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ASSURx Tragbarer Raman-Analysator

Artikelnr: ASSURX-G7

*Diese Seite ist leider nur in Englisch verfügbar.*

Today, pharmaceutical and biopharmaceutical manufacturers must verify materials throughout their production process to meet current Good Manufacturing Practices (cGMP). The ASSURx® Handheld Raman Analyzer is your fast and accurate handheld Raman analyzer designed to help you meet your cGMP requirements.

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Produktdetails

Verify and identify raw materials through to finished product

The ASSURx analyzer is a high performance, handheld Raman analyzer that allows users to conduct material verification in the loading dock, warehouse, lab, or field, to reduce quarantine space and expedite materials through the manufacturing process. This non-destructive, non-invasive analyzer helps identify a broad range of chemical compounds through sealed packaging. Using the ASSURx device in a material verification program removes sampling, sample handling and the laboratory from the material verification process, thereby improving manufacturing process efficiency and minimizing on the risks of material contamination and exposure.

Handheld Raman is the common method of choice for pharmaceutical raw material verification and identification due to its high specificity and broad material coverage. The ASSURx analyzer comes standard with all the most common accessories you need to conduct a comprehensive material verification program, including: tablet holder, vial holder, and 7mm focusing lens for thicker glass/packaging. Finally, TSI or TSI factory-trained representatives, provide full on-site training, conduct IQ/OQ/PQ, and support setup.

Applications

  • Incoming raw material verification and identification
  • API, excipient, intermediate and finished product verifications
  • Detection of falsified (counterfeit) medicines
  • QA/QC of final products

Use to:

  • Replace older handheld NIR with ASSURx analyzer. Raman provides larger material library capacity than NIR, and Raman accommodates liquids, including aqueous solutions.
  • Seamlessly add ASSURx analyzer to your existing fleet of ASSURx instruments. Easily transfer libraries between ASSURx-G5 and ASSURx-G7 models.
  • Start a material verification program for your pharmaceutical, nutraceutical or cosmetic manufacturing process. Portable material verification with the ASSURx analyzer is faster than lab analysis, easily meets 100% material verification best practices, and ensures supplier integrity to maintain the highest quality final product.
  • Replace expensive and time-consuming laboratory analytical methods for material verification, with portable testing at the point of interest. The ASSURx-G7 Handheld Raman Analyzer gives you a compendial method for material verification that is fast and easy.

Leistungsmerkmale & Vorteile

  • Ergonomic, gun-style point and shoot operation
  • Fast material verifications in typically 5-20 seconds
  • Broad material coverage for organics, powders and liquids
  • Direct, non-invasive, non-destructive analysis through transparent/translucent packaging
  • Efficient workflows for both individual material scans, and high volume operations with large lots of materials
  • Individual and lot reports with E-signatures
  • Fast Library development and easy library transferability between units
  • Direct connection data transfer between unit and PC/network for easy data archiving
  • Meets regulatory compliance and requirements for: cGMP, 21 CFR Part 11, USP 1120, EP 2.2.48
  • Swappable, rechargeable batteries for continuous operation
  • Proprietary data processing, advanced fluorescence-rejection
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