Biopharmaceutical raw material screening is a costly and time-consuming process that takes place in a laboratory setting. Samples must be taken from the production line and transferred to separate analytical facilities where raw material identification (RMID) is carried out via advanced analytical techniques.
Transferring material screening and quality control (QC) processes to the warehouse is key to improving workflows and reducing costly delays, which arise due to extensive sampling, and sample preparation that causes analysis bottlenecks. However, this requires an appropriately mobile instrument with all the capabilities of a benchtop QC analyzer to accelerate RMID processes, while still meeting current good manufacturing practice (cGMP) standards. Although Raman spectroscopy has long been used to address numerous processes in the pharmaceutical industry, including laboratory-based biopharmaceutical ingredients, handheld Raman instrumentation is able to transfer this testing directly to the warehouse.
Handheld Solutions: In-Field Biopharmaceuticals Screening
Few portable tools can match the ease-of-use of handheld devices when it comes to repetitive, time-consuming processes like biopharmaceutical screening. Handheld Raman spectrometers are much easier to implement in the field due to their compact design and high mobility. They are typically lightweight, ergonomic, and feature a long battery life to facilitate several hours of cordless, uninterrupted operation in pharmaceutical warehouses. These tools represent a significant increase in productivity, as time-consuming laboratory analysis can be readily transferred to the warehouse, allowing QC and RMID to be implemented directly at the point of receipt.
Raman is the preferred technique for RMID in biopharmaceutical screening. Major Pharmacopeias across the world now offer specific sections that assist with the application of Raman spectroscopy in pharmaceutical RMID. This ensures that onboarding processes are quick and painless to provide rapid returns on investment with appreciable improvements in quality control.
Biopharmaceutical Screening with Handheld Raman Solutions
As much as 95% of all raw materials in pharmaceutical and biopharmaceutical environments (APIs, excipients, inorganics, solvents, cell culture media, etc.) can be identified and characterized via handheld Raman spectroscopy with a 1064-nanometer (nm) laser due to reduced fluorescence, which can overwhelm Raman scattering with some samples. These Raman-active materials include: active pharmaceutical ingredients (APIs), antibiotics, antioxidants, buffers, cell culture media, coating agents, diluents, dyes, emulsifiers, excipients, lubricants, proteins, preservatives, serums, solvents, vitamins, and more. Handheld Raman spectroscopy can even be used to verify pharmaceutical packaging materials such as different types of plastics. The NanoRam-1064 from B&W Tek excels in this area, facilitating quick and easy identification of the broadest possible range of raw materials in pharmaceutical warehouse settings.
This ensures that no critical ingredients are neglected from robust quality control processes.
B&W Tek: Solutions for Biopharmaceutical Screening
B&W Tek specializes in the development of unique analytical solutions that meet industry-specific demands and requirements. Our tried-and-tested Nano-Ram 1064 combines the high analytical capabilities of Raman spectroscopy with a suite of practical features to improve usability in warehouse settings. It is compatible with typical bulk pharmaceutical packaging; able to read through the clear internal packaging of raw material drums, to acquire an accurate Raman spectrum of the raw material for the purposes of identification and verification.
If you would like to learn more about using B&W Tek solutions for biopharmaceutical applications, simply contact a member of the team today.