Month Description
January 2010 What’s an “Equivalent” Swab?
February 2010 Revisiting “Cleaning Verification”
March 2010 Basics of “Stratified Sampling”
December 2009 The Rationale for Rinse Sampling for Cleaning Agents
November 2009 “Continued” vs. “Continuous” Process Verification
October 2009 Use of Multiple Swabs for Sampling
September 2009 “Design Space” for Cleaning Processes
August 2009 The Changing Paradigm for Cleaning Validations
July 2009 Revisiting Linearity of Swab Recovery Results
June 2009 Use of Alkali/Acid Cleaning Agents in Biotech
May 2009 The Science Behind Limits
April 2009 What’s Happening to Worst-case Process Conditions?
March 2009 Differing Ways to Express Limits
February 2009 Another Alternative for Rinse Sampling Limits
January 2009 Limits for Rinse “Grab” Samples
December 2008 Solvent Reflux Sampling Recovery
November 2008 Limits for Topicals
October 2008 Are We Setting Limits Correctly?
September 2008 Sampling Recovery for Biotech
August 2008 Do Three Verifications Make a Validation?
July 2008 What’s Happening to Revalidation?
June 2008 Still More on Floors and Walls
May 2008 More on Floors and Walls
April 2008 What Have We Learned in the Last Two Decades?
March 2008 Canada’s Revised Guidelines
February 2008 A Stroll Down Memory Lane
January 2008 Can Protocols Use Limit Tests?
December 2007 More on Limits for API Manufacture
November 2007 Measuring Residues of Volatile Solvents?
October 2007 Downsides to TOC?
September 2007 TOC Analytical Method Validation
August 2007 Master Plans vs. Policies
July 2007 Spiking Amounts for Sampling Recovery Studies
June 2007 Issues in Campaigns
May 2007 Revisiting Medically Safe Limits
April 2007 Limits for Bulk Biotech Manufacture – Part 2
March 2007 Limits for Bulk Biotech Manufacture – Part 1
February 2007 Microbiological Test Method Validation?
January 2007 Dealing with Deviations in the CEHT
December 2006 Dealing with Deviations in the DEHT
November 2006 Use of Sampling Templates
October 2006 CV for General Room Surfaces?
September 2006 CEHT for Sterilized Equipment
August 2006 Surface Roughness and Cleaning
July 2006 FTIR with Fiberoptic Sampling
June 2006 Ion Mobility Spectrometry
May 2006 Measuring Bioburden in Protocols
April 2006 More on Using Rinse Sampling Alone
March 2006 Separating CEHT Protocols from Cleaning Protocols
February 2006 Bioburden Proliferation in CEHT Protocols
January 2006 Acceptance Criteria for Dedicated Equipment
December 2005 Selecting the Swab Sampling Area
November 2005 Averaging Swab Sample Results?
October 2005 Limits for Rinse “Grab” Samples
September 2005 More on Limits for Formulated Cleaning Agents
August 2005 Issues in Limits for Formulated Cleaning Agents
July 2005 Revisiting Cleaning Validation for Medical Devices
June 2005 Setting Limits Based on Process Capability?
May 2005 Objectionable Microorganism Concept in Cleaning Validation
April 2005 Cleaning Validation for Packaging Equipment: Part 2
March 2005 Cleaning Validation for Packaging Equipment: Part 1
February 2005 Dealing with Unknown Peaks
January 2005 Understanding the Cleaning Process
December 2004 Establishing Adequate Solubility for TOC Analysis
November 2004 Is Rinse Sampling Alone Acceptable?
October 2004 Selecting Worst-Case Products for Grouping
September 2004 Issues in the Visual Examination of Equipment Surfaces
August 2004 More on Specificity of Analytical Methods
July 2004 Cleaning After a Media Fill
June 2004 TOC Issues: Part 3 – Blanks for Recovery Studies
May 2004 TOC Issues: Part 2 - Appropriate Blanks
April 2004 TOC Issues: Part 1 - Sampling Materials
March 2004 Defining Three “Consecutive” Runs
February 2004 Endotoxin Issues in Cleaning Validation
January 2004 Monitoring a Validated Cleaning Process
December 2003 Revalidation
November 2003 Correlation of TOC with a Specific Analytical Method?
October 2003 PAT and Cleaning Validation
September 2003 Correlation of Swab and Rinse Sample Results?
August 2003 Why TOC is Acceptable
July 2003 Adequate “Documented Evidence” for Cleaning Validation
June 2003 Limits for Drugs with Multiple Actives
May 2003 What’s Really Different About Biotech?
April 2003 Using Statistics in Sampling?
March 2003 Is a Dirty Swab a “Visually Clean” Failure?
February 2003 Using Sampling Recovery Percentages
January 2003 More on DEHT Issues
December 2002 Additional Considerations in Recovery Studies Part 2
November 2002 Additional Considerations in Recovery Studies Part 1
October 2002 Recovery Studies for Rinse Sampling
September 2002 Sampling the Sampling Rinse
August 2002 Selecting Swab Sampling Sites
July 2002 Worst-case Process Conditions
June 2002 Recovery Studies for Microbial Sampling?
May 2002 Cleaning Validation for Medical Devices
April 2002 Understanding and Applying “Visually Clean”
March 2002 What’s a Contaminant?
February 2002 The Use of Default Limits
January 2002 The Use of Safety Factors in Limits Calculations
December 2001 What’s a “Dose” for Calculating Limits?
November 2001 Cleaned Equipment Hold Time
October 2001 Dirty Equipment Hold Times
September 2001 Handling Sampling Recovery Results
August 2001 Equipment Grouping Strategies for Cleaning Validation
July 2001 Product Grouping Strategies for Cleaning Validation
June 2001 Water Quality for Validated Cleaning Processes
May 2001 Setting “Dose” Limits without Dosing Information
April 2001 Cleaning for Manufacture of Clinical Trial Materials (CTMs)
March 2001 The New FDA Compliance Program Guidance Manual and Cleaning Validation
February 2001 Validation of Analytical Methods
January 2001 Specificity of Analytical Methods
December 2000 Happy Holidays
November 2000 Campaigns and Dedicated Equipment
October 2000 The Applicability of Cleaning Validation