Developing an instrument for characterizing pharmaceutical materials, to bring safe medications to patients

Developing an instrument for characterizing pharmaceutical materials, to bring safe medications to patients

Ocean Insight and Malvern Panalytical collaborated to engineer a particle analyzer powerful enough to help customers better understand and utilize materials, yet flexible enough for a diverse array of industries.

CHALLENGE

With better understanding of the materials that supply their businesses, manufacturers can enhance product performance, improve process efficiencies and offer better value to customers. Access to precise analytical tools provides pivotal insight into the chemical, physical and structural properties of materials.

For example, in the pharmaceuticals industry, determining critical material characteristics in drug ingredients allows better control of formulation and processing. Also, validating active pharmaceutical ingredients (the biological components of drugs) is necessary to ensure that formulations match the original drug as patents expire, or can be used to develop generics that are still safe but don’t entail the typical clinical testing costs required with new (innovator) drugs.

INSIGHT

Malvern is an industry leader in scientific instrumentation that characterizes the length, width and shape of particles in samples ranging from building materials to pharmaceuticals. In recent years, particle analyzers have been enhanced by adding on Raman spectroscopy, which provides chemical identification capabilities. This adds another level of material analysis previously unavailable.

Ocean Insight was confident in providing for Malvern a smaller, more flexible alternative to its previous Raman system, which was large, unwieldy and not fully integrated with the Malvern Morphologi-brand particle analyzer. This also represented an opportunity to improve the Raman system performance, as Ocean’s approach is more flexible and easily optimized.

SOLUTION

Ocean Insight worked closely with Malvern to define the technical scope of the project. By drawing on their shared expertise in applications, optics, software, testing and commercialization, Ocean Insight overcame the technical challenges of integrating a Raman subsystem with the particle analyzer into a single platform. This involved developing an optical design capable of making maximum use of laser light, optical pathways and calibration procedures, as Raman can be a challenging technique to master.

Each component of the subsystem – spectrometer, laser, optics and software — was designed, selected and assembled in synergy with Malvern to optimize the result. Ocean Insight and Malvern Panalytical remain engaged as the project further evolves, aligning service, support and supply chains to meet future needs.

Flexibility within the system design will allow Ocean and Malvern to adapt the system to changing industry needs, from creating better-performing building materials like cement to extracting more meaningful information from geological deposits to predict future environmental conditions.

Original article published: https://www.oceaninsight.com/solutions/case-studies/pharma-drug-characterization?utm_content=207248258&utm_medium=social&utm_source=facebook&hss_channel=fbp-83172388812