Articles by Richard J. Forsyth - Pharmaceutical Technology

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Articles by Richard J. Forsyth

Richard J. Forsyth

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688,

Understanding the Cleaning Validation Lifecycle
April 16, 2014

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

Qualifying Personnel to Visually Inspect Cleaned Equipment
January 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
October 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)
March 2, 2011

The author challenges current detection methodologies.

Do Visible Residue Limits Make the 10-ppm Carryover Limit Obsolete?
February 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
March 2, 2009

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

Equipment Hold-Time for Cleaning Validation
April 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
October 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
January 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.


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