Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

Duration: 60 Minutes
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.
Total Organic Carbon Analysis
Instructor: Joy L McElroy
Product ID: 509928
Objectives of the Presentation
  • 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 solubilise compounds
  • Learn appropriate uses of TOC throughout the validation life cycle
  • Benefits of at-line and on-line sampling
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 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
  • 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 will Benefit
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
Topic Background
Total organic carbon (TOC) analyzers are a mainstay in industries that must detect and quantify carbon content from many samples and sources. Unlike spectroscopy, which measures specific carbon species from their unique interactions with light, TOC analysis doesn't tell which specific carbon-containing species are present. Nevertheless, it does provide information on impurities, which is invaluable in evaluating environmental samples. TOC analysis is mandatory for many labs, particularly in semiconductors for process water; or in regulated industries that work with ultrapure water for processing, instrumentation, cleaning/ cleaning validation, or human drugs. Other industries that regularly employ TOC analysis include pharmaceuticals, foods, forensics, oil and gas, and the life sciences.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest.

Her knowledge, experience, and strong work ethic 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.

In 2013 Joy started, Maynard Consulting Company, which provided engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States.

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, Canada, and the world.

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.
View More