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Application Notes (164)
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EU GMP Annex 1 is here,
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Microbial Data Collection environmental monitoring biocapt single use 10 years
Optimal Microbial Sampling of Air Criteria

Microbial sampling of air in pharmaceutical manufacturing facilities is performed using several methods: surface sampling, passive aerosol (air) environmental sampling, and active aerosol (air) environmental sampling. Each of these methods produces a result based on the growth of microbial colonies on the surface of a collection media (typically agar), but the specific instruments and techniques vary between the methods. For all the sampling methods, it is important to be sure that the sample accurately reflects the environmental microbiological condition. This is often measured and discussed in terms of collection efficiency. The focus of this paper will mainly be on active air sampling, but there are sampling characteristics for each type of sampling that ensure the optimized collection efficiency.
Nanoparticle Counter NanoAir 10 for semiconductor tool contamination monitoring
Airborne Nanoparticle Counter to Detect Contamination in Semiconductor Tools

The increasing attention on driving better product yield performance with advanced technology nodes has drawn reasonable discussion for in-tool monitoring to reduce nanoparticles that can have an impact on yield. With that in mind, Particle Measuring Systems (PMS) launched the new NanoAir™ 10 Condensation Particle Counter that measures particles down to 10 nm and the ParticleSeeker™ Smart Manifold system which is the first-ever manifold designed to handle nanoparticle transport. This product will unlock a new world of monitoring possibilities, providing a look into a current blind spot of the requirements and needs in the industry.
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
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.
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.

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