Freeze-dried powder injection aseptic assurance level should attract the attention of the industry

China Drying Network News China National Food and Drug Administration Drug Certification Management Center held a meeting on the quality control of freeze-dried powder injection production in Shanghai. This is the last of the three quality control on-site conferences organized by the Center for Drug Certification and Management organized by the Center for Drug Certification and Management. Prior to this, quality control meeting for the production of traditional Chinese medicine injections and large volume injections was held in Shijiazhuang and Chengdu respectively. The Drug Certification Management Center conducted inspections on 151 pharmaceutical production companies for certification. It has so far attracted 124 newly approved GMP inspections. Among them, 33 large-volume injections have passed GMP certification, and 22 freeze-dried powder injections have been used. 5 homes.

Taking lyophilized powder as an example, there are currently nearly 500 freeze-dried powder injection production workshops in China. In other words, the number of companies that have passed the newly revised GMP certification is still less than 1/10. A lyophilized powder injection is an injection powder prepared by freeze-drying a drug solution after aseptic filling. It is reported that from the current enterprise media simulation filling validation work, some companies have not fully covered the verification to the worst condition of normal production (the longest filling time, personnel shifts, and halfway filling materials affect product quality), and verification The frequency is low. The upgrades and upgrades in environmental monitoring and other aspects are also uneven and do not reflect the practical application of the concept of quality risk management. Experts at the meeting pointed out that lyophilized powder for injection sterility assurance level should be particularly worthy of our attention.

At the meeting, Shanghai First Biochemical Pharmaceutical Co., Ltd., Livzon Group Livzon Pharmaceutical Factory, Jiangsu Aosikang Pharmaceutical Co., Ltd., Hangzhou Australasia Biotechnology Co., Ltd., Zhejiang Hisun Co., Ltd., and Beijing Saisheng Co., Ltd. were introduced at the meeting. Risk assessment and risk management practices.

Freeze drying equipment

Freeze-drying is to contain a large amount of water, pre-cooling and freezing into solids, and then sublimate the water vapor directly under vacuum conditions, and the material itself remains in the frozen ice shelf. Freeze-drying has the following advantages: 1. Freeze-drying is performed at a low temperature and is therefore particularly suitable for many heat-sensitive substances. two. When it is dried at low temperature, some volatile components in the material lose very little, which is suitable for some chemical products, drugs and foods. three. During the freeze-drying process, the growth of microorganisms and the action of enzymes cannot be carried out, so that the original costume can be maintained. four. Since the drying is performed in a frozen state, the volume is almost constant, the original structure is maintained, and no condensation occurs. Fives. The dried material is loose and porous, and it is spongy. It dissolves quickly and completely after adding water, and it almost immediately restores its original properties. six. Since the drying is carried out under vacuum, there is very little oxygen, so some easily oxidized substances are protected. Seven. Drying can eliminate more than 95-99% of the water, so that after drying products can be stored without deterioration. Therefore, freeze-drying is currently widely used in the pharmaceutical industry, food industry, scientific research and other departments.

Shaanxi Huike Botanical Development Co., Ltd. a integrated enterprise which is focus on natural products, plant extract related products and services.We mainly focus on pharmaceutical, functional food, Freeze-dried powder,Natural Pigment,beverages and other business services.

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2022-9-1

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