SPE-ls CSS – Membrane Particle Counting
USP <788> outlines methods used to measure foreign particles in injectables. rap.ID contract testing laboratory conducts such analyses as well as white and gray standard nitrocellulose analyzation of membranes 25 mm and 47 mm.
SPE-ls raman.ID - Particle Counting and Statistical Particle Identification
This model identifies hundreds of particles from 5 µm and larger per hour. The fully automated system provides statistically relevant results allowing for proactive quality assurance and the development of high quality biopharmaceuticals. Develop and control parenterals using Quality by Design principles to achieve high throughput, while requiring fewer human resources.
SPE-ls metal.ID + raman.ID - Elemental Distribution and Chemical composition identification
The system identifies the exact chemical composition/elemental distribution, count, shape, and size of particles at a throughput rate of 100-1000 per hour. The equipment is designed to conduct parts cleanliness testing as well as identify foreign particles larger than 5 µm in medical devices and sterile pharmaceutical products such as parenterals.
SPE raman.ID biopharma - Biopharmaceutical Solutions
The SPE biopharmaceuticals identifies particles and agglomerates recovered from biopharmaceutical intrinsic particles. The speed of this process enables the the equiment to conduct silicone protein interaction studies or other formulation stability related investigations. Measuring and identifying nano particles is now as easy as a touch of a button.
SPE raman.ID 0.5 - Bio Particle Explorer(BPE) - Micro-Contamination solutions
The BPE is able to determine and identify the viability of a single microorganism. Microbial strains of micro-contamination can be distinguished from a single germ. The automated technology quickly determines the entire bacteria count and the hazardous potential of such germs with very little human assistance needed. This particular model of SPE can detect pathogenic bacterial contamination even in troublesome pathogenic germs. The data from the analysis is thus put in a “results” file in compliance with 21 CFR Part 11.
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