whitepaper
Product hub: How can aseptic manufacturers prevent losses in the millions?
Highest precision with microbial air sampler MAS-100 Iso. So you can focus on the essential.
List view / Grid view
Airborne particle counting
whitepaper
Whitepaper: Designing an environmental monitoring solution for GMP
A review of current environmental monitoring practices to ensure that monitoring systems comply with the latest EU GMP Annex 1 2022.
article
Efficient shutdown recovery: leveraging RMM to unlock value and ensure environmental quality
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…
news
Is plate desiccation impacting microbial monitoring?
New study suggests that Tryptone Soya Agar (TSA) settle plate desiccation during exposure can reduce recovery of airborne microbes.
news
How should environmental monitoring locations be chosen?
Here, EPR summarises Dr William Whyte’s guidance for formally selecting cleanroom monitoring locations and action levels.
news
CFD airflow stimulations can help enhance cleanroom contamination control, finds study
Researchers used computational fluid dynamics (CFD) simulations to assess their cleanroom airflow and suggest improvements that would reduce contamination levels.
news
Is your microbial air sampler fit for purpose?
Here, EPR summarises Tim Eaton’s explanation of the importance of assessing biological collection efficiency when selecting an air sampler.
news
Microbial air sampler market to value $545mn by 2028
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.
news
FDA suggests principles for implementing bio-fluorescent particle counters
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.
news
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.
article
QA/QC & Analytical Techniques In-Depth Focus 2019 featuring Environmental Monitoring
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.
news
Researchers 3-D print electronics and cells directly on skin
Groundbreaking technology could help soldiers on the battlefield and people with skin disorders...
whitepaper
Whitepaper: Changes to GMP force cleanroom re-classifications
This whitepaper discusses the ISO 14644-1:2015 revisions impacting both the way the cleanrooms are classified and air particle counting instruments...
article
Real-time biological particle counting in environmental monitoring
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…
webinar
Bio-Contamination, Risk Profiling and Proactive Response
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.
