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.
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Particle Measuring Systems
The impact of new and alternative monitoring technologies on labor costs in the laboratory and in manufacturing can be significant.
On-demand webinar: Leveraging Data Management for Root Cause Identification in Critical Environments
With the increasing employment of sophisticated Data Management software, the collection and evaluation of multiple data has never been easier! However, managing such a large amount of information may represent a challenge, resulting in a potential obstacle to effective identification of the root cause of the environmental OOS associated deviation…
Release of parental drugs for injection requires test apparatus to be accurate, precise, reliable and compliant with the latest international regulation.
Using the example of a standard Data Management implementation.
Following the patent of the “Espresso” innovative infusion device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a new isolated filling line.
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.
The BioCapt® Single-Use Microbial Impactor is a lightweight, integrated air sampler designed to be used with both portable and remote monitoring systems in remote sampling settings.