Sterile drugs detect damaged or defective products in the final sealed product inspection process to prevent contamination of products due to seal integrity defects. The implementation of the new domestic GMP, the pharmaceutical industry production process quality standards are getting higher and higher Source: Shanghai Zhonglin Electromechanical Equipment Co., Ltd. Wood Grain Texture PU Sandwich Panel
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Sterile drugs detect damaged or defective products in the final sealed product inspection process to prevent contamination of products due to seal integrity defects. The implementation of the new domestic GMP, the pharmaceutical industry production process quality standards are getting higher and higher, the need for sterile drug leak detection in the pharmaceutical industry is increasing, the sterile drugs are mainly concentrated in the vials, infusion bottles, ampoules , leak detection and integrity leak detection such as blister packaging. At present, the commonly used sealing leak detection methods in the market include: vacuum attenuation method, water bath dyeing method, microbial intrusion method, high pressure discharge method and the like.
The water bath staining method is not sensitive enough, too objective, and the accuracy of controlling the leak is too low. This method has the risk of microbial contamination. The crack on the container needs to be large, so that it can be detected in the visual inspection, and the leakage of the dye solution which is small and not easy to detect may cause microbial or chemical pollution. The defect of microbial intrusion method is that the leak detection time is too long, too insensitive, and some microbial strains are also expensive, and the high pressure discharge method has certain limitations, only the conductive medium can be detected, but for the freeze-dried powder. Needles are not suitable, and high-voltage discharge in some manufacturers in France, the line speed is very low can not keep up with the production rhythm. The advantages of the high pressure discharge method are: high reproducibility. It can be used to identify the weak points of containers, which may be damaged during transportation, providing reference information for enterprises to strengthen quality management throughout the product life cycle. The vacuum attenuation method applies advanced modern detection methods to the detection of pharmaceutical packaging integrity, overcomes the limitations of high-voltage electricity detection on the drug itself, and ensures the stability of the product. The detection speed is faster, more stable, the level of automation control is higher, and the operation is more humanized. For the detection of aseptic drug container seals, Shanghai Zhonglin recommends the use of vacuum attenuation method.
In terms of market situation and product characteristics, the vacuum attenuation method will become the trend of leak detection in the pharmaceutical industry. However, there are only a few enterprises that have vacuum attenuation instruments in China. From the information of some customers on the side of the collapse, the accuracy of the leak detection is not high, and the leaks are not detected. Shanghai Principal's PTI seal tester has high detection accuracy, high sensitivity, short test time, and non-destructive testing, which saves the company a lot of cost.
Shanghai Zhonglin Electromechanical Equipment Co., Ltd. will hold a technical exchange of integrity testing of sterile pharmaceutical containers at the W4 Hall and M7 meeting room of Shanghai New International Expo Center on October 30, 2013, 9:30-11:30. meeting. The US PTI packaging seal leak detection experts made a wonderful sharing and answered the audience's difficult questions on the spot. This seminar will promote the industry's professional communication of the final treatment of sterile drugs - the integrity test of closed packaging for pharmaceutical packaging. Welcome to the meeting!
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