Visual inspection is widely used in sanitation program monitoring. However, the degree of
residual food soil on equipment surfaces that is below the limit of visual detection has not …

An increasing number of new compounds are being introduced into pharmaceutical pilot
plants. The knowledge base for these compounds regarding their toxicities, physical …

Compounding pharmacies have been cited by some athletes as being responsible for
compounding capsules contaminated with drugs banned by the International Olympic …

This study uses on‐line absorbance monitoring to evaluate cleanability of protein drug
products. Characterization and validation of equipment cleanliness is a key requirement for …

Laboratory studies are an important part of a cleaning validation program. Studies discussed
are those in addition to typical laboratory quantitative analysis of swab or rinse samples." …

A method of validating or verifying a process for cleaning a surface contaminated with at
least one chemical substrate, comprising the steps of: capturing an infrared image of the …

This study reports the results of a designed experiment to evaluate the use of the o-phthalic
dialdehyde (OPA) method for residual protein, with a test soil derived from blood …

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

Cleaning validation, in which cleaned surfaces are analysed for residual material, is an
important process in pharmaceutical manufacturing and research facilities. Current …

In accordance with the 2011 FDA guidance for industry, Process Validation General
Principles and Practices, there is a requirement to continue to verify equipment cleaning …