Monitoring a Validated Cleaning Process

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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).

Author(s):

Destin A. LeBlanc

Journal:

Cleaning Validation Technologies, Technical Consulting Services

Application of Visible-Residue Limit for Cleaning Validation Richard J. Forsyth and Vincent Van Nost

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Pharmaceutical plants must have visually clean equipment to operate according to good manufacturing practices. Formulators must visually inspect manufacturing equipment for cleanliness before formulation work begins (1). Manufacturers establish and perform visible cleanliness and analytical methods to ensure regulatory compliance. An analyst conducts a visual inspection and confirms visible cleanliness before taking swab samples for chemical analysis (2). The formulator of the subsequent batch conducts a visual inspection before manufacturing work begins. A correlation between available analytical data and visible cleanliness of manufacturing equipment over an extended period of time can expand the practice of performing visual inspections in lieu of swab sampling.

Author(s):

Richard J. Forsyth , Vincent Van Nostrand

Journal:

Pharmaceutical Technology, Oct 2, 2005

Enhancing Drug Development by Applying LC–MS–MS for Cleaning Validation in Manufacturing Equipment

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Currently, liquid chromatograph–ultraviolet spectrometry (LC–UV) is typically applied to cleaning validations because of its familiarity, robustness, ease of use, and regulatory acceptability. For low-dose compounds, equipment requiring low residue limits, and compounds lacking strong chromophores, the enhanced sensitivity and selectivity of liquid chromatography–mass spectrometry–mass spectrometry (LC–MS–MS) facilitates rapid method development for the detection of low levels of residues of active pharmaceutical ingredients (APIs). LC–MS–MS is an acceptable technique for the analysis of API residues for cleaning validation. More importantly, in applications where sensitivity and selectivity are inadequate using traditional modes of detection, LC–MS–MS offers substantial advantages. LC–MS–MS will afford faster development and analysis time, potentially making it the predominant tool of choice.

Author(s):

Kevin J. Kolodsick , Holly Phillips , Jennifer Feng , Matthew Molski , Carol A. Kingsmill

Journal:

Pharmaceutical Technology, Feb 2, 2006

What is Disinfectant Validation?

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Although we commonly talk about "disinfectant validation," the US Food and Drug Administration validates only processes (1). Disinfectants themselves are qualified—that is, found to be effective in the context of a given process, just as we qualify the clean steam supply for an autoclave and then validate the steam sterilization process. The approach to disinfection should be similar, so that a working definition for disinfection process validation would be "establishing documented evidence that a disinfection process will consistently remove or inactivate known or possible pathogens from inanimate objects."

Author(s):

José E. Martinez

Journal:

Pharmaceutical Technology, Mar 2, 2006

Risk-Based Cleaning Validation in Biopharmaceutical API Manufacturing

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Cleaning validation (CV) is driven by regulatory expectations to ensure that residues from one product will not carry over and cross contaminate the next product.1,2 Regulatory scrutiny is more rigorous in a multiproduct facility compared to a single product establishment. Companies are usually cited either for not having a sound cleaning validation or not meeting the protocol acceptance criteria. Because failing a protocol acceptance criteria is considered a substantial regulatory risk, companies are forced to spend money and resources even though there is minimal or no product risk.

Author(s):

Hamid Mollah, Ph.D , Edward K. White

Journal:

BioPharm International, November 2005