PendoTECH PREPS-N-050 Single-Use Pressure Sensor (Model 19406-03)

Overview

The PendoTECH PREPS-N-050 Single-Use Pressure Sensor (Model 19406-03) is a high-integrity, disposable pressure transduction component engineered for bioprocessing, single-use systems (SUS), and sterile fluid handling applications. Designed to replace traditional stainless-steel sensors in applications where cleaning-in-place (CIP) and sterilization-in-place (SIP) are impractical or cost-prohibitive, this sensor operates on piezoresistive strain-gauge technology integrated into a molded polymer housing. It delivers real-time, dynamic pressure monitoring across process lines with zero dead-leg geometry—eliminating flow restriction and microbial harborage points. The sensor is calibrated and leak-tested to 99.99% reliability prior to release and is compatible with the PendoTECH PressureMAT™ series of monitoring and control units, enabling seamless integration into GMP-compliant manufacturing environments including upstream bioreactor feeds, downstream buffer delivery, tangential flow filtration (TFF), and chromatography skids.

Key Features

• Single-use architecture eliminates cross-contamination risk and validation burden associated with reusable sensors
• USP Class VI-certified polysulfone housing—gamma-stable, chemically resistant, and suitable for gamma sterilization (pre-sterilized variants available)
• Zero-dead-volume design with integral flow path; no internal cavities, blind ends, or gasket interfaces
• Full-scale pressure range of 0–5.3 bar (0–77 psi), optimized for low-to-medium pressure bioprocess applications
• High accuracy of ±0.1% full scale (FS) with 0.1% FS resolution, traceable to NIST standards
• 1/2″ barbed connection for direct in-line installation into standard silicone or thermoplastic elastomer (TPE) tubing
• Pre-terminated 3.6 m (12 ft) shielded cable with industry-standard connector for plug-and-play compatibility with PressureMAT™ monitors
• Manufactured in an ISO 13485-certified, FDA-registered facility under ISO Class 8 (formerly Class 100,000) cleanroom conditions

Sample Compatibility & Compliance

The PREPS-N-050 is validated for use with aqueous buffers, cell culture media, protein solutions, and low-viscosity process fluids common in mammalian and microbial biomanufacturing. Its polysulfone construction resists hydrolysis and maintains dimensional stability under repeated thermal cycling (autoclave-compatible up to 121°C for non-sterile versions). All materials comply with USP and cytotoxicity testing requirements. The device meets ISO 10993-5 biological evaluation standards and is manufactured under a quality management system aligned with ICH Q5A, Q5D, and Annex 1 (EU GMP) principles. While not individually CE-marked as an active medical device, it supports compliance with FDA 21 CFR Part 11 when used with audit-trail-enabled PressureMAT™ software (e.g., ZD-19406-70) in regulated workflows.

Software & Data Management

The PREPS-N-050 integrates natively with the PendoTECH PressureMAT™ family of controllers—including PMAT2-BAR, PMAT4A-BAR, and PMAT3P-BAR—enabling dual-channel pressure monitoring with optional flow input. Data acquisition occurs at 1 Hz per channel and is displayed on a backlit LCD with user-configurable high/low alarm thresholds. Analog output (4–20 mA) supports PLC and DCS interfacing, while RS-232 serial communication enables direct logging into third-party SCADA platforms or Excel® via WinWedge™ or custom Python/Node-RED scripts. Optional accessories include ZD-19406-82 (RS-232 to USB adapter), ZD-19406-70 (PressureMAT Data Acquisition Software with time-stamped CSV export and trend visualization), and ZD-19406-95 (benchtop mounting base for GxP-aligned instrument placement). All software modules support electronic signatures, change history, and audit trail generation per ALCOA+ principles.

Applications

• Monitoring inlet/outlet pressure in single-use bioreactors and rocking motion platforms
• Real-time pressure feedback during peristaltic pump-driven buffer exchange in purification suites
• Line pressure verification in sterile filtration trains (0.22 µm and 0.45 µm membrane filters)
• Process validation support for filling line integrity checks and vial pressurization cycles
• Leak detection and hold-test execution in closed-system transfer devices (CSTDs)
• Integration with PAT (Process Analytical Technology) frameworks for QbD-based process control

FAQ

Is the PREPS-N-050 sensor compatible with non-PendoTECH monitoring systems?
Yes—its analog 4–20 mA output and RS-232 interface allow integration with third-party PLCs, DAQ systems, or custom controllers using the ZD-19406-80 shielded cable kit.
What is the maximum recommended operating temperature?
The sensor is rated for continuous operation up to 60°C; short-term exposure to 80°C is permissible for SIP cycles when used with non-sterile variants.
Can this sensor be autoclaved?
No—autoclaving is not recommended. Sterilization must be performed via gamma irradiation (pre-sterilized PREPS variants are available); steam exposure may compromise polysulfone integrity.
Does the sensor require zero calibration before each use?
No—factory calibration is stable over shelf life (24 months from manufacture date). Zero adjustment is optional and supported via single-button function on the PressureMAT™ unit.
How is traceability maintained for regulatory submissions?
Each sensor bears a unique lot number and QC test report (including pressure calibration curve and helium leak test data), supplied digitally upon request for inclusion in Device Master Records (DMRs) and Batch Production Records (BPRs).