Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing is organized by ComplianceOnline.

Description:
In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.

Why Should You Attend:
TOC (total organic carbon) analysis is one of the most common analytical methods used for cleaning validation in the pharmaceutical industry. This non-specific method is typically used to detect the presence of organic residues on cleaned product contact surfaces. TOC analysis is rapidly becoming the analytical method of choice for cleaning validation for several reasons. Many pharmaceutical companies are developing cleaning validation methods based on a whole-product approach: a determination is made as to whether any residue is present without regard to its origin (including products, cleaning detergents, chemicals, solvents, byproducts, degradants, and microbial contaminants). This method works well with TOC analysis, which can detect any API or cleaning agent residue that contains carbon in its molecular structure.

Areas Covered in the Webinar:

Understand the Chemical Basis of TOC Analysis.
Learn how to set limits based on TOC.
Learn how to validate TOC as an analytical method for cleaning validation purposes.
Understand possible interferences from sampling and analysis.
Optimization of TOC recovery for difficult to oxidize or solubilize compounds
Learn appropriate uses of TOC throughout the validation life cycle.
Benefits of at-line and on-line sampling

Topic Background:
Total Organic Carbon (TOC) is a useful analytical method for cleaning validation studies, including design, qualification and routine monitoring. While there may be some confusion with the industry and regulatory bodies about the use of this analytical technique, it is widely used because of certain benefits. The basis of TOC as an analytical technique will be covered, involving the various technologies currently utilized. Cautions in sampling and analyses will be discussed, including the appropriate use of blank and controls.