Subject Matter Expert - ASTM E3106 "Standard Guide to Science-Based and Risk-Based Cleaning Process Development and Validation"

        SME CLASSES FOR 2025

October 13th - 17th Click LINK to Register for Class

Class Size is limited to 8 students per class to allow more "hands-on" time and activities and closer interaction with the instructor. Registration is on a "first come-first served" basis.


NOTE: This is a Certification course for Cleaning Validation SMEs and is NOT a beginning or introductory course. This is an intensive training class and covers advanced material.

It is recommended for this course (although not required) that you have a solid science background (BS in Pharmacy, Biology, Chemistry, Engineering, etc.), with a basic understanding of statistics and a prior understanding of Cleaning Validation. If you are unsure if your background is adequate, please contact us.

Prior laboratory experience is very helpful but not required as "hands-on" training is provided. Competence with Excel is necessary. Prior training in Lean Six Sigma principles is very helpful. Experience or familiarity with Minitab® is also very helpful, but not necessary as training is provided.

This 1 week long "Subject Matter Expert" (SME) course provides detailed, "hands-on" training in the new Science-based, Risk-based and Statistics-based approaches found in ASTM E3106-17 "Standard Guide for Science-Based and Risk-Based  Cleaning Process Development and Validation" and includes a copy of CPCI™'s 403 page Textbook "Cleaning Validation - Science, Risk and Statistics-based Approaches". The textbook directly follows the Lecture slides and course outline.

The course takes place over 1 full week (Monday - Friday) at the CPCI™ Laboratory in Hillsborough, New Jersey at regularly scheduled times during the year and includes a continental breakfast, lunch (from local restaurants), breaks and FREE parking.  

The course consists of Lectures on specific topics in the morning followed by "hands-on" Laboratory training on those topics in the afternoon including data analysis of the data generated using Minitab®. (Note: specific training in the Minitab® techniques used in the course will be provided).

The Center for Pharmaceutical Cleaning Innovation (CPCI™), conveniently located in Central NJ, was created to address the challenges associated with implementing and transitioning to the new Science-based, Risk-based and Statistics-based approaches to Pharmaceutical Cleaning found in ASTM E3106 and its supporting ASTM Cleaning Standards. One of these initiatives was to develop a "Subject Matter Expert in Science-Based and Risk-Based Cleaning Process Development and Validation" curriculum and course. This curriculum and course has been developed using CPCI™'s "Cleaning Validation for the 21st Century®" and "Clean6Sigma®" programs and is now available at our Laboratory in Hillsborough, NJ.

Topics covered by both Lecture and Laboratory training include:

• The  4 Hazard Categories - Chemical, Microbiological, Equipment Design and Procedural (SOPs)
• Calculation of Health Based Exposure Limits (HBELs) and and the benefits of using the HBEL approach
• How to create HBEL Monographs using the ASTM E3219
• How to use the CPCI™ FREE Online HBEL Calculator
• Calculation on swab and rinse sample acceptance limits using ASTM E3418.
• Chemistry and Physics of Cleaning (1st Principles)
• Cleaning Process Development using the ASTM G121 Standard Practice and G122 Standard Method and statistical analysis (using the CPCI™ patented high throughput "Little Dipper" device and Model CIP System) 
  • Cleanability Studies 
  • Selection of Best Cleaning Agents
  • Determination of C-Value and "Time-to-Clean" 
  • Design of Experiment (using CPCI's model CIP System and Minitab®)
  • Monte Carlo Analysis using the Transfer Function from the Design of Experiments​

• Risk-based Selection and Justification of Analytical Methods
• Total Organic Carbon Swab Method Development and Validation (includes training on the Beckman Coulter QbD 1200+
• Determination of TOC residues after a CIP Cleaning Run
• Qualification of Visual Inspection using Attribute Agreement Analysis and ASTM E3263
• Risk-based use of ATP (Adenosine triphosphate) swabs for bioburden residues
• Risk and how to apply Risk Assessment to Cleaning and its relationship to Master Planning
• Risk and how to apply FMECAs and HACCP to Cleaning SOPs
• Evaluating cleaning effectiveness using Process Capability and application to Cleaning Data
• How to perform Process Capability using partially or completely Censored data.
• Statistical Process Control (SPC) and its use in Cleaning
• Introduction of New Products (using HBELs, Cleanability studies, and Process Capability with Minitab®)
• CAPSTONE PROJECT - a full Cleaning Validation run will be performed on the selected "Hardest-to-Clean" product identified in the course with TOC swab samples taken and analyzed and Process Capability determined using the HBEL values calculated in the 1st lab and determination of a Cleaning Control Strategy based on the .

At the completion of the course, attendees will be awarded a Certificate of  "Subject Matter Expert in ASTM E3106 Science-Based and Risk-Based Cleaning Process Development and Validation".