New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock…
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Airborne particle counting
New study suggests that Tryptone Soya Agar (TSA) settle plate desiccation during exposure can reduce recovery of airborne microbes.
Here, EPR summarises Dr William Whyte’s guidance for formally selecting cleanroom monitoring locations and action levels.
Researchers used computational fluid dynamics (CFD) simulations to assess their cleanroom airflow and suggest improvements that would reduce contamination levels.
Research suggests the adoption of microbial air samplers to overcome COVID-19, as well as the growth of the pharmaceutical sector will both drive market development.
FDA provides guidance on the validation and regulations for bio-fluorescent particle counting technology as an alternative, continuous method for bioburden testing in air and water systems.
New MET ONE 3400+ air particle counter automates routine environmental monitoring for GMP cleanroom compliance
Integrated electronic SOPs and maps are “all in the box” to help reduce errors.
This In-Depth Focus highlights why bio-fluorescent particle detection is an effective method for enumerating present microbes and discusses ICH Q10 knowledge management; presenting five tips for improving your company’s knowledge management.
Groundbreaking technology could help soldiers on the battlefield and people with skin disorders...
This whitepaper discusses the ISO 14644-1:2015 revisions impacting both the way the cleanrooms are classified and air particle counting instruments...
The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in…
29 May 2014 | By TSI Inc.
This pharma webinar provides an overview of the new PHSS Bio-contamination Monograph and the value of real-time airborne viable particle detection in GMP classified areas.
12 May 2014 | By TSI
TSI Incorporated, the premier provider of particle counting solutions for life science applications, is pleased to announce the submission of a Type V Drug Master File...
Current Rapid Micro Methods (RMMs) for Environmental Monitoring, Validation, and Real-Time Viable Particle Detection
8 April 2013 | By TSI Inc.
This webinar provides an overview of different Rapid Microbiological Methods (RMMs) that can be used for environmental monitoring, their applicability and their pros and cons...