Source: Shanghai Zhonglin Electromechanical Equipment Co., Ltd. The new version of GMP certification has reached a critical moment in the later period. The status quo is not optimistic. On August 19, the State Food and Drug Administration informed the company that the certification rate of the aseptic pharmaceutical manufacturers was low, and the problem of overcapacity in the pharmaceutical industry was still outstanding. On December 31, 2013, it was the deadline for the aseptic pharmaceutical manufacturer to pass the newly revised “Good Manufacturing Practices†(Drug GMP) certification, otherwise it will be required to stop production. Although sterile pharmaceutical companies have been working hard for certification, the pass rate is not very optimistic. As of the first half of 2013, only 329 of the 1319 aseptic pharmaceutical manufacturers in China passed some of the newly revised Pharmaceutical Production Quality Management Regulations (hereinafter referred to as Pharmaceutical GMP) certification, accounting for only 24.9% of all enterprises. Nearly 80% of sterile pharmaceutical companies are still blocked from the new GMP certification. This shows the difficulty of certification. Every point required by the new GMP can not be ignored. Many drugs are strictly controlled in the production process, but the seal integrity verification after the Zui is easily overlooked. How to ensure the integrity of the non-zui terminally sterilized product sealing system? How to perform container-seal integrity verification? The non-zui terminal sterilized product shall be regarded as being in an incompletely sealed state before being rolled, and the capping shall be completed as soon as possible after the vial is squashed. If you leave the aseptic operating area/room before rolling, appropriate measures should be taken to prevent contamination of the product. Take the products filled with vials as an example. The sealing of the products is determined by the matching degree of the vials and rubber stoppers. To ensure the integrity of the product container-seal, the company should: 1) Select the appropriate sealing system for the product consisting of vials, rubber stoppers and aluminum caps. It should be recognized that the aluminum cover only serves to fix the rubber plug, and the seal of the real product is determined by the vial and the rubber stopper. After the product's sealing system is determined, the positioner-seal integrity verification should be performed. Shanghai Zhonglin Electromechanical Equipment Co., Ltd. recommends non-destructive sealing test. Non-destructive sealing test can greatly improve the testing efficiency of pharmaceutical companies, without destroying packaging and reducing costs, which is a must for the long-term development of enterprises. Risk assessment should be carried out when the specifications or suppliers of the vials, rubber stoppers, and aluminum caps are changed, and the container-sealing system should be re-verified. In order to help the sterile drug company to pass the packaging seal integrity verification process more smoothly. Shanghai Zhonglin Electromechanical Equipment Co., Ltd. is proud to introduce the US PTI VeriPac 455 Seal Tester , which can detect the overall seal and integrity of the entire package or container; detect and confirm the integrity of the package; can test the leakage of dry packaging (freeze-dried , powder needles, etc.); test liquid package leakage (water needle, pre-filled syringe). This seal tester has the following advantages: - Non-destructive, non-destructive, no sample preparation required - Can detect small leaks of 0.05ccm - zui high level of sensitivity, repeatability, accuracy - Conclusions prove better and more reliable than dyeing - Support sustainable packaging, in line with zero waste initiatives - ASTM test methods and FDA standards 2) The purchased vials and rubber stoppers should be strictly controlled according to the quality standards, especially the size and tolerance of the vials and rubber stoppers to ensure that the vials and rubber stoppers have good matching in size and tolerance. Degree, to ensure the product's tightness. At present, some pharmaceutical manufacturers, due to operational problems, insufficient attention or in the process of transformation, still have a wait-and-see attitude towards the newly revised drug GMP certification, and the progress of promoting the newly revised drug GMP certification is slow. According to the current progress and the time limit at the end of 2013, there may be a centralized application for certification in the second half of the year. Given the limited resources for national certification inspections, companies with late application times may be affected. Small and medium-sized pharmaceutical companies urgently need foreign aid. In the face of numerous demands and competitions, whether they have a broad customer base and business promotion capabilities, and promoting their own business in the shortest possible time will be one of the key factors for success. Shanghai Zhonglin Electromechanical Equipment Co., Ltd. will explain the application of the non-destructive seal tester to the audience in the 18th China International Pharmaceutical (Industrial) Exhibition and Technology Exchange Conference (china-pharm 2013), whether it is to pass the new GMP certification. In order to ensure the quality of drugs and improve the shelf life of drugs, the sealing test can never be ignored. In the same period, Shanghai Zhonglin held a technical exchange meeting to share the wonderful leak detection experts on the spot. Welcome new and old customers and friends to visit and exchange. Show information: The 18th China International Pharmaceutical (Industrial) Exhibition and Technology Exchange Conference (china-pharm 2013) Time: 2013.10.29-2013.11.1 Venue: Shanghai New International Expo Center Zhonglin Booth No.: 5418, Hall W5 Seminar information: On October 30, 2013, from 9:30 to 11:30 am, Shanghai Zhonglin Electromechanical Equipment Co., Ltd. will hold a pharmaceutical technology exchange meeting in the M7 conference room of W4 Hall of Shanghai New International Expo Center, which will be shared by the US PTI seal leak detection experts. Packaging seal integrity leak detection related applications, and on-site answer the audience's application challenges. Reprint, please indicate the source: Shanghai Zhonglin Electromechanical Equipment Co., Ltd.
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