Reduce Cleaning Validation Time and Costs by Implementing TOC

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					Reduce Cleaning Validation Time and Costs by Implementing TOC Analysis
S. Proffitt1, B. Wallace2
1
 Marketing, 2Research and Development, Teledyne Instruments - Tekmar
Reduce Cleaning Validation Time and Costs by Implementing TOC Analysis

In the development of a manufacturer’s cleaning validation program, a company must decide which test will validate their
equipment as being clean. Current trends in pharmaceutical manufacturing have seen increasing demand for rapid sample
analysis time along with low detection limits for verification of cleaning validation samples. Total Organic Carbon (TOC)
analysis provides a quick, accurate screening alternative for critiquing cleaning validation samples.

Typical laboratory testing includes the development and implementation of analytical methods that test for residues of
previously manufactured products, cleaning detergents, chemicals, solvents, byproducts, degradants, and microbial
contaminates (from wet environments after the cleaning process). TOC analysis has become one of a series of analytical
methods used to assess the effectiveness of a cleaning validation.
TOC analysis demonstrated equivalent or better correlation to cleaning validation compounds in comparison to traditional
analytical methods. Some qualities that make TOC a viable part of a cleaning validation includes: high sensitivity, high
recovery of samples, non-specific measurement, ease of use (little method development), minimal interferences and cost
effectiveness. This presentation will focus on the characteristics and benefits of TOC with general implementation guidelines
for performing cleaning validation using TOC. Also, information will be provided on which TOC technology is best suited
for cleaning validations.

TOC analysis can be an effective tool for achieving fast, accurate and economical results for one’s cleaning validation
process. Understanding the differences in TOC technology, and choosing the best solution is the key to realizing the benefits
of this technique.