Archived On Demand Webinars

Combining Particle and Microbial Sensors to Fully Meet Regulatory Requirements

Monitoring of nonviable and viable particles in a cleanroom is critical to meet regulatory requirements. An environmental monitoring system effectively collects, manages and reports on data from both types of sensors. 

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Steps to Ensuring a Successful Audit - Effective Risk Assessment Design Webinar

When designing a process, product quality is an important measure of success. To ensure product quality, it is imperative that the environment is monitored for contamination.

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Effective Compressed Gas Contamination Monitoring: Particles and Microbials

Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring of particles & microorganisms in manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators consists of clearly defined components.

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The Significance and Detection of VBNC Microorganisms

Microbiologists have long recognized there are significant numbers of microorganisms in the environment that cannot be cultured successfully with conventional methods. A wide range of nonsporulating gram-negative and gram-positive bacteria can exist in the Viable But Non Culturable state.

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Understanding ISO 21501-4: Particle Counter Calibration

ISO 21501-4 has two main goals; to improve instrument-to-instrument data correlation and count accuracy, and to enhance compliance with ISO 14644.

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Understanding ISO Standards: 14644-2:2015 Cleanroom Monitoring (English)

Learn about ISO 14644-2:2015 and how it affects your clean environment monitoring.

ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control.

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ISO 14644-1:2015 Revisions Summary

Learn about ISO 14644-1:2015 and how it affects your clean environment monitoring.

The recent revision of ISO 14644-1 introduced several changes for cleanroom classification and monitoring guidelines. Join us for a review of the changes and how they affect your environment monitoring.

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Learn efficient troubleshooting techniques for Airborne Molecular Contamination monitoring

Decreasing the time to detect, contain and mitigate very low levels of Airborne Molecular Contamination (AMC) is critical for high tech manufacturers.

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Identifying the best rapid microbial monitoring solution for your critical & ISO 5/ Grade A surfaces

Managers need the assurance that the surfaces in their facilities are aseptic. Gaining that knowledge in a fast and accurate way that also provides results for all surfaces, even and uneven, is a challenge.

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Identifying a safe and reliable microbiological air sampling solution for ISO 5 environments

Personnel pose the greatest risk of false positives in aseptic processing. The BioCapt® Single-Use eliminates false positives and costly investigations by preventing direct operator contact with the media plate.

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Assuring Data integrity in an Environmental Monitoring System

Learn about different options and considerations to protect your data integrity in an environmental monitoring system. 

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Quality by Design and Single-Use Air Sampling Approaches

Quality by Design (QbD) is a well-known concept in the pharmaceutical industry to increase the overall quality of pharmaceutical drugs and increase patient's safety. Controlling the quality of air inside an environmental monitoring program is a vital aspect of managing the risk towards the patient. 

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Controlling Quality in Advanced Optics Manufacturing

Advanced optics manufacturing now requires much cleaner environments than were necessary in the past. This webinar provides an overview of particle generation sources, control methods and ISO standards, to help you achieve a clean environment that maximizes productivity.

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