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Airflow Visualization
Airflow Visualization Studies: The Impact of Annex 1 (2022) on Sterility Assurance

Understanding critical air patterns and their impacts is paramount to controlling an environment and is a crucial activity in adhering to the relevant regulations. Scientific demonstration is the basis of pharmaceutical GMP regulatory compliance, and the best way to demonstrate air patterns is through airflow visualization studies (also known as smoke studies). If unidirectional airflow (UDAF) is used as a tool for mitigating the risk of contamination, a company must demonstrate its effectiveness through such studies.

Continuous Monitoring Concept
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
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.

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