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.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
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