Air Archives

Microbial Contamination Monitoring and cleanroom data management

Counting Efficiency and Comparison of Particle Counters

Some users believe it is necessary to divide the particle counts of non-volumetric particle counters by the counting efficiency (CE) at the lower limit to establish the “true” concentration of particles in the fluid system. Other users do not understand why two, similar-sized channels of particle counters with different limits of detection do not report the same value. This paper will discuss the science behind these differences and alleviate concerns that come from the characteristics of non-volumetric particle counters.

Bacteria to Consider for the Growth Promotion Test: Should Anaerobic Cultures Be Included?

The purpose of the Growth Promotion Test (GPT) is to determine the appropriateness of the culture media to be used in environmental monitoring sampling. The medium is challenged with a small number of microorganisms to assure the nutritive properties, functionality and media quality are adequate for the detection and enumeration of microbial contaminants.

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.

Condensation Particle Counter and Manifold FAQ

Commonly asked questions are combined with questions submitted during and after the webinar on the NanoAir® and ParticleSeeker® instruments in this document. The questions are answered below by product experts.