Center for Pharmaceutical Cleaning Innovation
  • Home
    • About
    • Board of Directors
    • Testimonials
  • Research Services
    • Cleaning Process Development
    • TOC Method Development
    • Visual Inspection
    • Statistical Analysis
  • Education
    • Certified SME in ASTM E3106 Science-Based and Risk-Based Cleaning Process Development and Validation
    • Certified Lean Six Sigma Green Belt
    • Publications
    • Training, Seminars, Webinars, Internships
  • Store
    • Cleaning Validation Coupons
    • Cleaning Validation Coupon Information >
      • Materials of Construction
    • Coupon Cleaner
    • CPCI Textbook
  • Donations
  • Contact
  • CPCI™ Software Page
    • HBEL Calculator Page

CPCI's Textbook on Cleaning Validation is now available!!

Picture
This textbook is the foundational text for the CPCI™ certified SME course in the ASTM E3106 "Standard Guide to Science-Based and Risk-Based Cleaning Process Development and Validation" and also for the "Cleaning Validation" course in the RAQA Graduate program at the Temple University School of Pharmacy.
 
The textbook is 403 pages long and contains 31 Chapters on the Science-based, Risk-based and Statistics-based approaches described in the ASTM E3106 Standard. There are also 3 Appendices to provide specific instruction on: "Statistical Tools in Cleaning", "Risk Tools for Cleaning", and "Example Cleaning Risk Assessment". There are 35 pages on Visual Inspection and 20 pages on Total Organic Carbon analysis. The textbook contains case studies with examples of application to real world situations.

Minitab data sets for analysis associated with the textbook will be found HERE on the CPCI™ website.

The textbook can be purchased directly from the CPCI™ webstore following the link below:
 
Cleaning Validation - Science, Risk and Statistics-based Approaches


Table of Contents

Introduction


1- A Brief History of Cleaning Validation                                                                                     
2 - Cleaning Validation: Past, Present and Future                                                                    

Risk (Hazard) Identification

3 - Risk (Hazard) Identification in Cleaning                                                                                  
4 - Chemical Hazards in Cleaning                                                                                                     
5 - Microbiological Hazards in Cleaning                                                                                         
6 - Equipment Design Hazards in Cleaning                                                                                  
7 - Procedural (SOP) Hazards in Cleaning                                                                                    

Risk Analysis

8 - Risk Analysis in Cleaning                                                                                                               
9 - Chemistry and Physics of Cleaning                                                                                          
10 - Cleaning Process Development                                                                                                
11 - Cleanability and "Hardest-To-Clean" Products                                                                   
12 - Selection of Cleaning Agents                                                                                                     
13 - Determination of "Time-To-Clean"                                                                                         
14 - Bench Scale Design of Experiments                                                                                        
15 - Validation of Cleanability Test Results                                                                                    
16 - Setting Science-based Acceptance Criteria                                                                          
17 - The HBEL-Based Toxicity Scale                                                                                                   
18 - Selection of Analytical Methods for the Risk Assessment of Cleaning                      
19 - Recovery Studies in Cleaning Validation                                                                                
20 - Total Organic Carbon Analysis                                                                                                    

Risk Evaluation

21 - Risk Evaluation in Cleaning                                                                                                          
22 - Risk Based Master Planning and Protocol Development                                                
23 - Assessing the Level of Exposure using Process Capability       
24 - Calculating Process Capability of TOC Data                                         
25 - Calculating Process Capability from Censored Data                                                          

Risk Control

26 - Risk Control in Cleaning                                                                                                                
27 - Cleaning FMEAs, the Shirokizawa Matrix and the Cleaning Risk Dashboard           
28 - Statistical Process Control in Cleaning                                                                                    
29 - Visual Inspection                                                                                                                             

Risk Review

30 - Risk Review in Cleaning                                                                                                                
31 - Introduction of New Products                                                                                                   

Appendices
X-I  Statistics and Statistical Tools for Cleaning                                                                            
X-II Risk Management Tools for Cleaning                                                                                      
X-III Example of a Cleaning Risk Assessment                                                                               


The Center for Pharmaceutical Cleaning Innovation is a Non-Profit Research Organization providing research and educational opportunities in Cleaning Process Development and Validation
Content Copyright 2022. All rights reserved.
[email protected]
(908) 507-7743

  • Home
    • About
    • Board of Directors
    • Testimonials
  • Research Services
    • Cleaning Process Development
    • TOC Method Development
    • Visual Inspection
    • Statistical Analysis
  • Education
    • Certified SME in ASTM E3106 Science-Based and Risk-Based Cleaning Process Development and Validation
    • Certified Lean Six Sigma Green Belt
    • Publications
    • Training, Seminars, Webinars, Internships
  • Store
    • Cleaning Validation Coupons
    • Cleaning Validation Coupon Information >
      • Materials of Construction
    • Coupon Cleaner
    • CPCI Textbook
  • Donations
  • Contact
  • CPCI™ Software Page
    • HBEL Calculator Page