If you work within the pharmaceutical industry, then you know that strict regulatory guidelines govern Quality Analysis and Quality Control. In order to maintain compliance, these regulations often dictate that certain measures or process improvements must be implemented. Keeping pharmaceuticals at peak quality means consistent and rigorous analysis at all stages of the manufacturing and distribution process. Without maintaining strict quality control procedures, companies risk product inefficiencies and heavy fines for non compliance.
Raw Material Identification
A key part of Quality Control is raw material identification. Complex brokerage agreements can mean that a product may be repackaged or relabeled multiple times. In order to accurately identify the contents of each container of starting material, appropriate measures must be taken. The receiving party should conduct its own identity checks rather than relying on the supplier of the material to have documented and labelled the material correctly. Doing so will mitigate the risk of contamination which can occur, either accidentally or purposefully.
Some companies rely on a process of raw material identification which includes sample analysis. However, opening containers for the purpose of analysis risks contamination. This has led to the adoption of Raman analysers, which will allow the user to test the contents of a container through its packaging.
At the forefront of this technology is the handheld Raman spectrometer, which provides portable, lab quality analysis of raw materials. Choosing to conduct your raw material identification and verification processes with a handheld Raman spectrometer can provide significant savings from both a time and spend perspective, allowing you to receive on the spot analysis of raw materials without having to wait for results or risk contamination. But which is the best one for your business?
Introducing the Progeny™ Handheld Raman Spectrometer
The Progeny™ spectrometer was designed specifically for raw material identification and fits comfortably in your hand, making it a truly portable and flexible device. It’s easy to read interface has an intuitive design for simple, one-handed navigation.
However, the real beauty of the Progeny™ is that it can analyse all materials including powders, solids and liquids. The Progeny™ can offer either pass/fail confirmation or more detailed analysis by accessing its built-in library of over 12,500 substances. Operators can also access a customised library of more focused results, depending on the needs of the user. This clever device can document processes through its barcode scanner and integrated camera, and facilitates wireless data transfer helping to maintain traceability in all aspects.
The Progeny™ allows your business to remain legally compliant by offering a full IQ/OQ/PQ protocol package, with unique 21 CFR Part 11 compliant digital signatures. Here at Antech, we know that sometimes seeing is believing. If you have an interest in arranging a demonstration then get in touch!
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