药物分析学报

抽象的

Rapid Assay of Airborne Microorganisms and Bioburden using Several Procedures

Hideharu Shintani

In 2004, FDA Guidance for Industry Pat-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance was issued to urge pharmaceutical makers to advance and enable successful and productive imaginative methodologies in giving quality pharmaceuticals to general society. The linkage of fast microbiological techniques (Rmms) to Process Analytical Technology (Pat) is substantially dependent upon continuous discharge, which is the capability to assess and guarantee the worthy nature of in-technique or last item on the foundation of the accumulation and examination of in-procedure information. As stated in the FDA aide, the Pat segment of ongoing discharge normally incorporates a good blending of evaluated material characteristics and process controls. Material traits for example bioburden, endotoxin content, and sterility could be surveyed utilizing control or alternately circuitous process expository strategies. The joined together process estimations and other test information accumulated throughout the assembling methodology could serve as the premise for ongoing discharge of the last item and might exhibit that every group fits in with to built administrative quality traits. The FDA acknowledges constant discharge to be equivalent with elective systematic systems to the compendial microbiological tests for last item discharge. It is outstanding that the direction record stated that ongoing discharge as characterized in this direction expands parametric discharge of terminally high temperature sanitized pill items. Progressively discharge, material characteristics for example plan, bioburden, compartment size, and stack design, and process parameters for example disinfection parameters, are measured and regulated. In this paper, the creator will endeavor to characterize the part of Rmm in Pat and talk over the requisition of Rmm to aseptic filling, biopharmaceutical upstream and downstream handling, natural screening and control in clean rooms; the choice, improvement, approval, and execution of Rmm for Pat provisions; industry, administrative, and compendial guidelines for Rmm; administrative support of Rmm and time to come of Rmm in pharmaceutical and biopharmaceutical assembling.