PendoTECH MAT Pressure Monitoring and Transmission System 19406-xx

Overview

The PendoTECH MAT Pressure Monitoring and Transmission System (Model 19406-xx) is an engineered solution for real-time, high-integrity pressure monitoring in single-use bioprocessing applications. Designed specifically for integration into aseptic fluidic systems, the system combines a modular analog/digital monitoring unit (MAT) with sterilizable, USP Class VI-compliant disposable pressure sensors. It operates on the principle of piezoresistive sensing, delivering stable, drift-compensated pressure readings across dynamic and static process conditions—including tangential flow filtration (TFF), crossflow filtration, depth filtration, bioreactor headspace and feed line monitoring, and chromatography column inlet/outlet pressure control. The system supports both regulatory-compliant operation and operational flexibility, with configurable alarm thresholds, dual-unit display capability (psi, with bar conversion available upon request), and compliance-ready signal outputs suitable for supervisory control and data acquisition (SCADA) or distributed control systems (DCS).

Key Features

• Modular MAT monitor units with scalable channel configurations: 1–4 sensor inputs (models 19406-00 through 19406-08), supporting mixed relay and analog (4–20 mA or 0–10 V) outputs per channel
• High-accuracy pressure measurement: ±0.1% full-scale (FS) repeatability under calibrated conditions; LED backlit 8-line alphanumeric display for local readout and configuration
• Wide input power range: 12–24 V DC, enabling compatibility with standard industrial power supplies and battery-backed control cabinets
• FDA-registered and ISO 13485-certified sensor manufacturing in ISO Class 8 (formerly Class 100,000) cleanrooms
• USP Class VI-compliant sensor housings constructed from gamma-stable polycarbonate or corrosion-resistant polysulfone—validated for repeated gamma irradiation up to 50 kGy without performance degradation
• No dead-leg design: fully flush, zero-holdup fluid path ensures compatibility with CIP/SIP protocols and eliminates risk of microbial entrapment or carryover
• Pre-tested for hermeticity and calibration traceability: each sensor undergoes individual leak testing (≤1 × 10⁻⁹ mbar·L/s He) and factory calibration with NIST-traceable standards

Sample Compatibility & Compliance

The MAT system is validated for use with single-use bioprocess assemblies including tubing manifolds, filter cassettes, bioreactor bags, and chromatography skids. Sensor wetted materials are compatible with aqueous buffers, cell culture media, sanitizing agents (e.g., NaOH, phosphoric acid), and common excipients. Non-wetted electronics remain external to the sterile boundary, satisfying ISO 13485 design control requirements. All system documentation—including calibration certificates, material declarations, and biocompatibility reports (ISO 10993-5/-10/-12)—is provided per batch. The system supports audit readiness for FDA 21 CFR Part 11 (when integrated with compliant SCADA software), EU Annex 11, and ICH Q5A/Q5D for viral clearance validation workflows.

Software & Data Management

While the MAT hardware operates as a standalone analog/digital transmitter, it is fully interoperable with third-party process automation platforms via its 4–20 mA or 0–10 V analog outputs and dry-contact relay signals. For digital integration, optional RS-485 Modbus RTU interface modules (sold separately) enable direct communication with LabVIEW, DeltaV, or Siemens PCS7 systems. Alarm setpoints (high/low limits) are configured locally via front-panel navigation or remotely via analog input scaling. All configuration changes are logged internally with timestamped event records, supporting GLP/GMP traceability when paired with a validated electronic logbook. Firmware updates follow controlled change management procedures aligned with IEC 62304 Class B software lifecycle requirements.

Applications

• Tangential flow filtration (TFF) transmembrane pressure (TMP) and feed line pressure monitoring during buffer exchange and concentration
• Bioreactor sparging and headspace pressure control in single-use stirred-tank reactors (SUBs)
• Chromatography system line pressure verification pre- and post-column to detect resin compaction or blockage
• Depth filter integrity testing and differential pressure trending during clarification campaigns
• Fill-finish line pressure profiling for vial/bag filling accuracy and sterility assurance
• Process analytical technology (PAT) deployments requiring continuous, non-invasive pressure feedback for model-based control strategies

FAQ

Can the disposable pressure sensors be reused after gamma sterilization?
Yes — all sensors are qualified for ≥3 cycles of 25–50 kGy gamma irradiation without measurable drift or housing deformation.
Is the MAT unit suitable for hazardous area installations?
No — the MAT monitor is rated for general-purpose indoor use (IEC 60529 IP20). For Class I Div 1 environments, consult PendoTECH’s intrinsically safe signal isolator options.
What is the maximum cable length between sensor and MAT unit?
Standard shielded cables support up to 3.66 m (12 ft); extended-length custom cables (up to 10 m) are available with impedance-matched compensation.
Do you provide calibration certificates with NIST traceability?
Yes — each sensor ships with a unique calibration report referencing NIST-traceable primary standards; annual recalibration services are offered under ISO/IEC 17025 accreditation.
How is sensor accuracy maintained across temperature fluctuations?
Sensors incorporate onboard temperature compensation algorithms; MAT firmware applies second-order thermal correction using integrated ambient temperature sensing.