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