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Hear from industry expert Mark Hallworth, a member of the ISO14644 TR-21 committee. Mark provides an in-depth overview of ISO 14644, focusing on TR-21, and explains the rationale behind the creation of this document. Gain insight into the development of the TR, and explore practical insights designed to aid in its interpretation and application.
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Airflow visualization techniques like Smoke Studies and Computational Fluid Dynamics (CFD) analyses are crucial for contamination control and can support other critical evaluations. Watch to learn how to interpret and leverage the insights generated by airflow visualization to create a comprehensive and effective Contamination Control Strategy (CCS).
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Many GMP standards recommend sampling process gases for contamination before use in critical areas of manufacturing. This step, along with many others that make up a contamination control strategy, contributes to the purity and quality of the final product. Read on to explore relevant regulatory requirements, microbial survival, and more.
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When considering where to place sample points for particle monitoring, whether in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.), the answer is not always straightforward. Learn how to identify the considerations, establish the most suitable location for monitoring a process, and build a scientific rationale for that decision.
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