Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

Cleaning Memo Topic Index

Analytical method validation:

September 2007
February 2007
February 2001 Validation of Analytical Methods

Analytical methods:

June 2017
August 2013
July 2013
May 2012
November 2011
October 2011
September 2011
January 2008
July 2006
June 2006
February 2005
August 2004
January 2001 Specificity of Analytical Methods

Analytical methods – TOC:

May 2012
October 2007
September 2007
December 2004
June 2004
May 2004
April 2004
November 2003 Correlation of TOC with a Specific Analytical Method?
August 2003 Why TOC is Acceptable

API manufacture:

September 2017
January 2017
June 2016
May 2016
April 2016
December 2007

Biotech issues:

June 2009
September 2008
April 2007
March 2007
June 2005
May 2003 What's Really Different about Biotech?

Campaigns:

May 2012
January 2011
June 2007
November 2000 Campaigns and Dedicated Equipment

Clean Hold Time:

April 2017
June 2012
February 2012
April 2008
January 2007
September 2006
March 2006
February 2006
November 2001 Cleaned Equipment Hold Time

Cleaning agents:

May 2012
December 2009
June 2009
April 2008
September 2005
August 2005

Cleaning procedure:

September 2016
January 2016
November 2015
December 2010
August 2006
January 2005

Cleaning verification:

April 2012
February 2010
November 2009
August 2008
January 2008
April 2001 Cleaning for Manufacture of Clinical Trial Materials (CTMs)

Clinical trials:

May 2001 Setting "Dose" Limits Without Dosing Information
April 2001 Cleaning for Manufacture of Clinical Trial Materials (CTMs)

Continuous manufacture:

April 2014

Dedicated equipment:

October 2017
May 2012
January 2006
November Campaigns and Dedicated Equipment

Design/development of cleaning processes:

December 2014
September 2009
August 2006
January 2005

Dirty Hold Time:

April 2017
February 2012
December 2006
January 2003 More on DEHT Issues
October 2001 Dirty Equipment Hold Times

Endotoxin issues:

February 2004

GRAS:

July 2015

Grouping – Equipment:

June 2014
November 2012
August 2001 Equipment Grouping Strategies for Cleaning Validation

Grouping – Product:

November 2017
May 2017
October 2004
July 2001 Product Grouping Strategies for Cleaning Validation

Highly Hazardous Actives:

February 2015
June 2012

History (of cleaning validation):

February 2008

Indirect product contact surfaces:

October 2014
September 2014
August 2014
October The Applicability of Cleaning Validation

Limits (general):

December 2017
December 2016
November 2016
July 2016
March 2013
October 2012
September 2012
November 2011
October 2011
September 2011
April 2011
May 2009
March 2009
November 2008
October 2008
January 2008
December 2007
January 2006
June 2005
March 2002 What's a Contaminant?
February 2002 The Use of Default Limits
January 2002 The Use of Safety Factors in Limits Calculations

Limits – actives:

October 2016
June 2003 Limits for Drugs with Multiple Actives
December 2001 What's a "Dose" for Calculating Limits?
May 2001 Setting "Dose" Limits Without Dosing Information

Limits – ADE:

“Risk-MaPP”
“Limits – health-based”

Limits – PDE:

“Limits – health-based”

Limits – bioburden:

February 2007
May 2005

Limits – biotech:

March 2017
February 2017
April 2007
March 2007

Limits – cleaning agents:

January 2014
November 2007
September 2005
August 2005

Limits – health-based:

January 2018
December 2017
August 2017
July 2017
July 2016
March 2016
September 2015
August 2015
May 2015
April 2015
March 2015
May 2014 addendum;
December 2013
November 2013
May 2013
March 2012

Limits – preferential transfer :

July 2014

Limits – rinse sampling:

May 2013
April 2013
February 2009
January 2009
April 2008
October 2005

Limits – swab sampling:

November 2005

Limits – stratified sampling:

May 2010
April 2010
March 2010

Limits – TTC:

