Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

Cleaning Memo Topic Index


Analytical method validation:

Analytical methods:

  • December 2018
  • 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:

  • March 2019
  • 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:

Clinical trials:

Continuous manufacture:

  • April 2014

Dedicated equipment:

Design/development of cleaning processes:

  • December 2014

  • September 2009

  • August 2006

  • January 2005

Dirty Hold Time:

Endotoxin issues:

  • February 2004

Equipment - new and used:

  • April 2018

GRAS:

  • July 2015

Grouping – Equipment:

Grouping – Product: 

Highly Hazardous Actives:

  • February 2015

  • June 2012

History (of cleaning validation):

  • February 2008

Indirect product contact surfaces:

Limits (general):

Limits – actives:

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:

  • August 2018

  • July 2018

  • June 2018

  • February 2018

  • 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:

  • January 2019

  • July 2011

  • June 2011

Master plans:

  • August 2007

Media fills:

  • July 2004

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:

Protocols:

  • January 2019

  • May 2018

  • February 2016

  • March 2011

  • August 2008

  • March 2006

  • March 2004

  • July 2003 Adequate "Documented Evidence" for Cleaning Validation

Recovery (general):

Recovery – bioburden sampling:

Recovery – 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:

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:

  • December 2019

  • November 2019

  • 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 2018

  • 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?

Terminology usage:

  • July 2019

  • June 2019

  • May 2019

  • December 2018

  • September 2012

Test Until Clean:

  • March 2014

Topicals:

  • November 2008

Unknown peaks:

  • February 2005

Validation maintenance:

  • November 2009

Visually clean:

Water activity:

Water quality:

White rings (buffer tanks):


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