GMP accredited labs check the quality of primary packaging containing drug products. The testing and qualification of plastic packaging systems and components for pharmaceutical use are covered in Plastic Packaging Systems for Pharmaceutical Use <661.2>. A plastic material of construction is deemed to be well-characterized for its intended use if the following characteristics have been adequately established: its identity, biocompatibility (biological reactivity), general physicochemical properties, and composition (i.e., additives and extractable metals likely to be present).
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 DSC 8500 is a double-furnace DSC, featuring our second-generation HyperDSC® technology. Now you can gain unlimited insight into the structure, properties, and performance of your materials. With hyper-enabled, double-furnace technology and better application capabilities, the DSC 8500 gives you higher accuracy and sensitivity. The HyperDSC heating and cooling with extremely fast controlled scanning rates and in-situ ballistic cooling is important for applications such as isothermal crystallization, polymorph/amorphous-material studies, and high sensitivity measurements.
TGA 8000™ gives you complete control over your sample environment while delivering enhanced performance, maximum application flexibility, high throughput and reliability – even unattended. Plus, our advanced hyphenation technology works beautifully with FT-IR, MS, GC/MS, and more for greater understanding of evolved gases.
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.
PYRIS™ Enhanced Security Software enables 21 CFR Part 11 technical regulatory compliance to help users in both research and quality control to comply with the stringent data security requirements of regulated industries. Key features of the PYRIS Enhanced Security Software include user level management, file protection, audit trails, and electronic signatures. The electronic signature capability is integrated into the software, providing customers with a complete package from a single source. The PerkinElmer PYRIS Enhanced Security option is fully compatible with thermal analysis instruments running on the PYRIS software platform.
