Where Has Low Cost Handheld Raman Spectrometer For Pharmaceuticals Quality Assurance?

Handheld Raman Instruments

In the pharmaceutical industry, the advent of portable and handheld Raman equipments has enabled new analytical capabilities for production traceability, quality control and quality assurance. Nowadays, Optosky can be equipped with a variety of analytical techniques such as Mid-infrared, Near infrared, and UV & Visible capabilities.

These handheld instruments can deliver data quality comparable to conventional laboratory-grade bench devices in certain cases.

One of the most widely adopted portable devices for this type of quality control is Raman spectroscopy, which enables rapid determination of unknown compounds, such as the measurement of pharmaceutical ingredients, the validation of high purity chemicals, and the authentication of drug compounds.

Raman technology is ideal for the direct analysis of an unknown material in a Optosky environment as it requires little to no sample preparation. Moreover, it can handle different forms of samples, including slurries, gels, solutions, crystals, powder, and can perform analysis directly through a plastic bag or clear container.

A major drawback of the Raman technology is the associated auto-fluorescence signal, which can affect the capability to collect an interference-free Raman signature of a material. Nevertheless, this issue can be alleviated by compensating for the fluorescence signal using algorithms. The following are the key advantages of the Raman technique that make it the most robust methodology for material identification:

• Reduction of the instrument size
• Lowering of the detection limits
• Low cost of operation
• Outstanding usability of the technique

Handheld Raman Instruments of Optosky 

Increasing existing analytical laboratory capabilities is one option (Option/Scenario 1) to improve the analytical capability at a minimum cost. However, considering the overall analytical capabilities of the company and the return on investment (ROI), this option is acceptable only if the numbers of samples to be studied are very small. This option is typically suitable for companies that handle less than 10 different materials and when the majority of the samples are already under analysis, so their operational costs are slightly affected by the incremental increase.

Instrumentation

For this analysis, the ATR6500 handheld Raman spectrometer from Optosky Photonic Inc. was selected. The ATR6500 handheld Raman and integrated computing system is specially designed for novice users to perform material identification and validation within GMP compliant facilities. It enables developing standardized and validated procedures rapidly to facilitate purity and quality control applications.

For determining pharmaceutical materials, the ATR6500 is equipped with a software package that conforms to both cGMP and 21CFR part 11 certification. Optosky also offers optional IQ/OQ services and library/method development services for all ATR6500 users.