Air Archives

The Continuous Monitoring Concept for Pharmaceutical Manufacturing

Continuous monitoring helps ensure the sterility of clean manufacturing within the pharmaceutical industry. In the pharmaceutical field, one of the main objectives required by regulatory guidelines is to preserve the sterility of cleanrooms. Cleanrooms are controlled areas where contamination levels are monitored and managed to meet a defined cleanliness level. To reach this goal, it is important to ensure that each GMP requirement is respected over time.

Particle Loss in Tubing: An Analysis

In discussing acceptable particle losses in tubing, there are many factors. Transportation of particles in tubing between a sample inlet and the optics of particle counters has at many times been at the forefront of discussion regarding the truth of readings. When the validation implications of losses due to various forces are reviewed, the certainty of the result is always in question. So, what are these forces, what are the losses, and what are the acceptable results? This paper addresses these issues to allow for a better understanding of the problem.

Aerosol Particle Monitoring for semiconductor

Real-Time Aerosol Particle Monitoring Inside of Semiconductor Process Tools

Case studies on the use of the Airnet II Particle Counter to improve yields within semiconductor manufacturing.

USP 797 Revision and Impact

The published changes to the chapter are to continue preventing harm through microbial contamination, excessive bacterial endotoxins and inappropriate quality of ingredients. Additionally, USP 797 was updated to reduce risk associated with unintended physical and chemical contaminants, as well as variability in intended strength. Currently, USP 797 is enforceable by the U.S. Food and Drug Administration, as well as 28 State Boards of Pharmacy.