Lean cGMP  Raw Material Verification 

• Little to no sample preparation
  
• Non-destructive analysis
• Analyse without opening packaging
• No chemical consumables or disposal costs

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 Raman is an FDA 1040, USP, EP, MHRA, HPRA accepted technique and our team is available to address any inquiries or provide our Progeny Statements of Regulatory Compliance upon request.

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.

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.

1. Faster scanning speeds for all materials
2. Reduced fluorescence: 1064nm laser allows analysis of a much broader range of materials including, coloured materials (and coloured packaging), Polysorbates, cell cultures plus much much more
3. E-signature: Review, Approve, Reject and sign electronically with full 21 CFR Part 11 compliance.
4. Dual-purpose docking station:

a. provides seamless data transfer to your network, LIMS or other data storage location
b. transforms the handheld device into a benchtop spectrometer
c. charger function allows for uninterrupted operation

5. WiFi or USB connectivity
6. Smart phone inspired touch screen interface
7. Integrated digital camera and barcode reader
8. MCC, Hypromellose, Croscaramellose, Hydroxypropyl Methylcellulose and other cellulose materials are now possible to identify
9. Calcium Hydrogen Phosphate possible
10. Improved data integrity and audit trails
11. Fully ruggedised and certified to military MIL-STD-810G plus IP-68 standards
12. Batch reports generated automatically
13. No moving parts or consumables
14. Dedicated SOP Word templates for method creation and validation
15. Improved cGMP compliance
16. Integrated software providing advanced analysis features that streamline processes

• Customisable settings
• User permission levels
• Batch mode
• Multiple scans per container e.g. top, middle and bottom of a single barrel
• Transfer data seamlessly and securely