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The question remains for those manufacturers that have qualified their cleaning process using HPLC: What are the best practices when changing from HPLC to TOC analysis for cleaning validation?For manufacturers with validated HPLC methods for cleaning validation, the first step when considering TOC for CV analysis is to examine the feasibility of TOC in lieu of HPLC.Over time, manufacturers, regulatory agencies, and industrial groups have changed focus from HPLC to total organic carbon (TOC) analysis as the preferred analytical method for use in cleaning validation.The reasons for this shift include, but are not limited to, better cleaning process understanding for the life cycle of the equipment, decreased cost, increased productivity, and therefore increased profitability.

One common misconception regarding solubility of APIs for CV with TOC analysis is that solubility is the limiting factor.When setting TOC limit acceptance criteria for CV, a worst-case scenario is assumed.This means the most toxic substance/API, with the lowest maximum allowable carryover (MAC) limit from the previous batch of product, is assumed to contribute all the TOC measured in the cleaning sample.If the recovery or linearity did not pass the acceptance criteria, sample pretreatment using TACT may be necessary.Following the recovery study, the next step is to run a bridge study of actual cleanout samples on the HPLC and TOC instruments side by side.If the existing cleaning cycle has an aqueous solution without any organic solvents in the final rinse, then TOC analysis may be a feasible method.If the existing cleaning process does use organic solvents, can that process be altered to use a final aqueous rinse?Cleanout samples, whether they be rinsate or swab, need to be run in parallel with the HPLC and TOC instruments.The expectation is that the TOC value is equal to or greater than the HPLC value due to the known additional contributions to TOC from detergents, excipients, fillers, etc.In a scenario in which the HPLC results pass but the TOC results fail acceptance criteria, the value of process understanding is highlighted using TOC analysis.The use of HPLC quantitation of API to release equipment to production may result in carryover of residual soils from other sources.

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  1. Challenge. A leading BioPharma manufacturer of life-sustaining proteins that minimize the effects of chemotherapy faced cleaning validation challenges. This company's mature, validated production facility used state- of-the-art technology to ensure its processes ran smoothly, safely, and cost-effectively. For example.

  2. Most biopharmaceutical process components e.g. API, host cell proteins, media, and cleaning detergents include organic carbon within their composition. The application of TOC as the post-cleaning detection method for product carryover is considered more stringent than a product-specific method as it would detect all.

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