Quality Control with Handheld Raman

Ensuring compliance for raw material identification is easily within reach

By Claire Dentinger, Applications Scientist, Rigaku Analytical Devices

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Raw material identification (RMID) is a critical step for ensuring compliance with Good Manufacturing Processes (GMPs) and safeguarding the quality of pharmaceutical products. Increasingly strict regulatory requirements for RMID mean that pharmaceutical manufacturers are under increasing pressure to improve the efficiency of their RMID workflow while also achieving lower costs per analysis.

Traditional lab-based techniques for RMID can be time consuming, costly and do not support the rapid identification of incoming materials. Handheld Raman spectroscopy is increasingly recognized as an effective technique for RMID thanks to its specificity, speed and ease of use. However, devices with traditional excitation wavelength lasers, such as 532nm or 785nm, are affected by fluorescence interference which limits their ability to detect certain materials. The implementation of handheld Raman utilizing a 1064nm excitation wavelength laser removes the barriers to effective RMID while achieving ROI.

THE RMID CHALLENGE
RMID is essential to verifying whether a substance is what it should be to prevent quality issues further down the line. Incorrect formulation, contamination, mislabeled containers and counterfeit materials can result in products being “out of specification,” which can severely damage brand reputation. Ultimately, if these materials are not promptly identified and rejected, this can lead to additional costs due to material waste, re-processed work, time delays or product recalls. Effective and timely RMID helps to improve the quality of pharmaceutical products by identifying these out-of-specification materials before they enter the manufacturing process.

The traditional RMID workflow involves a number of stages before materials can be passed through for manufacturing. In order to perform comprehensive qualitative and quantitative analysis of materials, the majority of techniques used for RMID require containers to be opened to obtain a sample, which introduces the risk of contaminating the material. While the majority of pharmaceutical manufacturers now perform RMID on-site, the analytical techniques commonly used for RMID are not optimized to analyze raw materials on the warehouse floor or in the clean room. HPLC, GC and FTIR are among the commonly used techniques for RMID, and although they deliver powerful analysis, they need to be operated by highly skilled users. This could be considered a waste of a valuable resource when all that is initially required is a simple PASS/FAIL analysis.

The well known saying that “time is money” is certainly applicable to RMID. Raw materials are held in a quarantine area while waiting for verification, which takes up valuable warehouse space as well as causing delays in the manufacturing process. In the drive to achieve lean manufacturing processes it’s clear that there are elements of the traditional RMID workflow that are not optimized to deliver speed, efficiency and cost savings.

Another factor is the wide variety of materials that now require analysis, which are difficult to analyze using existing handheld Raman devices. Materials such as Polysorbate 20, cell culture media, gelatin and Xantum gum are susceptible to fluorescence when being analyzed by handheld Raman analyzers a 532nm or 785nm excitation laser. Fluorescence interference prevents the successful chemical identification and analysis of these materials which is a cause of frustration for QA/QC managers attempting to verify them quickly.

COMPLIANCE CONSIDERATIONS
Pharmaceutical manufacturers are required to comply with the regulations of local pharmacopeia and government agencies such as The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-Operation Scheme. In the majority of countries, 100 percent inspection of incoming raw materials is now required, meaning that every container needs to be analyzed. This makes it more important than ever before for the RMID process to be as efficient as possible to meet these demands without affecting productivity or profit margins.

Manufacturers are also required to pass quality audits to ensure they are compliant with Good Manufacturing Practices (GMPs) for RMID. The PIC/S Guide to Good Manufacturing Practice for Medicinal Products states that “there should be appropriate procedures or measures to assure the identity of the contents of each container of starting material” and recognizes that it is only possible to verify a complete batch of raw materials by sampling all the containers.

STREAMLINING RMID WITH HANDHELD RAMAN
Raman spectroscopy is an accepted technique by the United States Pharmacopeia (USP) and the European Pharmacopeia (EP) for RMID and is widely used as part of the pharmaceutical manufacturing process to ensure the safety and efficacy of pharmaceutical products. Raman spectroscopy is an established vibrational technique that works by first exciting a sample with a laser. This results in a Raman spectrum which contains a series of peaks that relate to features in the sample’s molecular structure. A cartoon schematic of this process is shown in Figure 1.

Handheld Raman is designed to fit seamlessly into any work environment for RMID processes. By providing the ability to analyze and identify materials against a variety of criteria at the point of need, handheld Raman eradicates the delay in waiting for results from external laboratories, improves cycle time and optimizes material movement. Ultimately, pharmaceutical manufacturers are able to easily meet the requirements for 100 percent inspection of incoming materials with handheld Raman, and a comparison between the traditional RMID and handheld Raman RMID workflow is outlined in Figure 2. Utilizing a handheld Raman device enables users to make quick decisions with easy PASS/FAIL results, helping professionals to achieve leaner manufacturing processes without compromising on the quality of the material.

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