Foreign Particle Material Identification is a key step in the quality control of medicines and is used to identify contaminants in drug products which might affect the quality and safety of a drug product. It is a crucial step to resolving contamination issues in the quality control laboratory.
Foreign Particle characterization of the bulk Active Pharmaceutical Ingredient (API) or Suspension is essential and that is why PerkinElmer provides state of art instrument and software for FT-IR so you can feel confidence in compliance.
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.
Spotlight™ IR microscope systems are designed to meet the challenges of pharmaceutical industry by generating high-quality, reproducible data from a variety of sample types. The Spotlight 400 FT-IR imaging system combines high sensitivity and rapid imaging with ease-of-use. The ability to image large sample areas rapidly at high spatial resolution extends FT-IR microscopy into new applications. The Spotlight 400 FT-IR imaging system is designed with state-of-the-art technology to allow for intelligent automation and sophisticated analysis capabilities.
Unique features of the Spotlight 400 system include:
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.
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.