Cleaning - Kenx Members

Category: Cleaning

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Overcome Top Challenges in Cleanroom Management, Environmental Monitoring and Environmental Cleaning – Insight from the Front Line

Presented by: David W. Vincent, MPH, Ph.D. , Chief Scientific Officer, VTI Takeaways:• The main aspects of a robust cleanroom management program • Challenges with cleanroom design and cleanroom materials of construction • Common deviation root causes for environmental monitoring failures • Cleanroom cleaning causing rouge, rust, and yellowing of surfaces • CAPA to improve […]

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Cleaning Contamination Control Program

Presented by: David W. Vincent, MPH, Ph.D., CEO and Chief Scientific Officer, VTI Life Sciences This Webinar recording will cover the following: Regulatory Requirements: Contamination Control Strategy & Cross Contamination• The view of EU GMP Annex 1• The view of US-FDA: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice• ASTM – […]

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Selection of Analytical and Sampling Methods for Cleaning Validation Based on Analyte Characteristics

Presented by: Michael Lund, Program Manager, Hyde Analytical Laboratories Analytical testing, coupled with a robust sampling method with high recovery, is essential to confirm equipment surfaces have been properly cleaned during cleaning validation or verification. The selection of an appropriate cleaning analytical method is integral to the accuracy of test results generated during cleaning validation […]

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Cleaning Validation Program Design – A Risk-based Lifecycle Approach

Presented by: Matthew Jackson, Head of Quality, Torbay Pharmaceuticals Cleaning Validation Program Design – A Risk-based Lifecycle ApproachDownload

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Analytical Monitoring and Preventative Maintenance of Compendial Water Purification

Bulk compendial water generations systems employ multiple unit operations. Successful long-term controlled operation of individual unit operations for specific removal of one or more contaminants, requires sampling, selective analysis, monitoring and proactive preventative maintenance. Periodic sampling for chemical and microbial attributes, coupled with online monitoring techniques such as a total chlorine analyzer, total hardness analyzer, […]

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