The role of visual examination as the sole acceptance criterion in cleaning validation
protocols is explored, including the proper definition of “visual limit” for a given residue. Such …

The standard of visual cleanliness is commonly applied to the evaluation of surface
contamination. Numerous published studies have examined the visually clean standard as a …

Part I of this article reviews the history of Cleaning Validation Acceptance Limits for Active
Pharmaceutical Ingredients (APIs) and identifies the origins of currently used industry limits …

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation
to minimize cross contamination into next product has been employed for many years. This …

Visual inspection is always a component of a cleaning-validation program, and routine
visual inspections for equipment cleanliness are a crucial part of day-to-day operations in a …

Validation Of Visual Inspection As An Analytical Method For Cleaning Validation Page 1
Validation Of Visual Inspection As An Analytical Method For Cleaning Validation By Parth Desai …

An industry workgroup comprised of toxicologists and manufacturing equipment cleaning
subject matter experts was formed to examine the European Medicines Agency (EMA) …

Background The method widely used within the pharmaceutical industry for setting residual
acceptance levels is the one provided by Fourman and Mullen, whose paper is listed in the …

The correlation between swab assay results and visible-residue limits (VRLs) for cleaning
validation was examined. Previously completed validation studies were reviewed to …

The cleaning processes used in pharmaceutical operations have achieved an increasing
emphasis in the past decade both by the regulatory agencies and industry itself. At this time …