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Cleaning

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

September 2, 2006

Pharmaceutical Technology

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.

Importance of Clean-in-Place Design Planning Emphasized

April 25, 2007

INTERPHEX Show Daily

Interphex2007, New York, NY (Apr. 25)-As manufacturers prepare for processing more-potent compounds, they seek effective clean-in-place (CIP) and wash-in-place (WIP) design systems.

What is Disinfectant Validation?

March 2, 2006

Pharmaceutical Technology

Adding a cleaning step to the field-testing protocol, and combining it with the data generated to register sanitizing and disinfectant agents under FIFRA and the CEN TC 216 work program, produces a sanitation-and-disinfection validation methodology that is cost-effective, simple, and time-saving.

Pursuing Efficiency: New Developments in Cleaning Technology

March 2, 2006

Pharmaceutical Technology

Analytical tools and methods that require less water and detergent are gaining interest for faster, more efficient cleaning.

Application of Visible-Residue Limit for Cleaning Validation

October 2, 2005

Pharmaceutical Technology

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

October 2, 2005

Pharmaceutical Technology

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.

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