Engineering challenges in pharma and biomedicine
The pharmaceutical industry is one of the largest users of optical analytics. NIR and Raman spectroscopy are used for quality control of raw materials and finished products, checking blend homogeneity, and detecting adulteration. UV-Vis systems are used for quantitative API (Active Pharmaceutical Ingredient) analysis. Flow cytometry and fluorescence microscopy support biological process control.
Designing optical analytical systems requires precise modeling of radiation propagation through the sample, collection optics, and detector. Uneven sample illumination or unavoidable stray light in the measurement chamber can distort results — and become a source of costly errors in the manufacturing process.
How does our software support design?
| Product | Role in this area |
|---|---|
 | Illumination systems for spectroscopy, UV disinfection, optical microfluidics, tissue optics |
 | Fiber-optic spectroscopic interrogation systems, FBG signal analysis in processes |
 | Cell-imaging microscopes, collection systems for spectrometers |
a UV-C disinfection system for a production line
Design assumptions
A UV-C disinfection chamber for a 20 m production line had to ensure a minimum radiation dose exceeding 40 mJ/cm² across the entire surface of every product being transported, in line with Good Manufacturing Practice (GMP) requirements.
Optical model of the chamber
A model of the chamber was developed in TracePro, covering the UV-C radiation sources, reflectors, and the geometry of the transported product. An analysis of radiant intensity distribution and cumulative dose was carried out across all product surfaces as it moved through the chamber.
Eliminating dead zones
The simulations revealed shadowed areas behind the conveyor's structural elements, where the dose achieved was insufficient. After adding side radiation sources and optimizing the reflector geometry, a uniform dose distribution was achieved, eliminating dead zones and ensuring the required minimum dose across the entire product surface.
Design verification
The verified model allowed the number and placement of UV-C sources and the reflector geometry to be determined before building a prototype, reducing the number of costly experimental tests and the risk of failing to meet disinfection process requirements.
Frequently asked questions
Pharma and biomedicine
Does TracePro support the UV-C range (200–280 nm)?
Yes. TracePro supports simulations across the full UV range (100–400 nm), accounting for the properties of optical materials, coatings, and housing materials for this spectral range.
Can a microfluidic channel with optical detection be simulated?
Yes. TracePro can model light propagation through thin microfluidic channels containing a biological fluid, analyzing fluorescence excitation efficiency and signal collection efficiency by the detection optics.
Does the software support validation documentation (IQ/OQ/PQ)?
TracePro and OSLO simulations can be part of the Design Verification documentation in the validation process for medical and analytical devices. Our engineer will discuss the details of using simulation results in GMP documentation.
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