Beckman Coulter Life Sciences has introduced the MET ONE 3400+ portable air particle counter to help GMP cleanroom users simplify their routine environmental monitoring and improve data integrity.
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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.
Sterile and antiviral packaging: unlocking the potential of business continuity and resilience during COVID-19 pandemic
Amid the disruptions due to COVID-19, companies providing sterile and antiviral packaging solutions look forward to opportunities arising from the concern over viral exposure itself. Regulatory compliance will play a significant role in the rapidly shifting risk terrain.
Marc Baiget Francesch explains how commensal bacteria can be opportunistic pathogens and why treating them as merely a light threat to cleanrooms can bring disastrous consequences.
QA/QC & Analytical Techniques In-Depth Focus 2020 with a special focus on Chromatography & Microbiology
This in-depth focus highlights how liquid chromatography coupled to mass spectrometry (LC-MS) can be used to characterise proteins, what to do to improve regulatory compliance when using chromatography and the risks posed by underestimating bacterial contaminants in cleanrooms.
Airflow reduction and energy savings achieved in HVAC compared to conventional systems. The challenge of reducing HVAC energy consumption and operation costs without negatively affecting the quality of the finished products, ensuring cleanrooms always conform to required specifications
CLEANING AND microbial contamination control are critical focus areas in the pharmaceutical and medical device industries.
In an effort to prevent harm through contamination, the U.S. Pharmacopeial Convention has been working on a series of proposed changes to USP Chapter 797, Pharmaceutical Compounding– Sterile Preparations.
Expert View: Annex 1 updates: The impact of microbial ID strategy on cleanroom qualifications for pharma manufacturers
Dr Lucia Ceresa discusses the importance of accurate microbial IDs for cleanroom performance qualification and the risks of inaccuracies or failures.
The MiniCapt Mobile Microbial Air Sampler allows the user to perform viable air sampling in cleanroom environments for classification and monitoring purposes.
PharmaIntegrity™ is the definitive solution for managing the collection, analysis, and trending of environmental monitoring data, ensuring timely detection of problems in production, facilitating product release and reducing risks and costs associated with product loss and recalls.
The Lasair III Particle Counter sets the standard for portable aerosol particle counters, and fully meets the requirements of ISO 14644-1 (including the new 2015 revision) and ISO 21501-4.
Application note: FacilityPro® Environmental Monitoring Systems – Data Processing and System Control
The FacilityPro® processor provides the central hub for an environmental monitoring system.