EnSpectr Raman spectrometers for in-field pharmaceutical product checking & incoming raw material authentication
EnSpectr portable spectrometers allow rapid measurements of liquids, powders, tablets, and gels through transparent and semi-transparent packages. EnSpectr has developed unique handheld Raman-luminescent spectrometers that perform quantitative analysis of ampouled active substances in concentrations down to 1%!
In addition to in-situ tasks EnSpectr portable spectrometers are sucessfully used for:
— Pharmaceutical polymorphs identification and classification;
— Real-time monitoring and control of pharmaceuticals drying, coating and blending;
— Identification of drug co-crystals, etc.
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Compliance with international quality standards such as GMP EU and 21 CFR 11 is vitally important for pharmaceutical companies.
Enhanced Spectrometry, Inc. helps you to ensure rapid raw materials quality analysis as well as final product checking. EnSpectr professional software keeps track of all measurements providing secure accounts and ultimate transparency of production.
Meeting CFR 21 requirements. EnSpectr software keeps track of all changes that affect saved spectral data.
Any action in the software that modifies the original data is logged. The log of such changes is individually maintained for each spectrum and is referred to as History in the program. To keep up with external audits proceedures EnSpectr software provides Reports generating a document with all user log event data over a specified period of time.
Meeting GMP EU requirements. According to the GMP standards, it is necessary for pharmaceutical companies to use “effective monitoring and control systems for process performance and product quality” and ensure that “medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life” which implies:
- — New deliveries quality checks,
- — Stated substances quality confirmation,
- — Component control checks before mixing with new deliveries, etc.
The EnSpectr top product for pharmaceutical field, handheld Raman spectrometer RaPort, proves to be an efficient easy-to-use solution for pharmaceutical field providing quick measurements and accurate substance identification in less than 3 seconds.