March 2, 2006
By:Kaylynn Chiarello-Ebner
Pharmaceutical Technology
Analytical tools and methods that require less water and detergent are gaining interest for faster, more efficient cleaning.
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October 2, 2005
By:Richard J. Forsyth, Vincent Van Nostrand
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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October 2, 2005
By:Richard J. Forsyth, Vincent Van Nostrand
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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April 2, 2005
By:Scott Sutton
Pharmaceutical Technology
The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results.To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the pparent number in the sample.
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April 2, 2005
By:Evelyn F. Der
Pharmaceutical Technology
A comparative study of three air samplers used for bioaerosol collection was performed to evaluate the average recovery of colony-forming units and assess the precision of each device.
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April 2, 2005
By:Richard J. Forsyth
Pharmaceutical Technology
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.
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April 1, 2005
By:Scott Sutton
The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the apparent number in the sample.
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April 1, 2005
By:Evelyn F. Der, Joe P. Stablein, Daniel A. Coleman, PhD
A comparative study of three air samplers used for bioaerosol collection was performed to evaluate the average recovery of colony-forming units and to assess the precision of each device.
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October 2, 2004
By:Richard J. Forsyth, Vincent Van Nostrand, Gregory P. Martin
Pharmaceutical Technology
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.
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