the quality control of the ampoule breaking force.
For details, please call: Chen Meiru 0531-6781 3036 156 6677 5359
Http://news.chinawj.com.cn Editor: (Hardware Business Network Information Center) http://news.chinawj.com.cn
Medicinal packaging container ampoules bottle quality control and research analysis program
An ampoule is a sealed vial that is commonly used to store injectable drugs as well as vaccines, serums, etc. It is a fusible sealed hard glass container for injectable or water for injection and is now widely used in the pharmaceutical industry. Because ampoules are packaging containers that come into direct contact with pharmaceuticals, the quality of ampoules has become a topic of concern for production and users.
On November 14, 2013, representatives of our company participated in the China Pharmaceutical and Packaging Seminar. Mr. Sun Huimin, Director of the Packaging Materials and Pharmaceutical Excipients Certification Institute of China National Food and Drug Testing Institute, conducted a quality control on the quality of the ampoule and the problems encountered. A detailed explanation. According to the response of the director of the market in recent years, the unqualified rate of the low borosilicate glass ampoule breaking force is 18.6%, and the disqualification rate of the neutral borosilicate glass ampoule breaking force is 7.7% (Note: more than 90% of China's Ampoules are low borosilicate glass ampoules). The Ampoule Testing Project The State Food and Drug Administration has clearly stated in the 2002 edition of the “Compilation of Packaging Materials and Containers for Direct Contact with Drugsâ€, but after 10 years, some ampoule quality does not meet the requirements. . Main reasons: 1. The backwardness of the production process, 2. To save costs and reduce quality control requirements. 3. I am not aware of the impact of ampoule quality, especially breaking force, on drugs. In fact, the breaking force of the ampoule is related to the quality of the drug and the safety of the medical staff.
Before opening the ampoule, use a grinding wheel to cut the scratch at the bottle neck, disinfect the bottleneck, and raise the nipple so that the liquid all flows into the bottle, and then the bottleneck can be broken. The easy-folding ampoule indicates the pre-cut part of the manufacturer at the nipple, and the nipple can be directly broken in this direction. If the breaking force of the ampoule is too large or too small, the fracture site may be uneven, causing some small glass debris to fall into the drug, which may not only contaminate the drug, but may cause harm to the patient. On the other hand, the medical staff is breaking the ampoule. It may affect the safety of medical personnel because of spattering. The existing national standards indicate that the plane of the qualified ampule breakage should be flat and free of cracks. Many unqualified ampoules on the market will have gaps, large numbers of cracks and spikes. The State Food and Drug Administration has now revised the requirements for the broken plane of the ampoule in the standard: after the ampoule is broken, the section should be flat (no cracks exceeding the shoulder, and no height or height of more than 2 mm). At present, there are special instruments on the market to detect the breaking force of the ampoule. For example, the Zirconium Breaking Force Tester ZDY-01 produced by Sanquan Zhongshi is fully compliant with national standards and can be used for the breaking force of 1-20ml ampoules. The value is measured, and the computer software contained in the device can be connected to the computer to more intuitively view the test process, data curve, print out the experimental report of A4 paper, and facilitate the user to store the query information.
By participating in this seminar, we deeply realized the impact of the quality of ampoule on drugs, patients and medical personnel. It can be seen that controlling the value of the breaking force of an ampoule is an important test item. Here we also hope that the relevant production enterprises and the use of departments to strengthen the quality control of the ampoule breaking force.
For details, please call: Chen Meiru 0531-6781 3036 156 6677 5359
Http://news.chinawj.com.cn Editor: (Hardware Business Network Information Center) http://news.chinawj.com.cn
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