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Cleaning Validation by Total Organic Carbon Analysis: Instrumental Technology Considerations
Industry: Pharmaceutical
Instrument: Apollo 9000 Total Organic Carbon (TOC) Analyzer, Phoenix 8000 Total Organic Carbon (TOC) Analyzer
The analytical strategy developed to assess the amount of organic residues left on pharmaceutical manufacturing equipment surfaces from product or cleaning agent carryover is known as cleaning validation. Current trends in pharmaceutical manufacturing have seen increasing demand for rapid sample analysis time along with low detection limits for Total Organic Carbon (TOC) analysis in cleaning validation. Through improved technology, U/V persulfate Total Organic Carbon (TOC) analysis today provides the sensitivity for ppb analysis with quick and precise sample analysis. However, even with technology improvements, there are some pitfalls. Some of these areas include high Total Organic Carbon (TOC) “hot” samples, blank variability, and recoveries on clean-in-place (CIP) compounds. Steps to eliminate as many pitfalls as possible for Total Organic Carbon (TOC) analysis along with hints on deciding which Total Organic Carbon (TOC) method is best for your process will be discussed.
Medicines are primarily intended to promote good health; however, when residual compounds remain in the manufacturing processes, the potential for side-effects from toxic levels of contaminants increases. In the past, similar contamination problems in the meat packing industry lead to the creation of the Food and Drug Administration (FDA) for validation of their cleaning procedures. Today, pharmaceutical manufacturers are currently taking steps to prove that their manufacturing equipment is clean and free from contaminants in accordance to the FDA, cGMP, and USP guidelines. One of these steps is replacing old technology with new. On May 15, 1998, USP replaced the Oxidizable Substance test with the modern Total Organic Carbon (TOC) analysis in accordance with USP 23 Chapter <643> Fifth Supplement. In the development of a manufacturer’s cleaning validation program, a company must decide which test will validate their equipment as being clean. For many companies, a large amount of validation sites where water or swab samples are collected must be analyzed on a regular basis, including in-source water. For their applications, Total Organic Carbon (TOC) may provide a fast, accurate means for critiquing their clean in place samples or cleaning validation.
Some qualities that make Total Organic Carbon (TOC) a viable part of a cleaning validation include:
• High Sensitivity
• High Recovery of Samples
• Non-Specific Measurement
• Ease of Use (little method development)
• Minimal Interferences
• Cost Effective
It is critical that one chooses a modern Total Organic Carbon (TOC) technology that will be best suited for their application.
Applications
