Articles by Richard J. Forsyth - Pharmaceutical Technology

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Articles by Richard J. Forsyth

Cleanability of Pharmaceutical Soils from Different Materials of Construction

The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.
Jul 2, 2014

The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.

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.

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