What are some critical issues pharmaceutical companies are facing regarding their analytical testing procedures?
Data integrity with regards to 21 CFR part 11 compliance.
What does Bruker offer to assist with the fast and accurate analysis of pharmaceutical compounds?
A QC module for pass/fail results that includes daily PQ and scheduled OQ validation.
Data acquisition and analysis is a huge part of a pharmaceutical lab’s functions. Can you tell me about the software solutions Bruker offers to help manage and analyze all this data?
Bruker provides a full suite of analysis capabilities from simple manipulations to the intricate evaluations. Cluster analysis, identification, and multivariate quantification are a few of the many options that are typically tailored to the required analysis problems.
BRAVO™: The first next-generation, hand-held Raman spectrometer with patented fluorescence mitigation SSETM (Sequentially Shifted Excitation) now enables measurements of a wider range of raw materials, compared to first-generation systems. Specifically designed for the pharmaceutical industry, BRAVO’s intuitive user interface and touchscreen provide a superior guided workflow. BRAVO features Duo LASER™ excitation with two wavelengths resulting in high sensitivity across the largest spectral range. Additional features include automated wavenumber calibration for highly precise measurements and the automated measuring tip recognition IntelliTip™, which ensures that the proper measuring tip is used. BRAVO is a handheld Raman spectrometer that is certified as class 1M Laser product for all measurement modes, making training and operations easier and safer.When a pharmaceutical company is looking for spectrometers what are some key features they need to have?
21 CFR part 11 compliance, (individual login, data log, network compatibility.
What questions should they ask a potential vendor of spectrometers?
Where does the service person and their back-up reside? Compliance? Resolution?
Can Bruker’s technologies for pharmaceutical analysis be integrated into a seamless lab analysis solution?
Amgen is attempting this.
What services does Bruker offer to help companies integrate products for maximum versatility, efficiency, and accuracy?
Bruker is a GMP manufacturer that provides infrared and Raman spectrometers with full validation packages that are readily integrated into almost any SOP. This applies to traditional spectrometers as well as infrared and Raman imaging systems provided by Bruker. This is unique to Bruker.
Looking ahead, how will Bruker continue to service the lab analysis needs of its current and future customers?
Bruker continues to place a high importance on the needs of the pharmaceutical industry. Product development continues to be focused on broad markets and the pharmaceutical market is among the most important in carefully determining market growth opportunities.
Are there new products and technologies on the horizon that the company is looking to introduce?
Bruker introduced Novel Mass Spectrometry Solutions for MALDI Imaging, Metabolomics, Proteoform Profiling and Toxicology at ASMS 2017 and new solutions for Microbial Strain Typing, Hospital Hygiene and Infection Control at the ASM Microbe 2017 Meeting.