Monitoring a Validated Cleaning Process

Destin A. LeBlanc
Cleaning Validation Technologies, Technical Consulting Services In discussing monitoring for cleaning validation, it is important to carefully define what o­ne means by “monitoring”. As used here, the term “monitoring” refers to the routine measurements taken o­n the cleaning process that serve as indicators of whether the process is in a state of control (or considered from the opposite point of view, serve as indicators that the process either is not or may not be in a state of control). The purpose of monitoring is not to have clear evidence that the surfaces are acceptably clean. To do that, o­ne would have to sample the surfaces (much as o­ne would do in a cleaning validation protocol). Monitoring as discussed here refers to monitoring of an already validated cleaning process.


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TOC Issues: Part 1 - Sampling Materials

Destin A. LeBlanc,Cleaning Validation Technologies,Technical Consulting Services Cleaning Memo for APRIL 2004 This Cleaning Memo will address the proper selection of sampling materials used if Total Organic Carbon (TOC) is the sampling method of choice. Particularly since TOC is subject to a multitude of interferences, it is necessary to make sure that the sampling materials provide a consistent TOC value due to those “interfering” materials. Those materials contribute to the TOC “blank”, and are preferably materials which provide a blank with a low, consistent TOC value.


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Method Development of Swab Sampling for Cleaning Validation of a Residual Active

Pei Yang, Kim Burson,Debra Feder, and Fraser Macdonald
Pharmaceutical Technology, Jan 2, 2005 A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented. The developed extraction method produced an acceptable level of recovery and precision.Cross contamination with active ingredients is a real concern. The Code of Federal Regulations (CFR) states that “Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official, or other established requirements” (1). Cleaning validation is required in the pharmaceutical field to avoid potential clinically significant synergistic interactions between pharmacologically active chemicals (2). Since the issuance of the US Food and Drug Administration’s “Guide to Inspection of Validation of Cleaning Process” in July 1993 (3), cleaning validations have received increasing attention.Validation is required not o­nly for manufacturing sites, but also for the sampling– filling suite in research and development.

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A Roadmap to an Effective Cleaning Program: Validation Considerations

Journal of Validation Technology Once products have been grouped and worst case(s) selected, the next logical question to be answered is "How much product can remain o­n equipment?". There are many bases for establishing limits for cleaning processes. Some of them are.

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CIP/COP Validation Test Procedure

Jon R. Voss
ISPE, September 1999 In the hopes that sharing a test procedure from our library of ValPro™ procedures will get others to do the same, I submit the following procedure for your use. Let us know what you think! Coverage Test-CIP/COPObjective:The objective of this test is to verify that the sprayballs/wands/bars associated with the system are capable of delivering cleaning solutions to all exposed product contact surface areas. Often spray ball coverage testing is performed as part of the final vessel factory acceptance test. Coverage testing may be performed o­n-site using the actual equipment that will be used to clean the vessel.


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