rap.ID Begins Implementation of SPE Biopharma

rap.ID Particle Systems GmbH launched the SPE BIOPHARMA 0.5 in 2009. The robust device is a new and powerful tool designed for system integration engineers; the SPE raman+metal promotes the development of future-proof control solutions, reducing the cost of upgrades and future maintenance.

The SPE 0.5 Biopharma identifies particles and agglomerates between 0.5-10 nm recovered from biopharmaceutical intrinsic particles. Even particles as small as 0.3 nm are visible after illumination and calibration. The speed of this process enables the the equiment to conduct silicone protein interaction studies or other formulation stability related investigations.

easuring and identifying nano particles is now as easy as a touch of a button. The device conducts silicone protein interaction studies or other formulation stability related investigations. All the raw data including raw images, analyzed images, particle morphology, particle stitch merging, and spectra are then stored in a “results” file in compliance with 21 CFR Part 11.

Applications:

• Streamlined stability studies
• Development and control of Biopharmaceuticals
• Pharmaceutical Water for Injection (WFI) monitoring
• Preventive quality assurance (CAPA) in the production of parenterals
• Continuous monitoring of the chemical composition of foreign particles for process optimization (Clean Intelligence)
• Quality Assurance routine counting 4 min/sample with possibility to immediate response to out of spec situations (OOS) or out of trend (OOT) through integrated particle ID