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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.
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Particle Measuring Systems
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On-demand webinar: Understanding and Applying USP 797
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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On-demand webinar: Increasing Productivity by Leveraging Single Use Technology
The impact of new and alternative monitoring technologies on labor costs in the laboratory and in manufacturing can be significant.
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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…
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On-demand webinar: Complying with USP 729, 788-1788 Regulatory Requirements
Release of parental drugs for injection requires test apparatus to be accurate, precise, reliable and compliant with the latest international regulation.
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On-demand webinar: From Paper to Paperless – Tackling the 21CFR11 Challenge
Using the example of a standard Data Management implementation.
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Video: Parenteral Particle Counting Solution
When it comes to quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste.
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On-demand webinar: Developing an Isolator Filling Line Using a Quality Risk Management
Following the patent of the “Espresso” innovative infusion device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a new isolated filling line.
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Video: MiniCapt® Mobile Active Air Sampler Demo
Learn the features and benefits of the MiniCapt Mobile Active Air Sampler by watching this quick video, presented by Heather Mason of Particle Measuring Systems.
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Application note: MiniCapt® – Mobile Microbial Air Sampler
The MiniCapt Mobile Microbial Air Sampler allows the user to perform viable air sampling in cleanroom environments for classification and monitoring purposes.
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Application note: PharmaIntegrityTM – Cleanroom Data Management System
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.
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Whitepaper: USP <797> Revisions and Impact
The United States Pharmacopeia (USP) is a scientific non-profit organization that sets standards used worldwide for the identity, quality, purity and strength of medicines, food ingredients and dietary supplements.
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Application note: Lasair III® – Aerosol Particle Counter Models
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.
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Application note: FacilityPro® Environmental Monitoring Systems – Data Processing and System Control
The FacilityPro® processor provides the central hub for an environmental monitoring system.
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Whitepaper: Does QRM + RMM = Better EM
Facilities perform environmental monitoring (EM) to demonstrate a state of control.
