Category: Cleaning

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A Vision of your New and Improved 2022 Cleaning Validation Process

Enter 2022 with the latest knowledge of automating your cleaning validation process and meeting regulations such as Data Integrity. Many are worried about updating their cleaning validation process to meet the latest Annex 1 and other regulations.  You will learn how automation can help you setup your process and how you can continuously optimize your […]

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Current Regulatory Expectations Pertaining to Environmental Monitoring

Current regulatory thinking about environmental monitoring as outlined in the 2020 Draft of EU Annex 1 focuses on risk assessment across all the key elements of the program. This includes understanding airflows to select risk-based sampling sites, criteria for monitoring equipment, level of microbial identification and mainly understanding trends to evaluate facility condition, personnel practices, […]

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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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Risk-Based EM Sampling Strategy – Using the Process Risk Control Strategy to Determine EM Sampling Strategy

Join us as we discuss four different ways of using the process risk control strategy to determine EM sampling.Part 1 – Holistic Process Risk Control Strategy• Process Risk Assessment and establishing a holistic riskcontrol strategy• Environmental risks and risk controlsPart 2 – Environmental CQAs and CPPs• Environmental CPPs and the product CQAs impacted• ISO classifications […]

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Current Initiatives on Visual Inspection in Cleaning Validation

The inspection and release of Pharmaceutical manufacturing equipment, and how this can be accomplished using Visual Inspection, is currently a hot topic in the industry. This webinar will provide background on the new ASTM E3263 “Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues” and its implementation. The […]

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