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Archives: Application Notes

isokinetic probe particle counter for unidirectional air.
Isokinetic Probe Particle Counter Air Flow Rate Requirements

There is an optimum air flow rate within unidirectional environments which is required for Isokinetic particle sampling to act as a sheathing air that washes particles from a potential contamination source away from the process risk before being exhausted from the process area. This ensures that this potential contamination does not extend beyond a field of control. This flowrate was historically defined as 90 feet per minute, which roughly converts to 0.45 m/s. Current requirements suggest…
Microbial Data Collection environmental monitoring biocapt single use 10 years air sampler for microbiological monitoring
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
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.