Environmental Monitoring Handbook For Pharmaceutical Manufacturers

First, learn about the fundamentals of particle counting and cleanroom designs, which helps establish the baseline of the technology being used to manufacture pharmaceutical and life science products in controlled areas. Next, look at the standards applicable to production areas along with the expectations of regulatory bodies governing release to market of aseptic drugs, advanced therapies, medical devices, and non-sterile products. Finally, explore the instrumentation and techniques required to satisfy what is necessary to fulfill quality attributes as defined by the previously mentioned standards and requirements.