Portable Raman for Raw Material QC: What’s the ROI?

The plan assumes the number of samples will remain constant over the 3 years. However, the reduction of samples analyzed by the central laboratory will have a direct impact on the cost per analysis, as the number of samples required to be sent from the warehouse to the central laboratory was estimated to decrease by 85%. It is also worth pointing out that as the number of samples analyzed in the lab changes by 50% in the first year, a reallocation of manpower and some instrument consumables is required, which, in this scenario, is covered by the validation costs.

The phasing in of the warehouse testing over three years, using the two Raman units, is outlined in Table 5, while the total cost per sample in Year 3 is shown in Table 6. The average savings associated with changing to warehouse testing were in the region of $150,000, based on the difference between the reduction of laboratory operational costs, consumables and other factors (~ $250,000), less the initial investment of the two hand-held Raman spectrometers and associated validation procedures, which was estimated to be about $100,000.

Cost of Investing in Additional Central Laboratory Capabilities to Handle Increased Workload
We now examine the cost of investing in additional central laboratory capabilities to handle the increased testing from 22,500 samples to 112,500 samples per year. Based on the company scenarios described earlier, the cost for the expansion of the existing analytical capabilities was calculated to require an increase in laboratory manpower of one full-time and one part-time (50%) technician for the sample preparation and sample handling in the warehouse. Other costs associated with holding the raw materials in the quarantine area for longer times and the extra space required for them, were calculated to be in the order of 30% of the overall cost. Additionally, the use of existing laboratory instrumentation, repairs and sample handling consumables was estimated to be approximately 250% higher than the current expenditure.

For these companies, the extra costs represented an average of approximately $300,000 per year to the operational budget. When the existing central laboratory operational/maintenance costs per year of $417,500 are factored into the calculation, this translates to a total cost per sample of $6.34, based on the increased number of samples from 22,500 to 112,500. However, this amount is significantly lower than the initial cost of $17.78, when only 20% of the samples were tested. A cost comparison of these two lab-based testing scenarios with the handheld Raman warehouse solution is summarized in Table 7.

Although each facility faces unique challenges, this comparison suggests that handheld Raman testing in the warehouse offers pharmaceutical manufacturers a powerful tool to help increase efficiencies and reduce the cost of raw material QC.

References
1. An implementation Perspective on Handheld Raman Spectrometers for the Verification of Material Identity: B. Diehl, C.S. Chen, B. Grout, J. Hernandez, S. O’Neill, C. McSweeney, J. M. Alvarado and M. Smith, Pfizer Inc; European Pharmaceutical Review, Non-destructive Materials Identification Supplement, Volume 17, Issue 5, 2012, http://www.europeanpharmaceuticalreview.com/wp-content/uploads/Raman-Supplement-2012.pdf
2. Portable Raman Spectroscopy for Pharmaceutical Counterfeit Detection: R. Kalyanaraman, M. Ribick and G. Dobler, Bristol-Myers Squibb; European Pharmaceutical Review, Non-destructive Materials Identification Supplement, Volume 17, Issue 5, 2012, http://www.europeanpharmaceuticalreview.com/wp-content/uploads/Raman-Supplement-2012.pdf
3. Fake Pharmaceuticals: Bad Medicine, The Economist, October 13, 2012, http://www.economist.com/node/21564546
4. The NanoRam hand-held Raman Spectrometer: B&W Tek Application Note, http://bwtek.com/products/nanoram/
5. NanoRam: Full Regulatory Compliance for the Inspection of Raw Materials & Chemicals in the Pharmaceutical Industry: B&W Tek Application Note, http://bwtek.com/learning-lab/application-notes/
6. The NanoRam Hand-held Raman Spectrometer: Ideally-suited for the Inspection of Raw Materials and Chemicals Used in the Pharmaceutical industry: B&W Tek Application Note, http://bwtek.com/learning-lab/application-notes/
7. Statistical Solutions: Square Root of (N) + 1 Sampling Plan: L. D. Torbeck, Modern Medicine, Oct 2, 2009; http://www.modernmedicine.com/modernmedicine/article/articleDetail.jsp?id=631722