Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

One of the most useful analytical methods for cleaning validation studies is Total Organic Carbon (TOC). This includes the design, qualification and routine monitoring of the manufacturing process. While there does exist some confusion within the industry and regulatory bodies about the use of this analytical technique, it is widely used because of its assured benefits. This webinar will cover the basis of TOC as an analytical technique, including the several technologies currently being utilized. The precautions 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 a nonspecific method typically being utilized to identify the presence of organic residues on cleaned product contact surfaces. TOC analysis is fast becoming the preferred analytical method of choice for cleaning validation. A number of 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 on Total Organic Carbon (TOC) will demonstrate its feasibility, method validation and transfer from the laboratory to the manufacturing floor. We will also be reviewing the feasibility study of multiple, difficult to oxidize 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

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

Course Director: JOY MCELROY ‎

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence. Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance. In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off – site training to pharmaceutical and biotech companies throughout the United States. Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.