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Topics Discussed:

Microbial Air Sampling in Pharmaceutical Aseptic Monitoring
Discusses and reviews best practices, procedures, and standard recommendations in pharmaceutical manufacturing. Article authored by Climet and published in Cleanroom Magazine
(March-April 2017)

Microbial Air Samplers:
Selection Criteria in Biopharamaceutical Manufacturing

Discusses the seven criteria for selecting a microbial sampler. 
(Jan 2016, pdf, 750KB)

The Implications of ISO/DIS 14644-1.2
ISO/DIS 14644-1.2 draft standard, and implications on the Life Science industry. Article authored by Climet and published in Cleanroom Magazine
(July-Aug 2015, *.pdf, 1.2MB)

Assurance, Accuracy & Integrity: The Forgotten Elements
When choosing acceptable vendors, too often the determination comes down to price, and the reason for buying is often forgotten.
Application Note: 20140930-01
(October 2014, *.pdf, 348KB)

Sources of Cleanroom Particles
The objectives of environmentally controlled cleanrooms are to provide a contamination-free space to test or manufacturer [..]

Cleanroom Monitoring Basics
Discusses basic Validation vs. Monitoring, best practices, standards, and more.

Use of Handheld Particle Counters in FDA & EU GMP Cleanrooms
Discusses the problems with handhelds in cleanrooms, isolators, and biosafety cabinets.

Understanding Zero Count Testing and False Count Rate
Discusses zero count testing.

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