cGMP Raw Material Verification – Progeny by Rigaku

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cGMP Raw Material Verification – Progeny by Rigaku

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cGMP Raw Material Verification – Progeny by Rigaku

With the push towards 100% raw material inspection, Progeny enables users to  make immediate decisions with fast and simple PASS/FAIL results. APIs and Excipients are analysed in seconds without opening packaging helping thereby never exposing personnel or product to contamination.

Progeny is the latest generation handheld Raman spectrometer, specifically designed for regulated Pharmaceutical and Life Science industries. Easy to use by QC or non-QC staff for enhanced lean manufacturing quality assurance, quality control, counterfeit pharmaceutical screening, and other applications.

Data Integrity, Electronic Signature review/approval, full 21CFR part11 compliance plus simple validation work-flow are just some of the features of Progeny.
Progeny further facilitates regulatory compliance by providing a comprehensive IQ/OQ/PQ package plus integrated camera for barcode reading to ensure error free data entry.

Progeny is an FDA 1040, USP, EP, MHRA GMP approved technique. Contact us today to request our Progeny Statement of Regulatory Compliance.

Progeny successfully overcomes sample-induced fluorescence interference with the use of a unique 1064nm excitation laser for expanded positive material identification. Varying moisture content and particle size is not an issue either. Progeny handheld Raman spectrometer delivers the industry’s widest and most comprehensive range of raw material identification and finished pharmaceutical product authentication in a handheld, dedicated for GMP sealed platform.

Click here to download the Progeny Raman Brochure

Click here to download the Progeny Raman Spec Sheet

Click here to watch the Progeny Raman video

Click here to download the Cell Culture Media Identification Using Raman Analysis Application Note

Lean cGMP  Raw Material Verification 

  • Little to no sample preparation
  • Non-destructive analysis
  • No chemical consumables or disposal hassle

The globalisation of the pharmaceutical supply chain and push towards 100% material inspection has led to a significant increase in the demand for cost effective, efficient and regulatory compliant methods for raw material identification (RMID) and chemical verification. Strict quality assurance and quality control measures are more important than ever to ensuring the safety and efficacy of products before reaching consumers.

Traditional workflows involve sending samples to external laboratories for analysis. However, this can result in additional costs and time delays. By implementing a raw material identification method that offers ease of use, a comprehensive range of sampling capabilities and rapid, customisable software at the point of need, a lean manufacturing process can be achieved.

Pharmaceutical manufacturers can now achieve 100% raw material identification, verify chemicals and solvents, as well as authenticate final products quickly and confidently. Using Progeny 1064nm handheld Raman, users can achieve Good Manufacturing Practices and comply with 21 CFR Part 11.

Raman spectroscopy is now recognised by the U.S. Pharmacopoeia and the European Pharmacopeia for raw material identification.

Progeny Raw Material Identification Solution

Progeny 1064nm handheld Raman spectrometer broadens the analysis range for pharmaceutical, biopharmaceutical, nutraceutical, and cosmetic raw materials; enabling manufacturers to achieve positive material identification outside the lab, inside the lab or anywhere rapid lab-quality analysis is needed. Progeny offers unique benefits that until now have not been delivered:

  • Eliminates sample interference – fluorescence or moisture
  • User adjustable focus ensures materials’ analysis, not the packaging
  • User customisable analysis settings
  • Truly compliant 21 CFR Part 11 digital signatures

 Ergonomics

Flexibility for use throughout the manufacturing process and beyond. Materials’ analysis using one device on the warehouse dock, in the holding area or clean room, within the laboratory, at-line, post process, pre-dispensing from the warehouse or in the field is now a reality. Progeny features include a smart-phone inspired user interface, with analysis initiation and navigation via the touchscreen display or large buttons. The sleek design delivers truly one-handed operation. Tested and certified rugged to military MIL-STD 810G & IP-68 requirements.

Learn more about how Progeny is different

 

See how Progeny can improve efficiency

 

Click here to download the Progeny Raman Brochure 

Click here to download the Progeny Raman Spec Sheet

Click here to download the Cell Culture Media Identification Using Raman Analysis Application Note

 

Call us on 051 392 391 with your instrument problems and we will recommend a solution - advice is FREE!