Cleaning Memo PDF Files

Cleaning Memos from October 2000 through December 2011 are available in electronic format. A zipped file for a given volume has each Cleaning Memo as a separate PDF, and all Cleaning Memos for that volume together as one PDF. You may purchase individual volumes or you may purchase one zipped file that has all individual Cleaning Memos from October 2000 through December 2011 (Volumes 1-11). In addition to each individual Cleaning Memo as a PDF, the comprehensive zipped file also has all Cleaning Memos as one PDF. One advantage of the electronic format is that it enables you to do word searches.

There are two options for purchasing Cleaning Memos in electronic format. Option A is to purchase the files for loading onto one computer, without network access. This option allows the purchaser to print up to two copies of each Cleaning Memo for use by that company. Option B allows use on either multiple computers at one site OR one computer to include including network access at that site for use by that company. This option allows unlimited printing of copies of each Cleaning Memo.  Click here for pricing and order information for the electronic version of Cleaning Memos

For those of you that would like Japanese translations of my Cleaning Memos, these are now available for sale by a third party, GMP Research, in Japan. Here is a link to the web site with purchasing information for Japanese translations of Cleaning Memos: http://www.geocities.jp/gmp_research_jp/


The content of each volume is given below:

Cleaning Memos: Volume 1 (October 2000 to December 2001)

October 2000 The Applicability of Cleaning Validation
November 2000 Campaigns and Dedicated Equipment
January 2001 Specificity of Analytical Methods
February 2001 Validation of Analytical Methods
March 2001 The New FDA Compliance Program Guidance Manual and Cleaning Validation
April 2001 Cleaning for Manufacture of Clinical Trial Materials (CTMs)
May 2001 Setting “Dose” Limits without Dosing Information
June 2001 Water Quality for Validated Cleaning Processes
July 2001 Product Grouping Strategies for Cleaning Validation
August 2001 Equipment Grouping Strategies for Cleaning Validation
September 2001 Handling Sampling Recovery Results
October 2001 Dirty Equipment Hold Times
November 2001 Cleaned Equipment Hold Time
December 2001 What’s a “Dose” for Calculating Limits?

Cleaning Memos: Volume 2 (January 2002 to December 2002)

January 2002 The Use of Safety Factors in Limits Calculations
February 2002 The Use of Default Limits
March 2002 What’s a Contaminant?
April 2002 Understanding and Applying “Visually Clean”
May 2002 Cleaning Validation for Medical Devices
June 2002 Recovery Studies for Microbial Sampling?
July 2002 Worst-case Process Conditions
August 2002 Selecting Swab Sampling Sites
September 2002 Sampling the Sampling Rinse
October 2002 Recovery Studies for Rinse Sampling
November 2002 Additional Considerations in Recovery Studies Part 1
December 2002 Additional Considerations in Recovery Studies Part 2

Cleaning Memos: Volume 3 (January 2003 to December 2003)

January 2003 More on DEHT Issues
February 2003 Using Sampling Recovery Percentages
March 2003 Is a Dirty Swab a “Visually Clean” Failure?
April 2003 Using Statistics in Sampling?
May 2003 What’s Really Different About Biotech?
June 2003 Limits for Drugs with Multiple Actives
July 2003 Adequate “Documented Evidence” for Cleaning Validation
August 2003 Why TOC is Acceptable
September 2003 Correlation of Swab and Rinse Sample Results?
October 2003 PAT and Cleaning Validation
November 2003 Correlation of TOC with a Specific Analytical Method?
December 2003 Revalidation

Cleaning Memos: Volume 4 (January 2004 to December 2004)

January 2004 Monitoring a Validated Cleaning Process
February 2004 Endotoxin Issues in Cleaning Validation
March 2004 Defining Three “Consecutive” Runs
April 2004 TOC Issues: Part 1 - Sampling Materials
May 2004 TOC Issues: Part 2 - Appropriate Blanks
June 2004 TOC Issues: Part 3 – Blanks for Recovery Studies
July 2004 Cleaning After a Media Fill
August 2004 More on Specificity of Analytical Methods
September 2004 Issues in the Visual Examination of Equipment Surfaces
October 2004 Selecting Worst-Case Products for Grouping
November 2004 Is Rinse Sampling Alone Acceptable?
December 2004 Establishing Adequate Solubility for TOC Analysis
Cleaning Memos: Volume 5 (January 2005 to December 2005)
January 2005 Understanding the Cleaning Process
February 2005 Dealing with Unknown Peaks
March 2005 Cleaning Validation for Packaging Equipment: Part 1
April 2005 Cleaning Validation for Packaging Equipment: Part 2
May 2005 Objectionable Microorganism Concept in Cleaning Validation
June 2005 Setting Limits Based on Process Capability?
July 2005 Revisiting Cleaning Validation for Medical Devices
August 2005 Issues in Limits for Formulated Cleaning Agents
September 2005 More on Limits for Formulated Cleaning Agents
October 2005 Limits for Rinse “Grab” Samples
November 2005 Averaging Swab Sample Results?
December 2005 Selecting the Swab Sampling Area

