New device uses spectroscopy to speed up particle ID

Germany's rap.ID Particle Systems has launched a new lab-ready particle identification device capable of identifying around 400 particles an hour from 5µm and up. The company says the device is suited for development and quality assurance in the pharmaceutical industry. The Advanced Single Particle Explorer aims to vastly speed up a process that is currently stifling research, adding to costs in an already budget conscious sector. A conventional lab needs about a week to chemically identify the 20-40 largest contaminating particles. The process alone can cost up to $6000. With the new device, rap.ID Particle Systems claim to deliver the same results in 25 minutes, needing only 3 minutes to filtrate the sample using the filtr.AID Membrane. The sample is then loaded into the machine, analysis mode selected and pressing start to begin the process. The device's fully-automated image analysis feature, coupled with Raman spectroscopy results in the measurement of size, count, and shape of over 10,000 particles from 5µm and up. The technology has applications for laboratory researchers working in the pharmaceutical industry toward development and quality assurance for injectables, nasal sprays, and inhalants as well as medical implant manufacturers. Identification of small particle contamination is crucial in the pharmaceutical industry, where drugs and tablets need to be essentially free of visible foreign particles with strict limits on subvisible particle numbers allowed. Contaminants are usually first noticed during internal quality control inspection. Spectroscopic analysis is particularly well suited to the analysis of particulate contamination because the particles are usually too small to be analysed using conventional methods. Proper methods of sample isolation and preparation are also critical to the successful identification of particulate contaminants. Equipped with autofocus and automatic particle recognition, rap.ID Particle Systems claim the device delivers complete particle size distribution analysis in approximately 1 minute. This is achieved by spectroscopic parameters (exposure and laser intensity), which are determined by the system itself. Material composition is determined through comparison with the integrated database. Results are then combined with the raw data (particle images, image recognition and material classification, spectra) in a 21 CFR Part 11 compliance document. "The user is able to check calibration of the instrument to these standards in just a few minutes​," the company commented. "The system has been validated for multiple applications and is standing by with integrated labour for further method development and validation, or for feasibility studies​," they added. Background particle presence that may be a normal non-hazardous part of the manufacturing process can be filtered out using this device and other potential contaminants can be quickly isolated and detected. There are two general types of contaminants normally found in the pharmaceutical research and quality assurance processes. There are contaminants related to the active ingredient, excipient materials or colorant. Particles may be generated from the product container or packaging material. These types of particles include glass, rubber, aluminum, plastics and paper. Contamination can also result from the manufacture of the product; examples of these include charred product, detergents and lubricant oils. Metal and metal corrosion, Teflon, graphite and rubber particles are indications of tank, filter or equipment failure. Environmental contaminants such as fibres and skin cells are also found. The most common contaminants in pharmaceuticals are cellulose (cotton and paper) fibres, synthetic fibres, silicone, plastics, rubber, metal particles and corrosion products, glass particles and vial delamination flakes, skin flakes and char particles. "The statistically relevant analysis made possible by the device's capabilities facilitates the search for potential contamination sources. Background particle presence that may be a normal non-hazardous part of the manufacturing process can be filtered out while, other potential contaminants are quickly isolated and detected​," rap.ID said. The Advanced Single Particle Explorer uses a four-fold sample changer for routine studies. Validation of the system's IQ, OQ, and PQ with delivery standards and particle norms is undertaken by our worldwide qualified service partners and takes only a half a day. The Advanced Single Particle Explorer is available now to purchase with pricing dependent on customer requirements.