Automated PAT
NIR lyo defect inspection
SPECTRA NIV
NIR spectroscopy provides multiple advantages over wet chemical analysis methods such as Karl Fischer titration. NIR spectroscopy is a non-destructive process analytical technology that allows real time testing at production speeds.
Our SPECTRA NIV is an inspection platform for lyophilized products. It uses a high speed near infrared spectrometer that allows 100% inspection of lyophilized products at production speeds of up to 600/min.
High-speed
The NIR module can generate and analyze up to 600 spectra per minute and allows the integration into high-speed production lines.
Verification system
Automated positioning of reference standards onto the NIR station allows the operation of the system without user intervention.
Adjustable for various vial sizes
Fast and easy change
The SPECTRA NIV 300 is a high speed inspection platform for the non-destructive acquisition and analysis of NIR spectra of lyophilized products. NIR spectroscopy allows the determination of multiple parameters simultaneously such as moisture concentration, defects of the lyophilizate and the identification of the product.
Once the method is developed and validated the system does not require human intervention as the analysis, as well as the system verification, is done fully automatically and is easy to use. The NIR data gives the same reliability which is comparable to the reference analytic methods (e.g. Karl Fischer Titration, HPLC).
System suitability tests are performed with the correct reference materials, such as wavelength standards and diffuse reflection standards, that are traceable to National Institute of Standards and Technology (NIST). Along with the inspection platform, we offer the full method development and validation.
Features
- Testing speed up to 600 vials per minute
- Applicable for lyophilized vials from 2ml – 100ml
- 100% spectrometric analysis of lyo defects
- Non-destructive testing allows 100% control
- No preparation of samples required
- Fully integrated in PLC and HMI system
- Automated system verification test
- Reference standards according to NIST
- Reliable product handling
- Design according GMP guidelines
- Data Handling in compliance with 21 CFR part 11
- Easy format changeover
- Optional integration with other inspection technologies
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