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01 According to the requirements of the EU decision tree, if it cannot be sterilized at 121°C for 15 minutes, the residual probability method with F0≥8 can be selected. Excuse me, if the product can be sterilized at 121°C for 12 minutes, can you not choose 121°C for 10 minutes? Similarly,...

Combined with the production characteristics and design points of the chemical raw material medicine workshop, the overall layout, plane layout and steel platform layout of the chemical raw material medicine workshop are analyzed, and the problems that need attention in the design...

1 After Lyophilization And Layering, The Lower Layer Shrank   Phenomenon: After freeze-drying and layering, the lower layer shrinks. Or the entire product shrinks. Some of the product freezes well, some shrink into very few almost empty bottles Possible cause analysis and solution:...

Objective: To provide a reference for the detection of seal integrity in injection consistency evaluation.   Methods: Based on literature research and combined with practical work experience, the relevant research on the existing injection packaging seal integrity detection technology...

01 Terms Related To Common Routes Of Administration   (1) Intra-Venous, IV: Commonly used injection sites include the basilic vein, median vein, and cephalic vein of the cubital fossa.   (2) Intra-Aterial, IA.   (3) Intra-cutaneous, IC; Intra-dermal, ID: The drug is...

Oral solid dosage forms are still the most commonly used drug dosage form in the world pharmaceutical industry. Oral solid dosage forms will continue to grow in the near future. This article points out that the major challenge currently affecting drug development in the world is overcoming...

In recent years, with the gradual maturity of peptide synthesis technology and the continuous improvement of pharmaceutical preparation technology, peptide drugs have attracted extensive attention from domestic and foreign researchers, and related research and development work has...

In order to explore the effect of different sterilization methods applied in the purified water system, three sterilization methods including chlorine dioxide sterilization method, ozone sterilization method and pasteurization method were selected. After clarifying the specific operation...

Investigate the development status of the domestic pharmaceutical packaging industry, and propose improvement plans for the problems of poor stability and low measurement accuracy of the automatic filling production line of small and medium-sized pharmaceutical manufacturers, which...

Part 1 Introduction   Sterile drugs can be divided into terminally sterilized products and non-terminal sterilized products according to different production processes. The latter needs to be produced using aseptic production processes because the semi-finished products cannot...