Newsletter | December 2, 2021

12.02.21 -- Facility Monitoring Solutions And How To Implement Them

Choosing Cleanroom Sampling Point Locations

When considering where to place sample points for particle monitoring, whether it will be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.), the answer is not always straightforward. Here, we help to identify the considerations, establish the most suitable location for monitoring a process, and build a scientific rationale for that decision.

Alarm Rationale For Continuous Particle Counting Systems

A shift to continuous particle monitoring can yield an ocean of data. With this description of current good manufacturing practices (cGMPs) and how they can be applied to a continuous monitoring system, your teams can establish new monitoring understandings and harmonization with standards. We further explain the configuration of alert and action levels and potential reactions and the reporting requirements of such systems.

EU GMP Annex 1: Nonviable Environmental And Process Monitoring Insights And Updates

The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. This paper covers many of the new EU GMP Annex 1 topics including system design, monitoring, cleaning and disinfection, risk assessment, microflora, events, and deviations.

Considerations And Steps For Building A Contamination Control Strategy

Contamination control strategies (CCS) are designed to prevent and control potential contamination from reaching the point of no return: the product. Once contamination occurs, there is no cost-effective removal scheme to continue production, making the determination of sources even more important. Learn how to create an effective CCS.

Leveraging Microbial Contamination Monitoring Data For Actionable Insights To Meet And Exceed The Auditor’s Expectations

Modern pharmaceutical manufacturers are already generating and managing Big Data from environmental monitoring; the next step is to create actionable insights and ensure 21CFR11 compliance. This webinar discusses data collection, 21CFR11 data management, and the generation of actionable insights.

Pharmaceutical Cleanroom Environmental Control

Monitor your viable and non-viable particles according to the most recent regulatory requirements. Count, report, document, and manage your pharmaceutical environmental monitoring data meeting 21 CFR Part 11 data integrity requirements.

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FacilityPro® Cleanroom Software

FacilityPro® Cleanroom Software provides the interface, data management, and reporting for an environmental monitoring system. FacilityPro’s ability to manage viable, nonviable, and environmental data through a common system improves the efficiency of production operations and quality investigations.

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