The analysis of all incoming pharmaceutical raw materials is a key part of GMP compliance to guarantee safety and efficacy of a finished dosage form which is largely dependent on the purity and quality of the bulk active drug substance and excipient.
The drug substance manufacturer must have complete knowledge of the manufacturing process and the potential impurities that may appear in the drug substance and excipient. It is therefore important to have a high-throughput method by which raw materials may be analysed in a loading bay or warehouse, while also preventing sample exposure to avoid contamination.
The suitability of drug substance for its intended use is defined by attributes such as identity, strength, and purity – which can be achieved by using our instruments, consumables, and services.
The 21 CFR Part 11 technically compliant Spectrum ES software suite is designed for regulated industries that demand secure IR quality testing. The Spectrum 10 ES suite encompasses the comprehensive features of Spectrum 10™ and encompasses user access control, audit trailing, data security, and data integrity to ensure secure analyses. The software package includes instrument control, basic and advanced data manipulation routines, a spectral calculator, COMPARE spectral comparison, PLS/PCR/Beer’s Law predictions, Report Builder, Report Viewer, and Administration Utility.
The Spectrum Two™ FT-IR spectrometer delivers everything required to perform FT-IR analyses within regulated environments with complete confidence in the results. From rapid raw material identification to sensitive analysis of formulated products, the Spectrum Two system offers the best user experience without any compromise in analytical performance. With fully integrated, robust universal sampling for trouble-free measurements and portability options, this system is ideal for use in both laboratory and remote testing environments.
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.
The Frontier™ FT-IR/NIR system enables you to benefit from faster method development and reduced instrument costs with a single optimized system for mid-IR and near-IR performance. Automated range switching enables you to quickly move onto your next sample without manual reconfiguration. The system can be upgraded to a Spotlight™ microscope system, have an external optical bench added, or be configured with an upgraded detector at any time.
For regulated industries that demand secure IR quality testing, Spectrum 10 ES™ software is available and encompasses user access control, audit trailing, data security, and data integrity to ensure secure analyses to meet the technical demands of 21 CFR Part 11 compliance. The revolutionary Spectrum AssureID™ software is available and can provide manufacturing QA/QC functions with a rapid, unambiguous means of verifying identity and quality of a production material.
Our accessories, consumables, methods, and application support meet the most demanding requirements and are the preferred choice in thousands of laboratories globally.
We invest heavily in testing and validating our complete portfolio of solutions to ensure that you receive accurate, repeatable results – on-time, every time – throughout the lifetime of your instrument. We also offer a complete portfolio of specialized consumables that deliver reliable performance, control operating costs, and maximize the uptime of your instrument.
The OneSource® UOQ program provides an instrumentation qualification program for maximum productivity and ongoing regulatory compliance capability. The program encompasses pharmacopeial (USP, EP, and JP) compliance with a design and approach that streamlines documentation across all major models of laboratory instruments, regardless of manufacturer.
OneSource Compliance Services ensures the highest levels of compliance with international regulations and guidelines. UOQ enables a seamless, cross-platform approach to a contemporaneous and automated documentation process, letting you gain immediate access to raw data from computer or database, for increased scientific productivity.