Articles by Richard J. Forsyth - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

  • Search
  • Suppliers
  • Careers

Enter a company or product name

Keyword Location
About Search
Articles by Richard J. Forsyth

A Single Adulteration Limit for Cleaning Validation in a Pharmaceutical Pilot-Plant Environment

Jan 2, 2007

An adulteration limit of 100 ?g/25cm? (4 ?g/cm?) was proposed for pilot-plant facilities. The dynamic changes in equipment, formulation, and residue determination made implementation of a constantly changing, calculated adulteration limit impractical. A single adulteration limit was simpler to communicate and document, making compliance achievable. The limit would be used only after it was determined to be lower than a health-based evaluation and a visual-cleanliness assessment.

Correlation of Visible-Residue Limits with Swab Results for Cleaning Validation

Nov 2, 2006

The correlation between swab assay results and visible-residue limits (VRLs) for cleaning validation was examined. Previously completed validation studies were reviewed to compare swab results with recently determined VRLs. A current cleaning validation study evaluated both swab testing and VRL. Unexpected swab results led to an investigation, which showed the value of establishing the VRL in conjunction with swab recoveries for cleaning validation programs.

Risk-Management Assessment of Visible-Residue Limits in Cleaning Validation

A risk-management assessment of visible-residue limits (VRL) in cleaning validation of pharmaceutical formulations was conducted for both pharmaceutical pilot plant and manufacturing facilities. The authors discuss how potential risks were identified, analyzed for probability, considered for seriousness, and controlled through avoidance or mitigation. These opportunities for VRL implementation then were identified for both pilot plant and manufacturing settings.
Sep 2, 2006

Before formal cleaning validation programs were instituted, visual inspection was the primary means of determining equipment cleanliness. The use of visual inspection is still typically a component of a cleaning validation program and for routine inspections of cleaning effectiveness, but the use of visual inspection as a sole criterion for equipment cleanliness has not been successfully implemented as a valid approach for cleaning validation.

Application of Visible-Residue Limit for Cleaning Validation

Oct 2, 2005

Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.

Application of Visible-Residue Limit for Cleaning Validation Richard J. Forsyth and Vincent Van Nostrand

Oct 2, 2005

Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.

Using Visible Residue Limits for

Apr 2, 2005

An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.

Visible-Residue Limit for Cleaning Validation and its Potential Application in Pharmaceutical Research Facility

Oct 2, 2004

Evaluations have shown, in most cases, visual observations are sensitive enough to verify equipment cleanliness. An experiment was conducted to explore the possibility of using a visible-residue limit as an acceptable cleaning limit in a pharmaceutical research facility, including an evaluation of the limits and subjectivity of ?visually clean? equipment.

ADVERTISEMENT

LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
FindPharma Custom Search
Click here