The Journal of Validation Technology
Vol. 17, Issue 1, Feb 2011

It is critical to determine the amount of residue that remains on product contact surfaces after cleaning to assess whether the equipment is safe for use in subsequent pharmaceutical manufacturing. This is accomplished through the successful execution of cleaning validation protocols, which are mandated by various government regulations. There are two types of sampling techniques commonly used in cleaning validation...
John A. Wass
The following key points are discussed: Design of experiments (DOE) consists of three basic stages: screening to identify important factors, response surface methodology to define the optimal space, and model validation to confirm predictions. A critical preliminary step in the screening stage is for subject matter experts to identify the key...
Gregory P. Martin
Vivian A. Gray
The following key points are discussed: The dissolution method is important because it is the only test that addresses product performance. Dissolution methods may be used for different purposes, and the method development process should address these specific goals. The validity of the dissolution test must be demonstrated.
Bernard McGarvey
Brian K. Nunnally
John McConnell
The following key points are discussed: Good science in discovery, development, production, and in laboratories requires stable operations with low variation. Unstable analytical systems signals from the analytical process add variation to production data. Actual examples of variable processes are presented. “Stabilize first” is the first...
Eric Olson
Image analysis is one method by which particle size may be measured. In many cases, it is considered the “gold standard” of particle size measurement and is often used to verify the results of other techniques. Sample particle size distributions are often broad, sometimes covering two to three decades of particle diameter. It is also common to...
Paul L. Pluta
Timothy J. Fields
The following key points are discussed: Test data and results generated as specified in the validation protocol are critical because they provide the basis for the final validation report and the judgment that the item of interest is validated. Data recording and associated documentation for validation may not meet expected quality standards...
Scott Sutton, Ph.D.
The following key points are discussed: Quality control (QC) microbiology tests require controlled levels of inocula and require fresh preparations of cells for those inocula The concentration of cells in a suspension can be estimated by optical density, but this must be confirmed by plate count The optical density readings against cell mass...
Paul L. Pluta
The following key points are discussed: The site validation approval committee (VAC) has a vital responsibility to the manufacturing site and is critical to the success of the site validation program The site VAC has three primary responsibilities: technical excellence, compliance, and documentation Clearly identifying the responsibilities of...
Methodologies for characterizing and enhancing the performance of cleaning processes are described in this series. The fundamentals of cleaning performance characterization are discussed in Part I. The development and application of experimental models to assess and enhance performance will be discussed in subsequent parts.
John E. Lincoln
The following key points are discussed: Changes requiring a new 510(k) are a source of much confusion If a device has significantly changed, a new 510(k) is required The cumulative effect of multiple minor changes may cause the manufacturer to decide that a device has been significantly changed The US Food and Drug Administration does not...
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