The use of a handheld Raman analyser for the positive identification of raw materials in a manufacturing pharmaceutical company was evaluated using paracetamol as test raw material to evaluate whether such a system would meet Aspen’s regulatory requirements. The approach involved subjecting the chosen raw material to identification tests under a variety of conditions so as to evaluate robustness, and specificity of the system. Thus, raw material provided by different suppliers, different packages of one manufacturing batch, and raw materials subjected to different storage conditions were evaluated. Specificity was evaluated by deliberately contaminating a sample of paracetamol with either acetanilide, or 4-aminophenol, or both at varying concentration levels. The results obtained from these investigations showed that the handheld Raman analyser can correctly identify the selected raw material (paracetamol) under a wide range of conditions, but could not correctly identify the presence of the selected contaminants at lower concentration levels (< 10 – 20 mass percent). Finally, a cost-benefit analysis was carried out in which a scenario of an existing FTIR-ATR system is used for the analysis of a specific number of raw material samples per year as opposed to a scenario in which a new handheld Raman analyser has to be purchased, set up, and used for the analysis of the same number of raw material samples. This comparison showed that the handheld Raman analyser had a pay-back time of approximately 6 months and gave a return on investment of approximately the same value as the actual purchase cost.
| Identifer | oai:union.ndltd.org:netd.ac.za/oai:union.ndltd.org:nmmu/vital:20570 |
| Date | January 2015 |
| Creators | Mavumengwana, Bongeka Nomakhephu |
| Publisher | Nelson Mandela Metropolitan University, Faculty of Science |
| Source Sets | South African National ETD Portal |
| Language | English |
| Detected Language | English |
| Type | Thesis, Masters, MTech |
| Format | 48 leaves, pdf |
| Rights | Nelson Mandela Metropolitan University |
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