Risk Control Of Microorganisms In The Air In The Pharmaceutical Preparation Process

Drug is a special commodity closely related with public health. Drug safety is the key matter which involves the national economy and people’s livelihood. Drug safety is a comprehensive system involving all aspects of drug development, production, distribution and use. The quality control of whole process of drugs is an important link, and in particular the preparation process of pharmaceutical production is a top priority. Solid formulations are always in the largest component of the whole pharmaceutical preparations. So, it is necessary to strengthen the administration of solid preparation aiming to enhance the quality control. Microorganism often induced the quality changes in the process of production. Therefore, it must pay attention to the microbes in the process of production control.In the process of pharmaceutical production, the Microbial detection methods include the detection of the amount of the microorganism and suspended particles. The amount of microorganism detection methods, including settling bacteria count, quantitative air planktonic bacteria and surface sampling method, etc., can be optionally selected. The dust particle counting method was used to detect the amount of suspended particles. Sedimentation bacteria detection method was used in this paper to monitor and detect the number of microorganisms in the air for a pharmaceutical A, B, C, D clean area, and settling bacteria, static suspended particles (particle size≥0.5μm and particle size≥5μm), dynamic suspended particles (particle size≥0.5μm and particle size≥5μm) were included. Shewhart control Chart, histograms and other risk management processes, methods and tools were used and many published literature were consulted for risk assessment and analysis of microorganism in the production process for solid preparations, to identify critical control points, conduct risk control, propose improvements, improve product quality, and ensure drug safety of patients.From the results of settling microbe in the D area, many rooms were above the up control line during the July and August, which mainly account for the seasonal factor; from the results of suspended particles,0.5μm、5μm suspended particles were above the up control line more than once. This must be paid more attention to.For the sterile preparations, the detection of the 0.5μm suspended in B regions particles especially the 0.5μm dynamic suspension particles should be firstly paid attention to, secondly the detection of the 0.5μm suspended in A regions particles and the 5μm suspended in C regions particles.According to these results, the author put forward some suggestions.