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The Bioprocess Measurements Group at the National Institute of Standards and Technology (NIST) located at Gaithersburg, MD provides measurement science and standards for robust characterization of biologically or synthetically derived particles that are relevant in the biomanufacturing industry. These particle types can be hard to distinguish, and regulatory guidelines require detailed characterization of these particles in drug products. Industry currently relies heavily on flow imaging microscopy and light obscuration (compendial method) for characterizing these particles in their products.
We are requesting an updated flow imaging instrument with light obscuration capabilities to replace two outdated, unsupported systems (Flow imaging and Light Obscuration) which no longer reflect instruments used in industry which limits data comparability and collaboration.
The contractor shall provide a commercial flow imaging microscopy instrument with light obscuration capabilities suitable for measurement of sub-visible particles in liquid suspension, including data collection and analysis software, consumables, shipping, installation, and on-site training for up to three people. The instrument must meet minimum salient characteristics such as a 2 µm to 70 µm particle size range, 10X magnification, autofocus, and compliance with USP <787/788>. The contractor shall also provide an operations and maintenance manual, install the instrument at NIST Gaithersburg, MD, and provide a one-year warranty covering parts, labor, and travel.
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