This booklet covers the below chapter that is taken from PDA's bestselling
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
Paper version is not available.
Table of Contents :Part 1: Determining the Percent Recovery of Contact Plates
Monitoring - Background
II. Validation of Surface Sampling Methods
Performance Qualification for Contact Plates
Acceptance Criteria for Percent Recovery of Contact Plates
Part 2: Determining the Efficacy of the Neutralizers in the Media for
Media for Contact Sampling
V. Acceptance Criteria for Neutralizer
VI. Performance Qualification of Swabbing Procedures
Part 1. Determining if Swabbing Materials have Bacteriostatic/Fungistatic
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
IX. Qualifying Environmental Monitoring Methods for
X. Installation Qualification of Air Samplers (IQ)
Qualification of Air Samplers (OQ)
XII. Performance Qualification of Air
XIII. Airborne Particulate Monitoring
Qualification (IQ) for Particle Samplers
XV. Operation Qualification of Air
XVI. Performance Qualification of Air Samplers (PQ)
IX. About the