SPE-ls CSS – Membrane Particle Counting
USP <788> outlines methods used to measure "subvisible particulate matter" found in injectables. rap.ID contract testing laboratory conducts routine analyses as well as white and gray standard nitrocellulose analyzation of membranes 25 mm and 47 mm in diameter according to USP<788>. A 25mm standard sample can be analyzed in as little as 2 minutes using high throughput processing. The automated procedure is quick and requires little human interaction. Samples can be either sent to a central lab using rap.ID analytical equipment or straight to the rap.ID contract-testing lab.
SPE-ls raman.ID - Particle Counting and Statistical Particle Identification
This model identifies hundreds of particles ranging from 5 µm and larger per hour. The fully automated system provides statistically relevant data resulting in proactive quality assurance and high quality biopharmaceutical development. Develop and control parenterals using high throughput Quality by Design principles and requiring little human interaction.
SPE-ls raman.ID + metal.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 0.5 µm in medical devices and sterile pharmaceutical products such as parenterals.
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 bacteria count and the implications of such germs requiring very little human assistance. This particular model of SPE can detect pathogenic bacterial contamination even in troublesome pathogenic germs. The data from the analysis is stored in a “results” file in compliance with 21 CFR Part 11.
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