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Analyzing incoming raw materials using Raman Spectroscopy in pharma

Overview

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Source: Metrohm India Private Limited

Date: 04 May,2022

Handheld Raman instruments have become globally accepted tool for quick analysis incoming raw material identification in the pharmaceutical industry. The speed of analysis allows the customer to move beyond traditional statistical sampling to 100% container identification.

Considering the growing importance of Raman spectroscopy, Pharmacopeia chapters are updated with more information and guidance for the system. Recently USP has replaced of USP <1120> Raman Spectroscopy with two new chapters, USP <858> Raman Spectroscopy and USP <1858> Raman Spectroscopy– Theory and Practice. European Pharmacopeia has also revised and updated chapter EP.2.2.48. The updated chapter 2.2.48 was published in the Ph. Eur. Supplement 10.7 of October 2021 and will take effect April 1, 2022.

Our state-of-the-art Handheld Raman systems, NanoRam and NanoRam-1064 are calibrated in compliance with the wavelength accuracy criteria for qualitative Raman measurements set forth by all global pharmacopeia’s, including the new USP <858> and <1858> chapters, EP 2.2.48. The system software of the NanoRam and NanoRam-1064 includes performance validation testing using Raman shift standard materials as defined by ASTM E1840 Standard Guide for Raman Shift Standards for Spectrometer Calibration. The performance validation report shows the Raman shifts measured during the validation against the specification for the tolerances for polystyrene set forth by the USP <858>, EP, and JP Raman chapters for handheld Raman or qualitative analysis.

Raw Material Identification is an important step in the pharmaceutical manufacturing process.

B&W Tek NanoRam and NanoRam 1064 Handheld Raman spectrometers offers a comprehensive package of Robust instrument, easy to use software, a wide range of sampling accessories, and compliance with updated pharmacopeial requirements.

The NanoRam systems include a variety of sampling accessories optimized for the measurement of materials in the form of liquids, gels, powders, or solids under both a laboratory setting and demanding environmental conditions.

Please find below a table with our complete range of standard as well as optional sampling accessories for the NanoRam and NanoRam 1064 system along with the typical application usage of each accessory.

Accessory	Application usage
Vial holder	For measurement of liquid, gel and powder samples in 15mm vials
Point & shoot Adaptor	Ideal for infield sampling of materials and is capable of measuring through plastic and glass containers.
Contact Immersion probe	Immersion Probe for Easy Measurements Beyond the Surface of Materials in Bottles and Drums. Allows for in situ measurements of liquids and powders, and measurements of larger containers only accessible from the top
Tablet holder	Allows for a flexible sampling of tablets and a lid to hold the tablet in place while it is measured.
Right-angle Adaptor	This right-angle attachment improves accessibility and is ideal for measuring samples with large surface areas. Additionally, this accessory can be used to perform hands-free measurement by “sitting” a NanoRam with the adapter on a sample surface, which may be desirable for certain application tasks.
Bottle Adaptor	The bottle adaptor for the NanoRam and NanoRam-1064 handheld Raman spectrometer features a curved light shield in order to reduce interference from ambient lighting. Additionally, the bottle adaptor has a longer working distance allowing the laser to focus deeper into the container, mitigating interference from thick containers.
Large bottle Adaptor	Large bottle adaptor with 10mm working distance for the NanoRam-1064. It features a curved light shield in order to reduce interference from ambient lighting. This works well with larger and thick-walled glass bottles.
Large Spot Adaptor for covering a Large sample area (For NanoRam 1064)	The large spot adaptor (LSA) with a large sampling area has the advantage of preventing sample damage by reducing the power density, as well as improving measurement accuracy by eliminating heterogeneous effects from the sample. In addition, the design enhances the relative intensity of the signal from the deeper layers, thereby increasing the effective sampling depth.

Advantages of Large Spot Adaptor

The large spot adaptor (LSA) for B&W Tek’s handheld Raman products, features a much larger sampling area of 4.5 mm in diameter.

The large spot adaptor (LSA) with a large sampling area has the advantage of preventing sample damage by reducing the power density, as well as improving measurement accuracy by eliminating heterogeneous effects from the sample. In addition, the design enhances the relative intensity of the signal from the deeper layers, thereby increasing the effective sampling depth.

For more details on our Handheld Raman instruments, please contact us through [email protected] or visit our website https://www.metrohm.com/en_in.html