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Microbial air sampler environmental monitoring biocapt single use sterility assurance
Validation of A Single Use Solution for Environmental Monitoring Microbiology

Aseptic Processing is aimed to maintain the sterility of a product via the assembly from sterile components. It is implemented to prevent microbial contamination.
This poster/paper presents approach as well as the data supporting the validation of a single use microbial sampler impactor including a preloaded agar plate. The BioCapt Single Use is a replacement for agar plates in many instances and support continuous monitoring per EU GMP Annex 1.

Microbial Contamination Monitoring and cleanroom data management Cleanroom Classification v. Cleanroom monitoring
Particle Counter Counting Efficiency

Understanding particle counter counting efficiency helps you to identify the best solution for your application and understand the data from the particle counter. 

All non-volumetric particle counters have sample volume growth to some degree, which results in a lower particle counting efficiency at the lower limit of detection and variable particle counting efficiency across the lower channel sizes. This increase in particle counting efficiency with particle size means the counting efficiency measured at a single particle size in this channel cannot be applied to the entire channel. Use of the particle counting efficiency as a correction factor does not result in “true” particle counts.

Airflow Visualization best particle counter ISO cleanroom standards
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.