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

Understanding the Cleaning Validation Lifecycle

Considering cleaning validation as a complete lifecycle is crucial for maintaining an effective program. Richard Forsyth offers the following tips based on his presentation at INTERPHEX 2014.
Apr 16, 2014

The cleaning validation lifecycle includes assessment, development, validation, and monitoring.

Qualifying Personnel to Visually Inspect Cleaned Equipment

The author discusses several different approaches for qualifying personnel for visual inspection.
Jan 2, 2014

Different approaches for qualification of personnel for visual inspection of residues on equipment surfaces are reviewed.

Ruggedness of Visible Residue Limits for Cleaning-Part III: Visible Residue Limits for Different Materials of Construction

Risk of a cleaning failure due to visual failure for different materials of construction can be mitigated or eliminated using complementary cleaning validation studies.
Oct 2, 2013

The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.

Ruggedness of Visible-Residue Limits for Cleaning (Part II)

The author challenges current detection methodologies.
Mar 2, 2011

The author challenges current detection methodologies.

Do Visible Residue Limits Make the 10-ppm Carryover Limit Obsolete?

The author discusses how the use of a visible residue limit has made the 10-ppm cleaning limit obsolete in many applications.
Feb 2, 2010

The author discusses how the use of a visible residue limit has made the 10-ppm cleaning limit obsolete in many applications.

Ruggedness of Visible Residue Limits for Cleaning Validation

The author tests the ruggedness of VRL viewing conditions and defines optimal viewing conditions.
Mar 2, 2009

The author tests the ruggedness of VRL viewing conditions and defines optimal viewing conditions.

Equipment Hold-Time for Cleaning Validation

Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.
Apr 2, 2008

Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.

Materials of Construction Based on Recovery Data for Cleaning Validation

The material of construction is a factor in the recovery of residue in cleaning validation. An analysis of existing recovery data showed that recovery factors for drug products on various materials of construction may be categorized into several groupings.
Oct 2, 2007

The material of construction is a factor in the recovery of residue in cleaning validation. An analysis of existing recovery data showed that recovery factors for drug products on various materials of construction may be categorized into several groupings.

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.

ADVERTISEMENT

LCGC E-mail Newsletters

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

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
25%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
11%
Regulatory compliance
36%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
FindPharma Custom Search
Click here