Incorporation of Particle and Microbial Detection into Environmental Monitoring Systems

Incorporation of Particle and Microbial Detection into Environmental Monitoring Systems

03/22/2017, 4:15 PM - 5:00 PM

Meeting Room 1

Language:
English

Monitoring of a cleanroom should be done to meet regulatory requirements for nonviable and viable particles. Contamination may come from humans, manufacturing failures, or outside contamination. Total particle contamination is a mixture of nonviable and viable particles. Historically, nonviable particles are monitored continuously. Viable particles are monitored on a less frequent basis. In modern aseptic manufacturing, both types should be sampled continuously to obtain an accurate indication of the cleanroom's condition. An ideal monitoring program provides the sampling data required and ensures data integrity with the use of an automated system to track any changes. The system used to track and record data must also meet certain requirements, i.e. personnel ID and change details. These actions meet the requirements of 21 CFR Part 11 and should be incorporated into any automated Environmental Monitoring System.

Contributors

  • Paul Hartigan

    Speaker

    Global Product Line Manager Software and Systems

    Particle Measuring Systems

Documents

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. What are the key regulations related to an Environmental Monitoring System. 2. How to incorporate particle and microbial sensors into an Environmental Monitoring System 3. They types of data and reports that should be expected from an Environmental Monitoring System.

Categories

  1. Track
    Leveraging Quality Systems & Strategies in a Heavily Regulated Environment

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