Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

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.

Why You Should Attend:

TOC (total organic carbon) analysis is one of the most common analytical methods used for cleaning validation in the pharmaceutical industry. This nonspecific 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, by-products, 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.

This webinar will demonstrate 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.

Areas Covered in the Session :

  • Principles of Total Organic Carbon Analysis
  • Description of analytical approaches in different instruments
  • Reasons for using TOC and Situations where TOC is preferred
  • Setting limits based on TOC
  • Use of blanks and controls
  • Grouping strategies for Analytical method validation
  • Dealing with interferences and Optimization of TOC recovery for difficult to oxidize or solubilise compounds
  • Cautions to be taken in sampling and analysis
  • Use of TOC throughout the validation lifecycle
  • Regulatory issues

Who Should Attend:

Attendance will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control, and Quality Assurance personnel.

Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course.

  • QA and QC managers
  • QC Analysis Technicians
  • Disinfectant validation managers
  • Operations managers
  • Manufacturing operators
  • Clean room managers
  • Clean room operators
  • Personnel and contractors that clean and disinfect clean rooms
  • Regulatory compliance managers and environmental monitoring managers
  • EH&S managers
  • Validation Engineers and Specialist

FDB2752

Joy McElroy

Joy McElroy offers 14 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.