Pharma TOC Residue Detection Method

Question:
What is TOC and is TOC an acceptable residue detection method for Alconox Brand Aqueous Cleaners?

Answer:
Total organic carbon (TOC) is the amount of carbon bound in an organic compound and is often used as a non-specific indicator of water quality or cleanliness of pharmaceutical manufacturing equipment. A typical analysis for TOC measures both the total carbon present as well as the inorganic carbon. Subtracting the inorganic carbon from the total carbon yields TOC. The United States Pharmacopoeia recognizes TOC as a required test for purified water and water for injection. For this reason, TOC has found acceptance as a process control attribute in the biotechnology industry to monitor the performance of unit operations comprising purification and distribution systems. As many of these biotechnology operations include the preparation of medicines, FDA enacts numerous regulations to protect the health of the public and ensure the product quality is maintained. To make sure there is no cross contamination between product runs of different drugs various cleaning procedures are performed. TOC concentration levels are used to track the success of these cleaning validation procedures especially clean-in-place (CIP).

TOC analysis has been reported to detect the organic surfactants present in ALCONOX (11% w/w), LIQUI-NOX (21% w/w), TERG-A-ZYME (11% w/w), ALCOJET (1.5% w/w), ALCOTABS (20% w/w), DETERGENT 8 (38% w/w), LUMINOX (26% w/w) CITRANOX (17% w/w), CITRAJET (14% w/w), TERGAJET (10.5% w/w) and SOLUJET (6% w/w). You must go through the acid neutralization step or use the inorganic carbon channel on the TOC analyzer to account for inorganic carbon.

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