Services
Qualifications
Cleaning Memos
Resources
Store
Contact Me
Home
Client Services
On-Site Training
Seminars
Webinars
Speaking Engagements
Client List
Basic Concepts
Validation Practices
Design and Development of Cleaning Processes
Recorded Webinars
Curriculum Vitae
Publications
Presentations
Ethics Statement
FAQs
2010
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
What’s an “Equivalent” Swab?
Revisiting “Cleaning Verification”
Basics of “Stratified Sampling”
More on “Stratified Sampling”
Final Notes on “Stratified Sampling”
Acceptable Variability for Sampling Recovery Studies
Statistics for Visual Limits
Visually Clean and Visual Limits
More Uses for Visual Limit Determination
The Rationale for Rinse Sampling for Cleaning Agents
“Continued” vs. “Continuous” Process Verification
Use of Multiple Swabs for Sampling
“Design Space” for Cleaning Processes
The Changing Paradigm for Cleaning Validations
Revisiting Linearity of Swab Recovery Results
Use of Alkali/Acid Cleaning Agents in Biotech
The Science Behind Limits
What’s Happening to Worst-case Process Conditions?
Differing Ways to Express Limits
Another Alternative for Rinse Sampling Limits
Limits for Rinse “Grab” Samples
Solvent Reflux Sampling Recovery
Limits for Topicals
Are We Setting Limits Correctly?
Sampling Recovery for Biotech
Do Three Verifications Make a Validation?
What’s Happening to Revalidation?
Still More on Floors and Walls
More on Floors and Walls
What Have We Learned in the Last Two Decades?
Canada’s Revised Guidelines
A Stroll Down Memory Lane
Can Protocols Use Limit Tests?
More on Limits for API Manufacture
Measuring Residues of Volatile Solvents?
Downsides to TOC?
TOC Analytical Method Validation
Master Plans vs. Policies
Spiking Amounts for Sampling Recovery Studies
Issues in Campaigns
Revisiting Medically Safe Limits
Limits for Bulk Biotech Manufacture – Part 2
Limits for Bulk Biotech Manufacture – Part 1
Microbiological Test Method Validation?
Dealing with Deviations in the CEHT
Dealing with Deviations in the DEHT
Use of Sampling Templates
CV for General Room Surfaces?
CEHT for Sterilized Equipment
Surface Roughness and Cleaning
FTIR with Fiberoptic Sampling
Ion Mobility Spectrometry
Measuring Bioburden in Protocols
More on Using Rinse Sampling Alone
Separating CEHT Protocols from Cleaning Protocols
Bioburden Proliferation in CEHT Protocols
Acceptance Criteria for Dedicated Equipment
Selecting the Swab Sampling Area
Averaging Swab Sample Results?
Limits for Rinse “Grab” Samples
More on Limits for Formulated Cleaning Agents
Issues in Limits for Formulated Cleaning Agents
Revisiting Cleaning Validation for Medical Devices
Setting Limits Based on Process Capability?
Objectionable Microorganism Concept in Cleaning Validation
Cleaning Validation for Packaging Equipment: Part 2
Cleaning Validation for Packaging Equipment: Part 1
Dealing with Unknown Peaks
Understanding the Cleaning Process
Establishing Adequate Solubility for TOC Analysis
Is Rinse Sampling Alone Acceptable?
Selecting Worst-Case Products for Grouping
Issues in the Visual Examination of Equipment Surfaces
More on Specificity of Analytical Methods
Cleaning After a Media Fill
TOC Issues: Part 3 – Blanks for Recovery Studies
TOC Issues: Part 2 - Appropriate Blanks
TOC Issues: Part 1 - Sampling Materials
Defining Three “Consecutive” Runs
Endotoxin Issues in Cleaning Validation
Monitoring a Validated Cleaning Process
Revalidation
Correlation of TOC with a Specific Analytical Method?
PAT and Cleaning Validation
Correlation of Swab and Rinse Sample Results?
Why TOC is Acceptable
Adequate “Documented Evidence” for Cleaning Validation
Limits for Drugs with Multiple Actives
What’s Really Different About Biotech?
Using Statistics in Sampling?
Is a Dirty Swab a “Visually Clean” Failure?
Using Sampling Recovery Percentages
More on DEHT Issues
Additional Considerations in Recovery Studies Part 2
Additional Considerations in Recovery Studies Part 1
Recovery Studies for Rinse Sampling
Sampling the Sampling Rinse
Selecting Swab Sampling Sites
Worst-case Process Conditions
Recovery Studies for Microbial Sampling?
Cleaning Validation for Medical Devices
Understanding and Applying “Visually Clean”
What’s a Contaminant?
The Use of Default Limits
The Use of Safety Factors in Limits Calculations
What’s a “Dose” for Calculating Limits?
Cleaned Equipment Hold Time
Dirty Equipment Hold Times
Handling Sampling Recovery Results
Equipment Grouping Strategies for Cleaning Validation
Product Grouping Strategies for Cleaning Validation
Water Quality for Validated Cleaning Processes
Setting “Dose” Limits without Dosing Information
Cleaning for Manufacture of Clinical Trial Materials (CTMs)
The New FDA Compliance Program Guidance Manual and Cleaning Validation
Validation of Analytical Methods
Specificity of Analytical Methods
Happy Holidays
Campaigns and Dedicated Equipment
The Applicability of Cleaning Validation
Specific Documents
Human Drug CGMP
Site Links
Supplier Sites
Glossary
Acronyms
Jobs
June 1995
September 1995
September 1997
March 1998
June 1998
December 1998
March 1999
September 1999
March 2000
September 2000
2nd Quarter 2001
1st Quarter 2002
Cleaning Agents
CIP Equipment
Coupons for Recovery Studies
Flexible Fiberoptic Scopes
High Pressure Equipment Cleaning Systems
In-line UV for Cleaning Monitoring
Sampling Swabs
Sampling Accessories
Spray Devices
Tank or Bin Liners
TOC Instruments
Ultrasonics: Consoles for Parts Washing
Ultrasonics: Immersible Transducers for Tank Cleaning
Vials for TOC sampling
A-B
C
D
E-H
I-K
L-O
P-Q
R
S
T-V
W-Z
Cleaning Memo pdf
Training Material
Residue Software
Recorded Webinars
Purchase Cleaning Memos
Description
Evaluation Copy
Credit Card Purchase
List of Recorded Webinars
Purchase Recorded CDs
System Requirements
Seminars sponsored by Cleaning Validation Technologies:
None at this time.
Other seminars in which Mr. LeBlanc is the sole speaker:
None at this time.
Other speaking engagements by Mr. LeBlanc:
None at this time.