SPONSORED: SPECTROSCOPY
Increasing yields and recovering scrap materials in pharmaceuticals
I
n the pharmaceutical industry, issues related to full reagent use and
rigorous cleaning validation are often linked to additional production costs and decreased yield. Yet carefully considered implementation of spectroscopy solutions into existing processes can help. Indeed, with spectroscopy-based monitoring systems, manufacturers and contract development and manufacturing organisations (CDMOs) can streamline process efficiency, reduce waste and improve operational compliance.
The challenges: recovery, waste, and compliance CDMOs typically face one or more common processing challenges related to recovery, waste, and compliance: • Reagent recovery: If chemical reactions are not complete before production ends, reagents may be lost. Stopping the process early may produce a portion of the intended result, but the chemicals left behind are often unrecoverable and become waste.
• Cleaning-related waste: To avoid cross-contamination when switching production of one drug to another, many organisations opt for over- cleaning methods to ensure run-off doesn’t contain unexpected reagents. Over- cleaning reduces risk but takes longer to perform and requires more resources.
• Chemical disposal compliance: Regulatory bodies have codified policies on the handling and disposal of pharmaceuticals for manufacturers, healthcare agencies, and end-users. For disposal processes to be effective, drug makers need to know precisely what chemicals – and in what concentrations – are found in their production waste.
18 Electro Optics May 2023
The solution: situation- specific spectroscopy Purpose-built spectrometers can help companies reduce reagent loss, minimise waste, and improve disposal compliance. Consider production line
reactions: by integrating spectrometers into processes, companies can accurately determine reagent amounts and better manage reaction processes. For example, a Raman spectrometer can be used to measure the vibrational energy of molecules in products and solutions in real time to determine if reactions are fully complete. For cleaning validation,
both absorption through flow cells and analysis with Raman spectrometers offer a way to ensure that chemical concentrations in vat run-off have decreased enough that new production runs can begin. Many vats are fully clean after 24 hours, but companies may run them for 72 hours or more as a way to ensure complete cleanliness. With spectral monitoring employed, cleaning can be accomplished more quickly and with a need for less cleaning solvent.
The benefits: doing more with less Given the time and investment required to develop new drugs,
pharmaceutical companies are always seeking new ways to better manage production processes. By using precise and reliable spectroscopy to ensure reactions are complete and cleaning validation is comprehensive without being wasteful, pharmaceutical producers are better prepared to deliver a sustainable return on investment.
Streamlined processes Even minor changes in production line processes can result in wasted reagents or contaminated processes. Purpose-built spectrometers can detect tiny fluctuations in chemical composition, making it possible to pinpoint potential problem areas quickly. This also applies to cleaning
processes. Rather than relying on staff to ensure that vats are cleaned for a pre-selected amount of time for validation, the use of inline absorption or Raman analysis allows companies to easily check current runoff levels. Inline, real-time analysis of chemical reagent reactions allows organisations to incorporate product evaluation as part of standard operating procedures. In practice, this removes the need for product samples to be captured and sent to onsite or third-party labs for analysis.
Operational innovation There’s also a case to be made for spectrometers as a catalyst for operational innovation. Consider a pharmaceutical company running test batches of a new product. Inline spectroscopy can help identify areas for process improvement based on how well reagents combine and how long the process takes. When it comes to waste, custom-built spectrometers can a) ensure that waste product concentrations adhere to regulatory expectations, and b) identify waste materials that fall under the threshold for active pharmaceutical ingredient- containing hazardous waste disposal.
The results: increased yields, better savings, and reduced waste By implementing inline or at-line spectroscopy solutions from Ocean Optics, pharmaceutical firms and CDMOs are better equipped to monitor ongoing chemical reactions and ensure completion, recover unused reagent portions, and streamline cleaning validation processes. The result is an operational
trifecta that allows organisations to improve product yields, increase scrap savings, and reduce total waste. Spectral systems also provide more accurate insight into chemical disposal compositions and the actions required to ensure regulatory compliance. Advanced, accurate, and agile
spectroscopy is a clean sweep for pharmaceutical companies looking to maximise revenue and minimise waste in a rapidly expanding market. EO
Further information For more information about spectroscopy solutions from Ocean Optics, an Ocean Insight brand visit:
www.oceaninsight.com/ pharma-EOMay23
@electrooptics |
www.electrooptics.com
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