PerkinElmer's new Spectrum AssureID materials checking system significantly enhances profitability in pharmaceutical QA/QC applications
PerkinElmer's new Spectrum AssureID materials checking system assists the highly regulated pharmaceutical industry by supporting the development, manufacture, and validation process from product conception to production, at-line and in real-time. AssureID mimics the QA/QC workflow and guides even non-expert users through the rapid development of simple, robust and reliable testing methods, for fast, easy, economical implementation.
It can help maintain and update methods as they are optimised over time.
The pharmaceutical industry requires rapid confirmation of material identity, quality or fitness-for-purpose throughout the development and manufacturing process.
Such verification is required at many stages, from raw materials inspection through intermediates and work-in-progress, to final product and packaging testing prior to shipping to customers.
It is achieved by measuring the "sameness" of the material based on its recorded near-infrared or mid-infrared spectrum rather than physical properties.
The Spectrum AssureID utilises the Simca algorithm and PerkinElmer's patented Compare algorithm to minimise atmospheric and instrumental deviations in the spectra and enhance spectroscopic differences arising from varying component concentrations or impurities.
Its sampling accessories permit the analysis of powders, films, solids and liquids without sample preparation.
The system is fully compliant to GxP, 21 CFR Part 11 and ISO 9001 regulations.
Built-in data and result audit trailing minimises the cost of proving compliance.
Spectrum AssureID is also invaluable in the petrochemicals industry, or wherever reliable, economical and rapid QA/QC is a prime concern.
