문서 공유
Raw material identification and verification (RMID) is a complicated process for a very important reason: it confirms the quality of the raw materials used in the manufacture of products that you put on and in your body. The complexity of RMID spans the spectrum from analytical techniques and instruments to the testing process, then to the governmental norms and standards that regulate all aspects of RMID including system suitability, extent of sampling, method validation, electronic records, and many others.
Warehouse verification of incoming materials with mobile Raman in regulated industries involves performing RMID directly at the loading dock. Therefore, chemical analyses that historically would be performed in a laboratory by trained chemists can now be performed very quickly and with great success by nontechnical professionals.
Beginning with System Suitability…
Producers of handheld Raman instruments for RMID must provide suitable calibration and validation routines. Calibration of MIRA P with the Calibrate/Verify Accessory (CVA) accomplishes instrument calibration as well as system and performance verification, then summarizes these tests in the System Suitability Test (SST) report for MIRA P. CVA ensures that MIRA P performs as intended and that users can trust in the generated data quality. Upon completion of the SST, users are assured that all measurements are in accordance with agreed standards.
For more information about instrument calibration, system verification, and performance validation for Metrohm Instant Raman Analyzers (MIRA), download our free White Paper below.
Instrument Calibration, System Verification, and Performance Validation for Metrohm Instant Raman Analyzers (Mira)
Analytical Instrument Qualification (AIQ) according to the United States Pharmacopeia (USP) ensures that instruments perform as intended and users may have confidence in data quality. As the Pharma industry adopts handheld Raman instruments for incoming materials identification and verification, producers of such systems must provide suitable calibration and validation routines. Upon completion of these tests, end users are assured that all measurements are in accordance with agreed standards at Metrohm Raman, we have sophisticated AIQ routines in place to confirm the quality of your results.
Moving on to Sampling Flexibility…
RMID methods must accommodate a number of factors to create the most accurate and robust solution for the task. Specific consideration must be given to:
- The sampling strategy: how to collect the best quality data, given specific conditions
- Sample presentation: including morphology, packaging, and chemical nature
Handheld Raman is recognized as a particularly well-suited technique for RMID, as it offers portable, onsite, no-contact analysis of solid and liquid samples.
RMID for Regulated Industries Part I: General Considerations outlines basic applications of handheld Raman, including sampling considerations and types of evaluation. Metrohm Raman simplifies sampling with Smart Tips for every sample type.
RMID for Regulated Industries Part I: General Considerations
Followed by Method Development…
From Training and Validation Set building and specific recommendations for collecting best quality spectra to dedicated software routines that automatically determine optimal model parameters, MIRA P streamlines development of methods for RMID with handheld Raman.
RMID for Regulated Industries Part II: Method Development
RMID for Regulated Industries Part III: Method Robustness and Validation
Successful development of a method relies on the inclusion of spectra in libraries and training sets used for RMID. Careful planning in the design phase of the model leads to an easy data collection phase. This data can then be used to determine the best model parameters for robust method development. With Mira Cal P and ModelExpert, even non-technical users can implement accurate, effective RMID methods.
Download our free Application Note below for more information about Simplified RMID Model Building with Mira Cal P and Model Expert.
Simplified RMID Model Building: Mira Cal P and Model Expert
And Method Implementation…
Implementation of handheld Raman in RMID, where the majority of materials testing is performed in the receiving area, is a logical step for such a powerful technique. It has become widespread due to some very real advantages.
- Massive time savings: acquisition times of less than a minute, coupled with instant, obvious results, permits very high-throughput
- Faster turnaround: delivers materials to production sooner
- Reduced resources: less demand for laboratory and warehouse personnel and lab consumables, costs, and workloads
- Guided Workflows: predefined workflows on MIRA P make sampling simple and efficient
Download the guide for method implementation below.
RMID for Regulated Industries Part IV: Method Implementation
With Full Compliance and Utter Confidence.
Just as MIRA P has built-in routines to ensure instrument integrity, Mira Cal P is designed to protect customer data integrity and simplify compliance with worldwide norms and standards. All RMID customers require data to be complete, consistent, and accurate, and Mira Cal P goes beyond this with full transparency and traceability.
Mira Cal P analytical software from Metrohm Raman gives you peace of mind, as it ensures all data processing adheres to several standards. More information about data integrity can be found in our free flyer.
Peace of mind with Mira Cal P – Compliance with the Data Integrity Guidelines made easy
RMID is a complex process. Learn more about how handheld Raman can provide the simplest, most efficient and accurate RMID experience possible.
Your knowledge take-aways
Handheld Raman spectrometers and SERS analyzers for the lab and the process
White Paper: AIQ for Mira analyzers
Download this White Paper to learn more about the AIQ routines for Mira analyzers:
