Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

Total organic carbon (TOC) is an analytical method for validation of cleaning processes. TOC helps in detecting and quantifying carbon content from different sources and samples. Many laboratories in regulated industries must conduct TOC analysis, such as those working with ultrapure water in the semiconductor industry, or for processing human and animal drugs as well as cleaning and cleaning validations in the pharmaceutical and life sciences industries.

TOC is one of the most commonly used analytical methods, which helps in cleaning validation in the pharmaceutical industry. It is a nonspecific method and is mostly used in detection of organic residue on product contact surfaces. While some confusion exists within the industry about the use of TOC as a valid method for detecting product residue, it is widely used because of certain benefits. TOC has rapidly gained the status of being the analytical method of choice for cleaning validation. A TOC analysis cannot tell the specific carbon-containing compounds that are present in the sample; however; it provides information on the impurities present, which is extremely helpful for environmental samples. Pharmaceutical companies are working on developing cleaning validation methods that are based on a whole-product approach: which allows companies to determine the presence of residue without knowing its exact origin.

Join this session with expert speaker Joy McElroy, who will demonstrate the feasibility of TOC analysis and method validations, how it can be taken from a lab setting to the manufacturing floor, and how TOC can be used effectively. The webinar will cover the efficacy of TOC for multiple, difficult to oxidize or low solubility organic compounds. This session will cover the basis of TOC as an analytical technique and the various technologies currently utilized and provide insight on appropriate sampling and analysis.

Course Objective:

• The chemical basis of TOC analysis
• Validating TOC for cleaning validation purposes
• Sampling and analysis
• Optimization of TOC recovery
• Benefits of at-line and on-line sampling

Course Outline:

• Total organic carbon analysis: Principles
• 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 solubilize compounds
• Cautions to be taken in sampling and analysis
• Use of TOC throughout the validation lifecycle
• Regulatory issues

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans
• Personnel 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
• Analytical method development personnel
• Quality control personnel
• Quality assurance personnel
• Management staff interacting with the above
• Personnel communicating with regulatory agency inspectors to rationalize or defend cleaning validation programs
• QA and QC managers
• QC analysis technicians
• Disinfectant validation managers
• Operations managers
• Manufacturing operators
• Cleanroom managers
• Cleanroom operators
• Personnel and contractors that clean and disinfect cleanrooms
• Regulatory compliance managers and environmental monitoring managers
• EH&S managers
• Validation engineers and specialists

Joy L. 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.

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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