Completely revised and updated to reflect the significant advances in pharmaceutical
production and regulatory expectations, this third edition of Validation of Pharmaceutical …

Large-volume parenteral solutions were submitted to heat treatments after being inoculated
with Bacillus stearothermophilus ATCC 7953 (T r= 121° C) and Bacillus subtilis ATCC 9372 …

Microorganisms are living organisms, and the environment in which they live can positively
and negatively affect them. The environmental stress exerted on the microorganism leads to …

This chapter discusses the sterilization validation approach that can be used in the
processing of parenteral products by terminal sterilization using moist heat. The maximum …

The following information outlines a case study pertaining to the engineering and
microbiological activities required for an emulsion product in order to gain FDA approval …

目的建立油浴法测定芽胞悬液形式的湿热灭菌用生物指示剂的D 值以及Z 值.
方法将芽胞悬液密封于玻璃毛细管内, 置恒温的油浴仪内达到灭菌条件, 采用残存曲线法测定 …

Cycle development is the process of determining the physical properties to be met in a
sterilization cycle that will be used to reproducibly and consistently sterilize the product …

抄録 In the development or validation of sterilization process for terminally sterilized
parenteral drugs, biological indicators (BIs) are used to evaluate the effectiveness of …