Cleaning Memos

Cleaning Memo Archives
	Destin A. LeBlanc Cleaning Validation Technologies Technical Consulting Services
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Home	Monthly tidbits of useful information
Current Month	More on Floors and Walls
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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