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What Is a Cleaning Validation?

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  • Written By: Malcolm Tatum
  • Edited By: Bronwyn Harris
  • Last Modified Date: 29 October 2016
  • Copyright Protected:
    2003-2016
    Conjecture Corporation
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Cleaning validation is a process that is employed to ensure that any residue left after the manufacture of a given product is removed from the area before additional products are undertaken. Often identified with the work of cleaning and inspecting laboratories owned and operated by pharmaceutical companies, the same general concept is used in other industries in which there is some opportunity for contamination that would either damage the quality of the finished goods or present some type of danger to human life. Along with use in pharmaceutical circles, cleaning validation occurs in such diverse settings as a textile plant and a food preparation facility.

The basic idea behind cleaning validation is to make sure that a work area is free of any contaminants or residue that may have been left from a previous activity. Doing so helps to minimize the potential for any lingering elements from the last project to have a negative impact on an upcoming activity or project. The process itself will often involve efforts to sterilize or at least thoroughly clean the area so that any equipment or work surfaces used are clean and free of contaminants.

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Within the pharmaceutical industry, cleaning validation is essential in protecting the integrity of the medications that are manufactured within a facility. Care is taken to thoroughly clean all equipment used in the manufacturing process, removing any residue that may have accumulated during the production of a given over-the-counter or prescription medication. This is extremely important, since any residue that should find its way into a different medication could interfere with the function of that medication, and possibly trigger negative reactions that could be life-threatening.

In a textile plant, cleaning validation is often necessary as a means of removing any fiber residue that may linger on equipment after running a specific color, merge, and lot of some type of material. This means that before a new color, merge, and lot is run through the same equipment, care is taken to clean the components carefully, removing any residue left from the previous run. Doing so means that the possibility of tiny amounts of residue from a lot of red fiber will not contaminate the upcoming lot of yellow fiber and decrease the quality of that second lot.

In many jurisdictions, specific regulations require that manufacturers engage in some type of cleaning validation. Along with compliance with those basic regulations, many companies also develop and enforce stringent policies and procedures that go above and beyond the standards required by law. Doing so helps to reduce the chances of accidental contamination, enhances the reputation of the business with consumers and in the industry, and in general helps to protect the quality of the finished products.

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