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Section Links: Application Notes l Method Development l Product Specialists

Validating Cleaning Processes: Implementing Total Organic Carbon Analysis to Improve the Process
Instrument: Apollo 9000 Total Organic Carbon (TOC) Analyzer, Phoenix 8000 Total Organic Carbon (TOC) Analyzer

Current trends in pharmaceutical manufacturing have seen increasing demand for rapid sample analysis time along with low detection limits for clean in place (CIP) samples. Total Organic Carbon (TOC) analysis provides a quick, accurate screening alternative for critiquing CIP samples. Some qualities that make Total Organic Carbon (TOC) a viable part of a cleaning validation includes: high sensitivity, high recovery of samples, non-specific measurement, high throughput, ease of use (little method development), minimal interferences and cost effectiveness. In addition, general implementation guidelines for performing cleaning validation using Total Organic Carbon (TOC) will be discussed. Analytical precision and analyte recovery will be investigated for Total Organic Carbon (TOC).

Medicines are primarily intended to promote good health; however, when residual compounds remain in the manufacturing process, potential for side effects from toxic levels of contaminants increases. For this reason, the FDA has recognized, with greater importance, that effective cleaning and sanitizing protocols are a proactive measure in preventing cross-contamination in pharmaceutical and cosmetic production.

As 21 CFR sect 211.67 states, “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.”

A good validation of the cleaning process should document at what point does the cleaning procedure fail when reducing parameters to the worst-case scenario. 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 validation).

Application Note Click here to download this Application Note.

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