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.
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.
Compressed gases, such as nitrogen, carbon dioxide, and oxygen, are used for a variety of applications in pharmaceutical manufacturing. These applications, such as aseptic packaging, purging, and filtration, are critical processes monitored for their efficacy. To avoid sampling compressed gases, it has been speculated by some manufacturers that the rapid decompression of a gas when exiting its container kills any microbial contamination. However, it has been shown by multiple studies that microbial survival is not impacted by the typical compression or decompression seen in pharmaceutical process gases.
A large proportion of products labeled as sterile are manufactured by aseptic processing rather than terminal sterilization. Because aseptic processing relies on the exclusion of microorganisms from the process stream and the prevention of microorganisms from entering open containers during processing, product bioburden as well as the bioburden of the manufacturing environment are important factors governing the risk of unacceptable microbial contamination.
