2007 NSTI Nanotechnology Conference and Trade Show - Nanotech 2007 - 10th Annual

Cleaning verification and drug purity within the Pharmaceutical manufacturing process

D.K. Corrigan S. Piletsky S. McCrossen
Cranfield University, UK

Keywords:
Cleaning Verification, SERS, alkylating agents, fluoresencence spectoroscopy

Abstract:
The principle aims of this project are to investigate two aspects of the pharmaceutical production process of particular importance within multipurpose pharmaceutical manufacturing facilities. Cleaning verification is the process by which the plant is precisely determined as sufficiently free of the previously manufactured compound so that production of the next product can commence. The equipment involved must be analysed and proven to be below the acceptable residue limits. The pharmaceutical industry currently employs HPLC as the technique for analysis of samples. The process is costly and due to the large number of samples involved results in large periods of Cleaning verification is the process by which the plant is precisely determined as sufficiently free of the previously manufactured compound so that production of the next product can commence. The equipment involved must be analysed and proven to be below the acceptable residue limits. The pharmaceutical industry currently employs HPLC as the predominant technique for analysis of samples. The process is costly with lengthy periods of manufacturing downtime resulting from the large number of samples that require analysis and the associated preparatory work. Cleaning verification represents a significant cost factor and significant drug safety problem to the industry. One of the focuses of this project has been an attempt to develop an alternative to HPLC that has the equivalent levels of sensitivity and specificity but reduces the time of analysis. One approach we have looked at is Surface Enhanced Raman Spectroscopy (SERS). We have evaluated the sensitivity of the technique and found it to be appropriate for use in the project. Samples for cleaning verification analysis are collected from manufacturing equipment by swabbing. Normally the compound of interest is extracted from the swab in solvent and subjected to HPLC analysis. Our approach has been to try and detect contamination directly from the swab with this spectroscopic method and with the aim of implementing the technique industrially we have looked at the use of gold colloid, gold impregnated swabs and gold nanostructures to achieve the necessary enhancement of signal. If successful, cleaning verification work will be less labour and reagent intensive and therefore more cost efficient to the industry as a whole.

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