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Cleaning Compliance Forum: Is Swabbing a Regulatory Requirement?
Author: Jennifer Carlson

Welcome to “Cleaning Compliance Forum.”

This column discusses scientific principles, strategies, and approaches associated with cleaning that are useful to practitioners in compliance and validation. We intend this column to be a valuable resource for daily work applications. The key objective for this column: Useful information.

The topic of cleaning is broad and complex. It involves many different industries and many different disciplines within the organization. Cleaning has applications to pharmaceutical and biotechnology products, medical devices, dietary supplements, cosmetics, and so on—literally every product that is manufactured. Cleaning involves personnel in formulation development, equipment design and installation, processing development, analytical method development, manufacturing, testing, and the quality unit. The importance of cleaning is unquestioned. Cleaning and cleaning validation are often one of the first topics addressed in regulatory audits. Understanding the basic principles of cleaning is fundamental to daily manufacturing, problem investigations, corrective action and preventive action, and other applications. In addition to the diversity of topics in cleaning, its terminology may be esoteric, intimidating, and often unique to various groups in the organization.

These considerations make discussion of cleaning compliance a challenging task. This column addresses the various topics of cleaning with these considerations in mind. We intend to present cleaning topics in a clear and meaningful way so that our readers in different industries and in different areas within the organization will be able to understand and apply the principles discussed.

Reader comments, questions, and suggestions are needed to help us fulfill our objective for this column. Please send your comments and suggestions to column coordinator Jenna Carlson at carlson.jenna@gene.com or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTS
The following key points are addressed in this article:
• Swab sampling is a direct surface sampling technique for sampling surfaces
• Personnel who perform swab sampling should be qualified for performance
• Swab efficiency (i.e., % recovery) for the method and product contact material should be determined
• Extractables from the swab or protein binding to the swab must not interfere with the method
• Swab sampling has advantages and disadvantages
• Global regulatory guidelines describe various direct, indirect, or alternative sampling methods for cleaning validation
• Methods used should be appropriate for their intended use
• Methods used should be based on process soils and the ability to detect the soils
• Cleaning validation programs and the method to detect residues should be based on science and be scientifically established as appropriate methods for use.

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