Pharma & PAT
Spectroscopy-based Process Analytical Technology for pharmaceutical QC, method development and in-line process monitoring.
Why Pharma QC Needs a Better Approach
Traditional laboratory methods create bottlenecks at every stage of pharmaceutical manufacturing. Spectroscopy addresses them where they occur.
48-Hour Lab Bottlenecks
Incoming raw material release is delayed by slow laboratory turnaround. NIR identity testing delivers a result in seconds at the point of receipt.
Destructive Moisture Testing
Karl Fischer titration is slow, consumes solvent and destroys the sample. NIR moisture prediction is instant, non-destructive and reagent-free.
Blend Uniformity Uncertainty
Without in-process monitoring, blend endpoint is estimated by time or visual inspection — introducing batch failure risk that costs time and product.
Warehouse Release Delays
Components held pending identity verification slow production scheduling. NIR screening through sealed containers reduces the wait.
Batch Failure Risk
Without real-time process data, problems in blending, drying or granulation are only discovered after the batch is complete — when recovery costs are high.
High Per-Test Cost
Repetitive laboratory testing at every stage is expensive and scales poorly. Spectroscopy replaces many tests with a single continuous measurement.
A Three-Tier Engagement Model
Our staged approach builds trust and regulatory alignment progressively — starting fast and scaling to full PAT integration at your pace.
Tier 1 — Warehouse QC
Fast. Low risk. High immediate value.
Raw material identity screening at the warehouse door using NIR or Raman. Through-container testing eliminates destructive sampling and waiting for lab results before incoming release.
Key application: Raw material ID through opaque packaging
Tier 2 — Method Validation
Medium term. Regulatory alignment.
NIR method development validated against established reference methods — moisture vs Karl Fischer titration, content uniformity or similar. Full method validation documentation provided.
Key application: NIR moisture vs Karl Fischer titration
Tier 3 — Full PAT
Strategic. Process transformation.
Real-time in-line spectroscopy integrated into manufacturing. Blend uniformity monitoring, solvent tracking across the batch lifecycle — preventing failures before they occur.
Key application: Real-time powder blend monitoring
Why start with Tier 1?
Warehouse QC delivers immediate, measurable ROI with minimal regulatory complexity. It builds familiarity with IDIR’s instruments, models and documentation — creating the foundation of trust that makes Tier 2 and 3 engagements faster and lower risk.
Validation Documentation
IDIR produces structured documentation to support regulated validation workflows across pharmaceutical manufacturing environments.
IQ/OQ/PQ Compatible
Documentation structured to align with Installation Qualification, Operational Qualification and Performance Qualification frameworks — supporting your validation team's requirements.
Method Validation Reports
Reference-method comparison data, model accuracy statistics (RMSEC, RMSECV, RMSEP, R²), bias, linearity and selectivity — in report formats suitable for inclusion in regulated quality files.
Calibration Documentation
Full calibration dataset records including sample traceability, reference method data, preprocessing steps and model parameter documentation for audit and review.
Documentation formats are tailored to client requirements. Contact us early in scoping to align outputs with your specific quality system needs.
Why IDIR for Pharma
Spectroscopy vendors are common. Validated, hardware-neutral PAT partners with deep chemometrics expertise are not.
Hardware Neutral
We work with your existing benchtop NIR or Raman instrument. No requirement to purchase IDIR hardware — we optimise what you already have.
Reference Method Backed
Every spectroscopic model is calibrated against verified reference laboratory data. Results are traceable and defensible — not black-box predictions.
Deep Chemometrics Expertise
IDIR's team includes Imperial College London PhDs with decades of combined published research in applied chemometrics and industrial spectroscopy.
Pharma Applications in Development
These applications are currently being developed into full case studies. Contact us to discuss any of them for your facility.
Raw Material ID Through Packaging
NIR/Raman identity verification of incoming pharmaceutical materials through sealed containers — no sampling, no lab wait.
View on Case Studies →NIR Moisture vs Karl Fischer
Non-destructive moisture prediction as an alternative to KF titration — validated against pharmaceutical reference standards.
View on Case Studies →Real-Time Blend Uniformity
In-line NIR monitoring during pharmaceutical powder blending — detecting blend endpoints and preventing batch failure from non-uniformity.
View on Case Studies →Start with a Pharma Feasibility Review
Tell us your application — material type, parameter, existing method. We’ll assess whether NIR or Raman can solve it and outline a validation path.