Necessity of leak detection of injection -- principle of nondestructive application

The discussion on the necessity of leak detection of injection on the Internet is also the view of netizens (excerpted from dingxiangyuan pharmaceutical Forum) 1 Because in the production process, there will inevitably be a variety of defective products, especially some very small cracks (sometimes when the ampoule wall is in contact with the gear carrier during filling, there will be collisions or cold parts immediately after sealing, which are all encountered in the production process), which cannot be seen by the naked eye Therefore, from the perspective of quality assurance, leakage detection should be carried out after sterilization! Netizen's point of view 2: the leak detection technology of the container after injection sterilization is very important If there is a leak in the container, all efforts before the leak is found are close to zero If the leaked product is not found and removed before packaging, the result is likely to be that the product with virus or microorganism enters the market for patients, and because some injections are used for intravenous injection, because of this, the leak detection process has been paid more and more attention by the pharmaceutical industry For more opinions, please click (http://pharmaceutics.dxy.cn/bbs/topic/5995955) [the necessity of injection leak detection] the Chinese Pharmacopoeia has the following provisions: after fusion sealing or strict sealing, generally, appropriate methods should be selected for sterilization according to the nature of the drug, and the sterilization of the finished product must be guaranteed When the injection is sterilized or after sterilization, the pressure reduction method or other appropriate methods shall be used to detect the leakage of the container (excerpted from Appendix 7 of 2010 edition of Chinese Pharmacopoeia) Many medical accidents are often caused not by the adverse reactions of patients and drugs, but by the bacterial changes of drugs caused by the neglected vessel leak detection link, the necessity of conforming to the demand, the reform of domestic policies, and the entry of international advanced leak detection equipment We need to explore and think about the cost, technology, accident risk and other aspects Once the necessity of injection leak detection is confirmed, the follow-up work should be carried out in succession [know and choose the leak detection method that conforms to our own] there are several leak detection methods as follows: · laser leak detection method (recommended by FDA in the United States, with a brief introduction to laser leak detection method below) · vacuum leak detection method for partial or integral containers (recommended by FDA in the United States) · discharge micropore leak detection method · color water leak detection method Excerpted from: Discussion on leak detection method of injection inner packaging container, Yang Chunwen, * Sankong pharmaceutical click for detailed method description (http://www.docin. COM / p-425412335 HTML) how to define the leak detection method in line with their own? Judging factors (http://jingyan.baidu.com/article/908022c678d7fd90c80f7a HTML) [advanced laser non-destructive leak detection technology] lighthouse, a global leading laser testing expert, uses laser diode spectroscopy principle equipment non-destructive leak detection and non-destructive headspace gas analysis, mainly including headspace oxygen, water & pressure, carbon dioxide test As the detection method recommended by USP, laser detection technology is widely used, especially in the pharmaceutical field, such as non-destructive residual oxygen analysis, non-destructive vacuum test, container sealing integrity test, product stability research, shelf life research, permeability research, etc It can be used to analyze the non-destructive residual oxygen, vacuum degree, carbon dioxide and moisture (water pressure) of various products in pharmaceutical industry Generally, the above parameters can be used to determine whether there is leakage in the packaging Lighthouse technology has been funded, affirmed and recommended by FDA Now, nearly 400 lighthouse laser testing systems have been used in the world Reprint please indicate the source: Shanghai Zhonglin mechanical and Electrical Equipment Co., Ltd may have many questions about leak detection You can consult Shanghai Zhonglin to answer your professional questions Product marketing is only part of it Sharing scheme is a common learning goal