The Spectrum Two N™ is a high-performance, yet robust and transportable FT-NIR system platform enabling simple, reliable NIR analyses. It’s the perfect system for labs that need to combine high-end performance with the ease-of-use features of a portable instrument, allowing users with different levels of expertise, from novice to seasoned professionals, to be proficient with it in no time.
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High Performance FT-NIR That Goes Where You Go
Spectrum Two N FT-NIR spectrometer distills 75 years of PerkinElmer spectroscopy into a compact, high-performance yet robust FT-NIR. Simple to use, dependable and adaptable with optimized “plug-and-play” sampling accessories and modules coupled with a comprehensive software platform, Spectrum Two N systems are suited to a wide range of applications. Whatever your specific NIR application needs, in or out of the lab, the Spectrum Two N delivers outstanding performance and reliability to provide high-performance, dependable NIR measurement solutions.
Spectrum Two N FT-NIR spectrometers feature:
For Every Application
PerkinElmer recognizes that every application is different. The result is a complete solution to provide the fastest assurance of the quality of your materials, regardless of the application. Some of the industry applications that the Spectrum Two N is designed to accommodate include:
For these specific applications, we offer various “plug-and-play” sampling accessories and modules enhancing the versatility of the Spectrum Two N FT-NIR.
|21 CFR Part 11 Compatible||Yes|
|Operating Range||5 - 45 °C|
|Product Brand Name||Spectrum Two N|
|LiTaO3||Spectrum 10 ES||L1390022|
|InGaAs||Spectrum 10 ES||L1390024|
NIR Spectroscopy is a useful technique for raw materials identification and verification, but the sophistication of the technique might differ based on the sample. If the materials to be identified are spectroscopically dissimilar, it is often only necessary to use a simple distance measure such as a spectral difference for identification. If the spectra are similar, on the other hand, it may be necessary to use more sophisticated techniques which take into consideration both the intra- and inter-material spectral variation for identification and classification. The SIMCA (Soft Independent Modelling of Class Analogy) algorithm, a Principal Component Analysis (PCA) method, provides such an example.
Herbal lifestyle products are widely used as alternatives to medicines around the world, with as many as 80% of people using them as a primary source of healthcare in developing countries. These treatments are commonly regarded by scientific papers, and on some occasions the media, as being inferior to orthodox treatment. This is due to the variation between herbal formulations which will not be present in so called ‘single-chemical’ drugs. The reasons for the aforementioned variation involve several factors including storage, environmental conditions, handling and unintentional or intentional contamination (adulteration).
The exact number of counterfeit medicines produced/consumed each year is difficult to determine due to the usually illegitimate methods by which they are distributed. However, the scale of the problem can be represented by the fact that 20 million pills, bottles, and sachets of counterfeit medicines were seized in a five-month operation conducted by the International Criminal Police Organization in China and South-East Asia.
Near-infrared (NIR) spectroscopy is an important technique for materials checking at various stages of the manufacturing process, but is particularly useful at the raw materials inspection stage. Raw materials come in a variety of physical forms including liquids, gels, and solids, requiring a versatile instrument with convenient, interchangeable sampling modules to cater to the entire range of raw materials encountered.
Infrared (IR) and near-infrared (NIR) spectroscopy are fast, easy-to-use techniques with a history of being used for food applications such as those for measuring protein, moisture, and fat content. Food fraud and adulteration has become of particular concern to the industry over the past few years following reports of incidents in the media, with herbs and spices identified as one of the key problem areas.
Product Certificate for Spectrum Two N
The FDA defines data integrity as “completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)”. ALCOA itself has evolved to ALCOA Plus, which incorporates two of the fundamental definition terms as stated by the FDA; complete, consistent, enduring, and available. Compliance with 21 CFR Part 11 is mandatory for pharmaceutical companies and their suppliers to sell products into the United States, and also applies to other related industries.
PerkinElmer’s Spectrum™ 10 Enhanced Security (ES) software platform for infrared spectroscopy provides structural requirements and features to assist with the needs for ensuring data integrity and compliance. It affords the system owner the ability to comply with regulations and incorporate features into the validation plan to exhibit compliance. The purpose of this document is to demonstrate how Spectrum 10 ES meets the technical requirements for 21 CFR Part 11.