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Cleaning
Memos: Volume 1 (October 2000 to December 2001)
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Date |
Title |
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October 2000 |
The Applicability of Cleaning Validation |
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November 2000 |
Campaigns and Dedicated Equipment |
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January 2001 |
Specificity of Analytical Methods |
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February 2001 |
Validation of Analytical Methods |
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March
2001 |
The New FDA
Compliance Program Guidance Manual and Cleaning
Validation |
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April 2001 |
Cleaning
for Manufacture of Clinical Trial Materials (CTMs) |
|
May 2001 |
Setting “Dose”
Limits without Dosing Information |
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June 2001 |
Water
Quality for Validated Cleaning Processes |
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July 2001 |
Product
Grouping Strategies for Cleaning Validation |
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August 2001 |
Equipment
Grouping Strategies for Cleaning Validation |
|
September 2001 |
Handling
Sampling Recovery Results |
|
October 2001 |
Dirty
Equipment Hold Times |
|
November 2001 |
Cleaned
Equipment Hold Time |
|
December 2001 |
What’s a “Dose” for Calculating Limits? |
|
|
Cleaning Memos: Volume 2
(January 2002 to
December 2002)
|
|
Date |
Title |
|
January 2002 |
The Use of Safety Factors in Limits Calculations |
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February 2002 |
The Use of Default Limits |
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March 2002 |
What’s a Contaminant? |
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April 2002 |
Understanding and Applying “Visually Clean” |
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May 2002 |
Cleaning Validation for Medical Devices |
|
June 2002 |
Recovery Studies for Microbial Sampling? |
|
July 2002 |
Worst-case Process Conditions |
|
August 2002 |
Selecting Swab Sampling Sites |
|
September 2002 |
Sampling the Sampling Rinse |
|
October 2002 |
Recovery Studies for Rinse Sampling |
|
November 2002 |
Additional Considerations in Recovery Studies Part
1 |
|
December 2002 |
Additional Considerations in Recovery Studies Part
2 |
|
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Cleaning
Memos: Volume 3 (January 2003 to December 2003)
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|
Date |
Title |
|
January 2003 |
More on DEHT Issues |
|
February 2003 |
Using Sampling Recovery Percentages |
|
March 2003 |
Is a Dirty Swab a “Visually Clean” Failure? |
|
April 2003 |
Using Statistics in Sampling? |
|
May 2003 |
What’s Really Different About Biotech? |
|
June 2003 |
Limits for Drugs with Multiple Actives |
|
July 2003 |
Adequate “Documented Evidence” for Cleaning
Validation |
|
August 2003 |
Why TOC is Acceptable |
|
September 2003 |
Correlation of Swab and Rinse Sample Results? |
|
October 2003 |
PAT and Cleaning Validation |
|
November 2003 |
Correlation of TOC with a Specific Analytical
Method? |
|
December 2003 |
Revalidation |
|
|
Cleaning
Memos: Volume 4 (January 2004 to December 2004)
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|
Date |
Title |
|
January 2004 |
Monitoring a Validated
Cleaning Process |
|
February 2004 |
Endotoxin Issues in
Cleaning Validation |
|
March 2004 |
Defining Three
“Consecutive” Runs |
|
April 2004 |
TOC Issues: Part 1 -
Sampling Materials |
|
May 2004 |
TOC Issues: Part 2 -
Appropriate Blanks |
|
June 2004 |
TOC Issues: Part 3 –
Blanks for Recovery Studies |
|
July 2004 |
Cleaning After a Media
Fill |
|
August 2004 |
More on Specificity of
Analytical Methods |
|
September 2004 |
Issues in the Visual
Examination of Equipment Surfaces |
|
October 2004 |
Selecting Worst-Case
Products for Grouping |
|
November 2004 |
Is Rinse Sampling Alone
Acceptable? |
|
December 2004 |
Establishing Adequate
Solubility for TOC Analysis |
|
|
Cleaning
Memos: Volume 5 (January 2005 to December 2005)
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|
Date |
Title |
|
January 2005 |
Understanding the Cleaning
Process |
|
February 2005 |
Dealing with Unknown Peaks |
|
March 2005 |
Cleaning Validation for
Packaging Equipment: Part 1 |
|
April 2005 |
Cleaning Validation for
Packaging Equipment: Part 2 |
|
May 2005 |
Objectionable Microorganism
Concept in Cleaning Validation |
|
June 2005 |
Setting Limits Based on
Process Capability? |
|
July 2005 |
Revisiting Cleaning
Validation for Medical Devices |
|
August 2005 |
Issues in Limits for
Formulated Cleaning Agents |
|
September 2005 |
More on Limits for Formulated
Cleaning Agents |
|
October 2005 |
Limits for Rinse “Grab”
Samples |
|
November 2005 |
Averaging Swab Sample
Results? |
|
December 2005 |
Selecting the Swab Sampling
Area |
|
|
Cleaning
Memos: Volume 6 (January 2006 to December 2006)
|
|
Date |
Title |
|
January 2006 |
Acceptance Criteria for
Dedicated Equipment |
|
February 2006 |
Bioburden Proliferation in
CEHT Protocols |
|
March 2006 |
Separating CEHT Protocols
from Cleaning Protocols |
|
April 2006 |
More on Using Rinse Sampling
Alone |
|
May 2006 |
Measuring Bioburden in
Protocols |
|
June 2006 |
Ion Mobility Spectrometry |
|
July 2006 |
FTIR with Fiberoptic Sampling |
|
August 2006 |
Surface Roughness and
Cleaning |
|
September 2006 |
CEHT for Sterilized Equipment |
|
October 2006 |
CV for General Room Surfaces? |
|
November 2006 |
Use of Sampling Templates |
|
December 2006 |
Dealing with Deviations in
the DEHT |
|
|
Cleaning
Memos: Volume 7 (January 2007 to December 2007)
|
|
Date |
Title |
|
January 2007 |
Dealing with Deviations in
the CEHT |
|
February 2007 |
Microbiological Test Method
Validation? |
|
March 2007 |
Limits for Bulk Biotech
Manufacture – Part 1 |
|
April 2007 |
Limits for Bulk Biotech
Manufacture – Part 2 |
|
May 2007 |
Revisiting Medically Safe
Limits |
|
June 2007 |
Issues in Campaigns |
|
July 2007 |
Spiking Amounts for Sampling
Recovery Studies |
|
August 2007 |
Master Plans vs. Policies |
|
September 2007 |
TOC Analytical Method
Validation |
|
October 2007 |
Downsides to TOC? |
|
November 2007 |
Measuring Residues of
Volatile Solvents? |
|
December 2007 |
More on Limits for API
Manufacture |
|
|
|
|
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