Destin A. LeBlanc

Cleaning Validation Technologies

Technical Consulting Services

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Cleaning Memos

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Monthly tidbits of useful information

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More on Floors and Walls

Cleaning Memo Archives

May 2008 More on Floors and Walls
Arpil 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 2005 

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

Destin A. LeBlanc

Cleaning Validation Technologies

1128 Eagle View Drive

Kodak, TN  37764

Phone:  865-932-6927

Fax:  865-932-6849

click here to contact Destin by email

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Web updated: 7?11?2005

 

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