More on Limits Based on Compendial Water Values
The 500 ppb TOC Myth
Using Safety Factors of Less than 0.001 of a Dose
Does Risk-MaPP Offer More Patient Protection?
Recovery Studies for Different Surfaces for Rinse Sampling
Grouping for Surfaces for Swab Recovery Studies?
Selecting the Number of Validation Runs for Equipment Grouping
Another Critique of Risk-MaPP
Revisiting Limits Based on Process Capability
My Revised Shorthand for Expressing Limits
Differences between Cleaning and Process Validation
Significance of Water Activity for Cleaning Validation
Regulatory Guidances I’d Like to See Changed – Part 2
Regulatory Guidances I’d Like to See Changed – Part 1
How to Completely Avoid Doing Cleaning Validation
How Are ADE’s Determined for Non-Highly Hazardous Actives?
Hold Time Issues
Issues in Cleaning Validation for Parts Washers
The Good, the Bad and the Inexplicable of Risk-MaPP
Limits Below the LOD in Rinse Solutions – Part III
Limits Below the LOD in Rinse Solutions – Part II
Limits Below the LOD in Rinse Solutions – Part I
More on an Alternative Swab Recovery Procedure
Manual Cleaning Issues – Part 2
Where Risk-MaPP Got It Wrong
Manual Cleaning Issues – Part 1
An Alternative Swab Recovery Procedure
A Conundrum Regarding Limits
What Does the FDA Process Validation Guidance Say about the Number of Qualification Runs
More on ISPE’s RiskMaPP
More on Campaign Length
Understanding the Cleaning Process in 2010 (and Beyond)
A Critique of Cleaning Validation Issues in ISPE’s RiskMaPP
Swab Sampling Recovery as a Function of Residue Level
More Uses for Visual Limit Determination
Visually Clean and Visual Limits
Statistics for Visual Limits
Acceptable Variability for Sampling Recovery Studies
Final Notes on “Stratified Sampling”
More on “Stratified Sampling”
Basics of “Stratified Sampling”
Revisiting “Cleaning Verification”
What’s an “Equivalent” Swab?
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
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
Campaigns and Dedicated Equipment
The Applicability of Cleaning Validation
Human Drug CGMP
2nd Quarter 2001
1st Quarter 2002
Coupons for Recovery Studies
Flexible Fiberoptic Scopes
High Pressure Equipment Cleaning Systems
In-line UV for Cleaning Monitoring
Microbial Identification Labs
Tank or Bin Liners
Ultrasonics: Consoles for Parts Washing
Ultrasonics: Immersible Transducers for Tank Cleaning
Vials for TOC sampling
Cleaning Memo pdf
Purchase Cleaning Memos
Credit Card Purchase
May Cleaning Memo
- More on Limits Based on Compendial Water Values
Good Cleaning Validation Practices
- September 19-20, 2013, St. Louis, MO
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For my written concerns with ISPE’s RiskMaPP,
see the web site
FDA Drug School Presentation
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