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Cleanroom Classification Contamination Control Strategies
Contamination Control Strategies for Innovation FAQ’s

In the pharmaceutical industry, maintaining stringent contamination control is not just a regulatory obligation but a fundamental aspect of ensuring product safety and efficacy. The EU GMP Annex 1 outlines the importance of a Contamination Control Strategy (CCS) for sterile drug products, emphasizing the need for a structured approach to manage risks and maintain compliance. We recently hosted a webinar discussing these strategies in detail. To help navigate this complex field, we’ve compiled a list of frequently asked questions from our experts.

Particle Monitoring Frequency: Frequent or Continuous (Series Part 2 of 4)
Why is 50% the Limit for Particle Counting Efficiency Sizing Thresholds?

Particle counting efficiency is crucial in particle measurement, especially when using optical particle counters. This term denotes the likelihood of precisely detecting and enumerating particles within a specified size spectrum. In this context, the term “counting efficiency” represents the ability of the particle counter to quantify particles of a given size accurately. It measures the instrument’s performance, indicating how effectively it can detect and count particles of various sizes.

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