Pharmaceutical Applications
Pharmaceutical and Biotech companies are starting to implement faster, more reliable analysis methods both throughout their research and development centers and within the manufacturing process. Today, Bruker Optics fulfills many of the needs of the Pharmaceutical and Biotech industries, ranging from quality control to process monitoring, by implementing spectroscopic solutions such as:
- Utilizing Process Analytical Technologies ( PAT ) for Pharmaceutical Industry
- Raw material identity and purity check at the receiving dock
- Real time monitoring of blend uniformity, blend ratio and drying processes
- In-line control of solvent recovery Quality control of final product for potency, excipient level and moisture content
- Whole tablet analysis in both transmission and diffuse reflectance modes
- Polymorph analysis with fluorescence free FT-Raman
- Polymorphism screening of new drug substances using high throughput screening
- Drug discovery
- Proteomics
- Bacteriology and Microbiology
- Counterfeit Drug Determination
- Contactless Check Weighing in pharmaceutical production
Developing and marketing new pharmaceutical products has forced the regulation of research and development programs. All pharmaceutical companies marketing, or intending to market, their products to the US must comply with the 21 CFR Part 11 regulations as defined by The Food and Drug Administration (FDA). These regulations control the integrity of electronic data records and electronic signatures and any other information represented in a digital form. The importance of authentication and software security is increasing due to the expansion in the use of computer-based instrumentation and the requirement to regulate and record access to computer resources as well as manage electronic records residing on these computer systems. It is therefore now one of the main factors to consider when implementing environments that will manage electronic records as set forth in FDA regulations.
The latest Bruker Optics OPUS 6.5 software package has been developed, tested and validated in compliance with the requirements of 21 CFR Part 11. Data integrity compliance is provided by a secure log-in, multi-level user access groups for users with different permission levels, and audit trails, recording all logins, illegal logins and password changes as required by the Food and Drug Administration.
One of the first steps in the manufacturing of any pharmaceutical product is the identification and validation of various incoming raw materials. NIR spectroscopy via fiber optic probes is rapidly becoming a standard method of accomplishing this crucial material validation, providing unprecedented speed and flexibility for identification of both solid materials and liquids. Bruker Optics offers a complete turn key system for quick and accurate identification of raw materials. Both MPA and MATRIX- F FT-NIR spectrometers can be equipped with fiber optic probes for direct analysis of raw materials in their containers. Complete identification software guides the user through the library creation process and provides single click identification even at the loading dock. The MATRIX- F system comes with a NEMA rated enclosure enabling it to withstand the toughest plant environments.