Cleaning Memos: Volume 6 (January 2006 to December 2006)

January 2006 Acceptance Criteria for Dedicated Equipment
February 2006 Bioburden Proliferation in CEHT Protocols
March 2006 Separating CEHT Protocols from Cleaning Protocols
April 2006 More on Using Rinse Sampling Alone
May 2006 Measuring Bioburden in Protocols
June 2006 Ion Mobility Spectrometry
July 2006 FTIR with Fiberoptic Sampling
August 2006 Surface Roughness and Cleaning
September 2006 CEHT for Sterilized Equipment
October 2006 CV for General Room Surfaces?
November 2006 Use of Sampling Templates
December 2006 Dealing with Deviations in the DEHT

Cleaning Memos: Volume 7 (January 2007 to December 2007)

January 2007 Dealing with Deviations in the CEHT
February 2007 Microbiological Test Method Validation?
March 2007 Limits for Bulk Biotech Manufacture – Part 1
April 2007 Limits for Bulk Biotech Manufacture – Part 2
May 2007 Revisiting Medically Safe Limits
June 2007 Issues in Campaigns
July 2007 Spiking Amounts for Sampling Recovery Studies
August 2007 Master Plans vs. Policies
September 2007 TOC Analytical Method Validation
October 2007 Downsides to TOC?
November 2007 Measuring Residues of Volatile Solvents?
December 2007 More on Limits for API Manufacture

Cleaning Memos: Volume 8 (January 2008 to December 2008)

January 2008 Can Protocols Use Limit Tests?
February 2008 A Stroll Down Memory Lane
March 2008 Canada’s Revised Guidelines
April 2008 What Have We Learned in the Last Two Decades?
May 2008 More on Floors and Walls
June 2008 Still More on Floors and Walls
July 2008 What’s Happening to Revalidation?
August 2008 Do Three Verifications Make a Validation?
September 2008 Sampling Recovery for Biotech
October 2008 Are We Setting Limits Correctly?
November 2008 Limits for Topicals
December 2008 Solvent Reflux Sampling Recovery

Cleaning Memos: Volume 9 (January 2009 to December 2009)

January 2009 Limits for Rinse “Grab” Samples
February 2009 Another Alternative for Rinse Sampling Limits
March 2009 Differing Ways to Express Limits
April 2009 What’s Happening to Worst-case Process Conditions?
May 2009 The Science Behind Limits
June 2009 Use of Alkali/Acid Cleaning Agents in Biotech
July 2009 Revisiting Linearity of Swab Recovery Results
August 2009 The Changing Paradigm for Cleaning Validations
September 2009 “Design Space” for Cleaning Processes
October 2009 Use of Multiple Swabs for Sampling
November 2009 “Continued” vs. “Continuous” Process Verification
December 2009 The Rationale for Rinse Sampling for Cleaning Agents

Cleaning Memos: Volume 10 (January 2010 to December 2010)

January 2010 What’s an “Equivalent” Swab?
February 2010 Revisiting “Cleaning Verification”
March 2010 Basics of “Stratified Sampling”
April 2010 More on “Stratified Sampling”
May 2010 Final Notes on “Stratified Sampling”
June 2010 Acceptable Variability for Sampling Recovery Studies
July 2010 Statistics for Visual Limits
August 2010 Visually Clean and Visual Limits
September 2010 More Uses for Visual Limit Determination
October 2010 Swab Sampling Recovery as a Function of Residue Level
November 2010 A Critique of Cleaning Validation Issues in ISPE’s RiskMaPP
December 2010 Understanding the Cleaning Process in 2010 (and Beyond)

Cleaning Memos: Volume 11 (January 2011 to December 2011)

January 2011 More on Campaign Length
February 2011 More on ISPE’s Risk-MaPP
March 2011 What Does the FDA Process Validation Guidance Say about the Number of Qualification Runs
April 2011 A Conundrum Regarding Limits
May 2011 An Alternative Swab Recovery Procedure
June 2011 Manual Cleaning Issues – Part 1
June 2011 Addendum Where Risk-MaPP Got It Wrong
July 2011 Manual Cleaning Issues – Part 2
August 2011 More on an Alternative Swab Recovery Procedure
September 2011 Limits Below the LOD in Rinse Solutions – Part I
October 2011 Limits Below the LOD in Rinse Solutions – Part II
November 2011 Limits Below the LOD in Rinse Solutions – Part III
December 2011 The Good, the Bad and the Inexplicable of Risk-MaPP