May 2007

Lyophilizers:

October 2014
September 2014
August 2014

Manual cleaning issues:

July 2011
June 2011

Master plans:

August 2007

Media fills:

July 2004

Medical devices:

July 2005
May 2002 Cleaning Validation for Medical Devices

Mock Soil/Soiling:

February 2014

Monitoring:

August 2013
July 2013
January 2004

Non-product contact surfaces:

June 2008
May 2008
October 2006

Packaging (filling) equipment:

April 2005
March 2005

Parts washer:

January 2012

PAT (continuous process verification):

November 2009
October 2003 PAT and Cleaning Validation

Placebo cleaning:

September 2016

Placebo sampling:

August 2016

Process validation:

August 2012
March 2011
November 2009
August 2009

Protocol worst cases:

April 2009
July 2002 Worst-Case Process Conditions

Protocols:

February 2016
March 2011
August 2008
March 2006
March 2004
July 2003 Adequate "Documented Evidence" for Cleaning Validation

Recovery (general):

June 2010
September 2008
April 2008
July 2007
June 2004
February 2003 Using Sampling Recovery Percentages
December 2002 Additional Considerations in Recovery Studies Part 2
November 2002 Additional Considerations in Recovery Studies Part 1
September 2001 Handling Sampling Recovery Results

Recovery – bioburden sampling:

June 2002 Recovery Studies for Microbial Sampling?

Recovery – rinse sampling:

October 2013
January 2013
October 2002 Recovery Studies for Rinse Sampling

Recovery – solvent reflux sampling:

December 2008

Recovery – swab sampling:

September 2013
December 2012
August 2011
May 2011
October 2010
June 2010
October 2009
July 2009

Recovery for volatiles:

May 2014

Regulatory documents/issues:

June 2015
March 2011
December 2010
August 2009
July 2008
March 2008
January 2005
July 2003 Adequate "Documented Evidence" for Cleaning Validation
March 2001 The New FDA Compliance Program Guidance Manual and Cleaning Validation

Revalidation:

July 2008
December 2003 Revalidation

Risk MaPP:

January 2018
December 2017
February 2013
October 2012 addendum
March 2012
December 2011
July 2011 addendum
February 2011
November 2010
May 2009
October 2008

Sampling:

May 2005
April 2004
April 2003 Using Statistics in Sampling?

Sampling – bioburden:

April 2008
May 2006

Sampling hold time:

February 2012

Sampling – rinse:

October 2015
December 2009
February 2009
January 2009
April 2006
November 2005
November 2004
September 2003 Correlation of Swab and Rinse Sample Results?
September 2002 Sampling the Sampling Rinse

Sampling – swab:

October 2015
January 2010
October 2009
November 2006
December 2005
November 2005
September 2003 Correlation of Swab and Rinse Sample Results?
March 2003 Is a Dirty Swab a "Visually Clean" Failure?
August 2002 Selecting Swab Sampling Sites

SIP:

September 2006
May 2006

Solvents (organic):

November 2007

Statistics:

July 2010
June 2010
November 2005
April 2003 Using Statistics in Sampling?

Test Until Clean:

March 2014

Topicals:

November 2008

Unknown peaks:

February 2005

Validation maintenance:

November 2009

Visually clean:

December 2015 Special Cases in Determining "Visually Clean"
January 2015 Regulatory Status of "Visually Clean Alone"
September 2010 More Uses for Visual Limit Determination
August 2010 Visually Clean and Visual Limits
July 2010 Statistics for Visual Limits
September 2004 Issues in the Visual Examination of Equipment Surfaces
March 2003 Is a Dirty Swab a "Visually Clean" Failure?
April 2002 Understanding and Applying "Visually Clean"

Water activity:

July 2012 Significance of Water Activity for Cleaning Validation

Water quality:

June 2001 Water Quality for Validated Cleaning Processes

White rings (buffer tanks):

November 2014 White Rings in Buffer Tanks?

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