A device for cleaning validation in pharmaceutical manufacturing - 1265
- *Abstract
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Overview
In recent years, the issue of cleaning validation in pharmaceuticalmanufacturing processes has grown significantly, and many companies have had torealign their manufacturing capabilities to meet the more stringentrequirements set by regulatory agencies. The purpose of cleaning validation isto verify that potentially harmful compounds have been removed fromsurfaces in process equipment prior to use for another purpose. Traditionalmethods for cleaning validation include the collection of sample residues viaswabbing or rinse matrices, followed by quantitative analysis of the collectedsamples. Swab residue analysis is labor intensive, inefficient in recovery,dependent on facility shutdown, and time consuming. Rinse matrix analysisrequires a more sophisticated analysis, is vulnerable to dilution errors, and comprisesanalyte integrity.
Invention
UK researchers are developing an automated spectralanalyzer for the detection and characterization of biofilms and other surfacecontaminants. In contrast to currently available cleaning validation methods,this device utilizes a diode laser system to rapidly identify the presence orabsence of an analyte of interest. The device has no focusing optics, so it is rugged and dependable and suitable for use on robots and drones. In addition to its superior speed, thedevice is capable of performing a multi-component analysis of the scan. Thisinvention is an inexpensive, verifiable method for validating adequate cleaningof pharmaceutical process equipment and process lines, significantly promotingthe economic viability of using equipment for multiple products.
Applications
- pharmaceutical manufacturing
- robotics and drones
Advantages
- may provide a spectroscopic, in situ automated system for rapiddetermination of surface contamination
- detects a variety of components
- reduces cost for surface contaminationdetection methods
- less downtime of involved equipment processes
IP Status: U.S. Patent No. 7,557,923
- 國家/地區
- 美國
