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Validation of Environmental Monitoring Methods (single user digital version)

By Dawn McIver

PDF Single user
Gov. Price: $30.00Member Price: $55.00Nonmember Price: $69.00
  • Description
  • Table of Contents
  • Author's Bio
This booklet covers the below chapter that is taken from PDA's bestselling Laboratory Validation, and offers a complete overview of a specific topic and provides practical advice for anyone interested in current aspects of laboratory validation.

Validation of Environmental Monitoring Methods

There are many ways to perform environmental monitoring. The methods that a company chooses will determine to a large degree whether or not the data is worth the time and effort spent in collecting and tracking it. In order to show that the methods chosen are appropriate, they need to be validated. Validation is a new concept when it comes to environmental monitoring. Environmental monitoring programs are set up to monitor the effectiveness of cleaning and sanitation and to verify that classified environments are operating in a state of control. This booklet is intended to begin the thinking process and help the reader to design a validation plan that is appropriate for the facility being monitored and the methods being used.

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Format: PDF (1 file - 3.04 MB)

Paper version is not available.

Table of Contents :

I. Surface Monitoring - Background
II. Validation of Surface Sampling Methods
III. Performance Qualification for Contact Plates

  • Part 1: Determining the Percent Recovery of Contact Plates
    IV. Acceptance Criteria for Percent Recovery of Contact Plates
  • Part 2: Determining the Efficacy of the Neutralizers in the Media for Contact Sampling
  • Media for Contact Sampling
    V. Acceptance Criteria for Neutralizer Efficacy
    VI. Performance Qualification of Swabbing Procedures
  • Part 1. Determining if Swabbing Materials have Bacteriostatic/Fungistatic Effect
  • Part 2. Efficacy of the Swab System
  • Part 3. Determining the Efficacy of the Neutralizers used for Swab Sampling
    VII. Other Surface Testing Methods
    VIII. Airborne Viable Monitoring
    IX. Qualifying Environmental Monitoring Methods for Anaerobes
    X. Installation Qualification of Air Samplers (IQ)
    XI. Operation Qualification of Air Samplers (OQ)
    XII. Performance Qualification of Air Samplers (PQ)
    XIII. Airborne Particulate Monitoring
    XIV. Installation Qualification (IQ) for Particle Samplers
    XV. Operation Qualification of Air Samplers (OQ)
    XVI. Performance Qualification of Air Samplers (PQ)
    XVII. Conclusion
    VIII. Bibliography
    IX. About the Author

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