Are You Sure Your Pharma Process Is Under Control?

Every Stage of Pharmaceutical Manufacturing Carries Hidden Risks

Contamination

Uneven Blending

Off-Spec Coating

Don't Derail Your Batch. Your Data Integrity and Your Reputation will be at Risk.

Unlock the power of 21 CFR Part 11 Compliance software with the tec5USA Process Spectroscopy Advantage!
Experience next-level data integrity, traceability, and performance with our industry compliant software designed to meet pharmaceutical regulatory standards.

What Stage Are You In?

tec5USA can help you discover gaps in your process! Every stage of pharmaceutical manufacturing carries hidden risks — contamination, uneven blending, off-spec coating — all waiting to derail your batch, your data integrity, and your reputation.

Cleaning Validation (UV)

Challenge:

How do you know when your tank is truly clean — not just visually?

Solution:

Verify residue-free surfaces in real time with UV spectroscopy.

Mixing & Blending (NIR)

Challenge:

Is your powder blend truly uniform? Or will one bad batch destroy your yield?

Solution:

Monitor blend homogeneity instantly with inline NIR.

Granulation (NIR)

Challenge:

Is your powder the right particle size for proper compaction and dissolution?

Solution:

Track particle distribution and moisture continuously.

Tablet Compacting (NIR)

Challenge:

Are you pressing the right composition — every time?

Solution:

Control API and excipient ratios inline before compression.

Coating (Raman)

Challenge:

Too thick? Too thin? Is there enough gelatin on your capsules?

Solution:

Raman confirms coating consistency and thickness in-process.

Have a unique challenge? We can find a solution to that.

BOOK A 10 MEETING

Discover the tec5USA Advantage — From Application to Integration.

Powered by the PROGAZE^® Spectroscopy Platform

Our PROGAZE^® spectroscopy platform features configurable systems and probes for a wide range of applications and environments. Future-proof technology covering UV, VIS, NIR, and Raman with reliability, reproducibility, and scalability. Easy integration via standard interfaces and protocols.

Robust spectrometer for demanding environments:

Harsh conditions (temperature, dust, dirt, etc.)
Hygienic or corrosive environments
Explosion-protected zones

Easy to integrate 19″ compatible spectrometer system:

Fits into standard 19″ cabinets or as table-top
Extendable with 19” multiplexers, IPCs, displays, etc.
Flexible front/rear mounting options

Standardized assemblies for direct integration:

Fully functional, CE-tested spectrometer
High vibration and temperature tolerance
Numerous configuration and installation options

With the tec5USA Process Spectroscopy Advantage, you get certainty—not guesswork.

Our UV-VIS, NIR, and Raman analyzers, including 3-A sanitary probes, ATR Flow Cells, and Micro Transmission Probes, integrate seamlessly with our 21 CFR Part 11 compliant software to give you real-time insight and defensible audit trails across your entire process. Contact us to learn more about:

EXPLORE UV-VIS SOLUTIONS

EXPLORE NIR ANALYZERS

EXPLORE RAMAN SOLUTIONS

Learn the Top 7 Reasons Pharma Leaders are Rethinking Process Control with Inline Spectroscopy

Unlock 21 CFR Part 11 compliance for PAT data

Turn spectroscopy outputs into legally defensible electronic records with validated systems, role-based access, audit trails, and e-signatures.

Close common FDA inspection gaps (before they’re found)

Eliminate risky practices like uncontrolled CSV exports, shared logins, missing audit trails, and non-compliant data storage that can undermine batch-release decisions.

Real-time control across critical unit operations

Deploy inline UV-VIS, NIR, and Raman at high-impact steps—Cleaning Validation, Blending, Granulation, Tablet Compacting, and Coating—to monitor CQAs continuously.

Integrated hardware built for pharma environments

Use hygienic, process-ready measurement interfaces (e.g., 3-A sanitary probes, ATR Flow Cells, Micro Transmission Probes) designed for real plant conditions.

End-to-end traceability from sensor to decision

Securely link spectra, predictions, batch IDs, process parameters, and operator actions into an auditable architecture that supports QA, validation, and inspections.

A practical roadmap to scale compliant inline analytics

Start with a high-value pilot, define URS and integration needs (DCS/MES/historian), validate workflows, then replicate across processes and sites with controlled model lifecycle management.

Are You Sure
Your Pharma Process is Under Control?

Every Stage of Pharmaceutical Manufacturing Carries Hidden Risks

Don't Derail Your Batch. Your Data Integrity and Your Reputation will be at Risk.