Why Endress+Hauser for real-time release testing (RTRT)

Real-Time Release Testing (RTRT) replaces reactive quality checkpoints with continuous, in-process verification of Critical Quality Attributes (CQAs). To make RTRT practical under current Good Manufacturing Practice (cGMP) conditions, manufacturers need Process Analytical Technology (PAT) that is robust in real production environments and scalable from lab to plant.

In practice, this requires analytical sensors and spectroscopic analyzers to be mechanically, digitally and procedurally integrated directly into process equipment from development through commercial manufacturing.

Endress+Hauser provides this with an integrated inline measurement portfolio centered on Raman spectroscopy – and strengthened by a reliable digital sensor infrastructure for Critical Process Parameters (CPP) monitoring.

PAT is an FDA framework for designing, analyzing and controlling manufacturing through timely measurements of CPPs and CQAs. Instead of relying on end-product testing alone, PAT embeds analytical intelligence into the process to enable:

• Inline and at-line analytics (e.g., Raman spectroscopy)
• Sensors for core process variables (pH, conductivity, dissolved oxygen)
• Multivariate models and chemometrics
• Automated monitoring, trending and (where applicable) feedback control

Raman spectroscopy is highly suited to pharmaceutical and biopharmaceutical processes because it delivers rich process information without destructive sampling. The technology illuminates the sample with a laser. A small portion of scattered light shifts in wavelength (the “Raman shift”) based on molecular vibrations. This shifted signal forms a unique spectral fingerprint.

With appropriate calibration models, Raman can quantify concentrations and track composition changes continuously.

In upstream bioprocessing, Raman technology can be used to monitor glucose and metabolites, helping teams optimize feeding strategies, maintain consistent culture conditions, and reduce variability. In practice, Raman enables RTRT when it is implemented as part of a validated measurement and automation strategy, with appropriate model governance, engineering design, and ongoing performance verification.

Endress+Hauser Raman systems are designed to deliver continuous, real-time process information without extracting, preparing or destroying the native sample.

Our Raman Rxn2 and Raman Rxn4 analyzers support PAT deployment where stability and consistent measurement performance are essential.

Endress+Hauser’s Raman probe suite supports a range of installation needs, helping teams bring the same core measurement method from development rigs to pilot and commercial equipment, including different vessel types and port configurations.

Endress+Hauser emphasizes user-friendly, automation-compatible software, which reduces friction during implementation. RTRT success depends not only on spectral quality, but on model lifecycle management, change control readiness and dependable support when processes evolve.

Raman technology is powerful, but RTRT requires the whole measurement ecosystem to be dependable. Endress+Hauser strengthens Raman-based PAT with an inline instrumentation foundation designed for high availability and data integrity.

From an operations perspective, modern Raman spectroscopy systems are designed for low routine maintenance, with stable optical performance and no consumables or destructive sampling. This helps reduce the ongoing support burden compared with frequent off‑line testing or high-touch analytical methods.

For automation teams, Raman measurements can be integrated into standard control and monitoring architectures, allowing spectral outputs and model results to be trended, alarmed, and contextualized alongside traditional process variables in the DCS. This supports consistent operation and validated use under GMP change control.

While Raman targets composition and concentration, robust RTRT strategies also rely on stable measurement of CPPs. Endress+Hauser’s Memosens 2.0 digital technology modernizes liquid analysis by converting measured values to digital signals inside the sensor and transmitting it inductively

In real-world operations, the solution provides:

• Moisture-resistant, corrosion-resistant connections: inductive, non-contact transmission avoids common failures caused by humidity
• Electromagnetic compatibility safety and interference-free signals: galvanic isolation ensures reliable measurement in challenging industrial environments
• Plug-and-play with pre-calibrated sensors enables fast sensor swap-out to reduce downtime
• More data for traceability and predictive maintenance: Memosens 2.0 provides significantly more calibration and historic sensor data, supporting trending, maintenance planning and industrial internet of things (IoT) readiness.

In cGMP-regulated environments, especially at scale, the dependability of Memosens sensors helps eliminate deviations, supports stable automation and help standardization of measurement technologies across sites.

While Raman targets composition and concentration, robust RTRT strategies also rely on stable measurement of CPPs. Endress+Hauser’s Memosens 2.0 digital technology modernizes liquid analysis by converting measured values to digital signals inside the sensor and transmitting it inductively

In real-world operations, the solution provides:

• Moisture-resistant, corrosion-resistant connections: inductive, non-contact transmission avoids common failures caused by humidity
• Electromagnetic compatibility safety and interference-free signals: galvanic isolation ensures reliable measurement in challenging industrial environments
• Plug-and-play with pre-calibrated sensors enables fast sensor swap-out to reduce downtime
• More data for traceability and predictive maintenance: Memosens 2.0 provides significantly more calibration and historic sensor data, supporting trending, maintenance planning and industrial internet of things (IoT) readiness.

In cGMP-regulated environments, especially at scale, the dependability of Memosens sensors helps eliminate deviations, supports stable automation and help standardization of measurement technologies across sites.

For teams implementing PAT to unlock RTRT, Endress+Hauser’s Raman-centric portfolio is designed to produce outcomes that accelerate speed, reduce cost and mitigate risk:

• Faster release decisions: reduced batch hold times by moving quality verification upstream
• Earlier deviation detection: real-time insight helps prevent drift from becoming a batch failure
• Improved process understanding: high-frequency Raman data supports stronger CPP-CQA relationships and more confident design space definition
• Scalable analytics: consistent Raman measurement approach from lab through commercial supports smoother tech transfer
• A path to Biopharma 4.0: inline Raman plus digital sensor data supports advanced monitoring, trending, and process optimization programs

RTRT is an achievable operating model. Endress+Hauser helps manufacturers operationalize RTRT by pairing industrial Raman spectroscopy systems with Memosens 2.0 digital sensor technology for future-proof liquid analysis and CPP visibility.

With more than 40 years of experience, the depth and breadth of our portfolio allow our customers to gain molecular insights to help streamline product development, provide analytical scalability and ensure product quality through process automation.