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.

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.

Advanced Performance

  • 1064nm laser excitation to minimize fluorescence interference
  • Spectral resolution 8-11cm-1 reveals minor differences in similar material
  • Spectral range 200-2500cm-1 covers the most relevant molecular spectral features
  • Transmissive volume phase grating design for years of alignment-free operation
  • TE cooled InGaAS 512 pixel detector for high resolution results

User Control

  • 30-490 mW adjustable laser power in 5 mW increments to optimize analysis
  • 5ms to 30s adjustable exposure time in 5ms increments for more accurate results
  • Adjustable focus nose cone to ensure analysis of materials through packaging

CompleteID Software

  • Administrator created workflow methods specific to material ensures accurate analysis
  • Rapid addition of new materials to your custom on-board library
  • Truly 21 CFR Part 11 compliant digital signatures
  • On-board barcode scanner for error-free sample information entry

Sophisticated Ergonomics

  • Optimal for one-handed operation: 29.9cm x 8.1cm x 7.4cm (11.8in x 3.2in x 2.9in) and weighing ~1.5kg (3.5lbs)
  • IP-68 rated ruggedized aluminum housing for maximum durability and minimization of cross-contamination
  • Large high resolution screen allows for high visibility in confined spaces and outdoors
  • Choice of user interface:
  • Smartphone-inspired touchscreen provides fast learning-curve
  • Softkey buttons for one-handed operation while wearing protective gloves

Unique Accessories

  • Docking station for easy data transfer to LIMS or Server
  • Adjustable focus vial adapter to accommodate your different vial sizes
  • Tablet adapter to accommodate different sized tablets and other sample types for increased flexibility

Additional Services

  • IQOQPQ document and on-site validation services
  • Performance qualification and recertification services
  • Raw Material Identification Standard Operating Procedures documentation

Other Specifications

  • Certifications: FDA 1040, 21 CFR, CE, ISO 9001:2008 Certified Manufacturing facility
  • External battery charger: 100~240VAC
  • Operating temperature of 20 to 50oC
  • Warranty of 24 months

Click Here to download the Progeny Raman Brochure 

Click Here to download the Progeny Raman Spec Sheet

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

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Process Monitoring – MicroNIR 

Process Monitoring – Hyperflux PRO Plus Raman

Higher Raman Sensitivity Than Ever Before Possible

The HyperFlux PRO Plus redefines what is possible with process measurements using the power of Raman spectroscopy. The newly re-designed HTVS component enhances the spectral throughput by an order of magnitude over conventional designs providing superior photon management. This allows process measurements to be done faster and with better sensitivity.

  • More accurate identification and quantitation
  • Faster measurement
  • Lower laser power operation
  • Flexible chemometric options including Unscrambler, Simca-P+, Pirouette,  Eigenvector.
  • 21CFR11 and IQOQPQ option for GMP applications.
  • 8-channel multiplex option.
  • ATEX option available with OPIS35

Hyperflux PRO Plus -  HTVS Raman Spectrometer

ATEX rated. On-line/In line and Reaction monitoring

Tornado’s HyperFlux PRO Plus is a complete Raman spectroscopy system including a proprietary HTVS-enabled spectrometer, a high-quality stabilised laser, multiple laser safety interlocks, temperature monitoring and dynamic re-calibration, and automated system health monitoring and fault detection. This powerful, reliable, and easy-to-use instrument is contained in a small, lightweight, cost-effective package which is readily deployed in both in-line process and laboratory settings.

The HyperFlux PRO Plus redefines what is possible with process measurements using the power of Raman spectroscopy. The newly re-designed HTVS component enhances the spectral throughput by an order of magnitude over conventional designs providing superior photon management. This allows process measurements to be done faster and with better sensitivity. The HyperFlux PRO Plus is perfect for ATEX situations where the highest sensitivity is required. Put Raman to work in your process measurement scheme.

The HyperFlux PRO Plus offers customisable bandpass, resolution, and throughput configuration delivering high-performance with versatility to meet your application requirements:

  • 4 cm-1 spectral resolution with no slit
  • Configurable for a variety of applications
  • Stand-off and immersion probe optics
  • No moving parts for superior stability

High signal throughput allows:  Faster measurements, better detection limits, reduced laser power to preserve samples and the potential for use of anti-stokes signal.

Proven real world applications:

  • Monitoring of polymer curing processes
  • Following crystalisation (crystalization) processes
  • Monitoring extrusion processes
  • Optimisation of chemical reactions in manufacturing
  • Real-time detection of process anomalies and excursions
  • Analysis of fuel mixtures

Plus many other examples... 

 

 

SPECIFICATIONS:

Laser 785 nm
Laser Power 20mW to 475 mW
Bandpass Configurable to Measurement Requirements
Probes Immersion and Non-Contact
Unit size and weight 18.4 x 8.5 x 5.4 inches, 22 lbs
(46.7 x 21.6 x 13.7 cm, 9.9 kg)
Input power requirements 100/240V AC line power @ 15A
Temperature limits 0 to 35°C, 20-80% humidity (non condensing)
Fiber Length up to 3 meters standard
longer lengths can be fabricated upon request.
Number of Channels 8 (with serial multiplexer)
Computer and OS requirements Windows 7, 2 GHz dual-core with
4 Gb RAM, 250 Gb HD, and USB2.0
Software Process communications options

https://vimeo.com/246834650

Click Here to download the Hyper Flux PRO Information Sheet

Click to view  SpectralSoft software Spec. Sheet

Click to view ‘Quantitative analysis of Biochemical Components’ Application Note

Click to view Application Note: ‘Focus on Spectroscopy – High Throughput Virtual Slit (HTVS) Design Addresses the Trade-off between Resolution and Throughput in Raman Spectrometers’

Home > cGMP Raw Material Verification – Progeny by Rigaku

Location: IRELAND

Unit 21, Waterford Business Park,

Cork Road, Waterford

Ireland, X91 P224

Tel: +353 (0)51 392 391

E-mail: info@antech.ie

Contact: UK

Tel: +44 (0)20 346 898 13

E-mail: info@antechsolutions.co.uk

Web: www.antechsolutions.co.uk