PendoTech Model 19406-00 Pressure Monitor
| Origin | USA |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model Number | 19406-00 |
| Pricing | Available Upon Request |
Overview
The PendoTech Model 19406-00 Pressure Monitor is a high-integrity, FDA-compliant pressure sensing system engineered for real-time, non-invasive monitoring of fluid pressure in single-use bioprocessing applications. Designed specifically for use with PendoTech’s proprietary sterile, disposable sensor sleeves—installed directly onto standard tubing or bag ports—the device operates on the principle of capacitive pressure transduction, delivering stable, drift-free analog and digital output without requiring process fluid contact with internal electronics. Its architecture supports continuous operation across temperature ranges from 4 °C to 40 °C and pressures up to 30 psi (207 kPa), making it suitable for upstream and downstream unit operations including bioreactor harvest, buffer delivery, filtration, and chromatography skid monitoring.
Key Features
- Capacitive-based pressure sensing technology ensures long-term signal stability and eliminates zero drift commonly associated with piezoresistive elements.
- Non-invasive design: sensor sleeve remains external to the fluid path, preserving sterility and eliminating risk of leachables or extractables—critical for cGMP biomanufacturing environments.
- Integrated analog (0–5 V or 4–20 mA) and digital (RS-485 Modbus RTU) outputs enable seamless integration with PLCs, SCADA systems, and DCS platforms.
- IP65-rated enclosure provides protection against dust ingress and low-pressure water jets, supporting deployment in controlled manufacturing suites and cleanroom-adjacent utility corridors.
- Calibration traceable to NIST standards; factory calibration certificate included with each unit; field verification supported via external reference pressure source.
- Configurable alarm thresholds with relay output for immediate process interlock activation upon overpressure or underpressure events.
Sample Compatibility & Compliance
The Model 19406-00 is validated for use with silicone, thermoplastic elastomer (TPE), and polyvinyl chloride (PVC) tubing in diameters ranging from 1/4″ to 1/2″ (6.4–12.7 mm), as well as with PendoTech-compatible single-use bioprocess bags (e.g., Sartorius BPS, Thermo Fisher HyPerforma, GE Flexsafe). It complies with IEC 61000-6-2 (immunity) and IEC 61000-6-4 (emissions) for industrial environments. The system meets relevant sections of ISO 13485:2016 for medical device quality management systems and supports alignment with FDA 21 CFR Part 11 requirements when used with validated data acquisition software that implements electronic signatures, audit trails, and user access controls.
Software & Data Management
While the 19406-00 operates as a standalone analog/digital transmitter, it is fully compatible with PendoTech’s PendoSoft™ Suite (v3.2+), a Windows-based application enabling real-time visualization, configurable logging intervals (100 ms to 10 s), trend analysis, and CSV/PDF report generation. All logged data includes timestamped metadata (device ID, firmware version, calibration date), satisfying GLP and GMP documentation expectations. When integrated into enterprise MES or historian systems (e.g., Siemens Desigo CC, Rockwell FactoryTalk Historian), the device supports time-synchronized data ingestion with millisecond-level precision via Modbus TCP gateways.
Applications
- Continuous pressure monitoring during tangential flow filtration (TFF) to prevent membrane compaction or module rupture.
- Real-time detection of pump occlusion or line blockage in peristaltic and diaphragm pump circuits.
- Verification of pressure integrity during pre-use post-sterilization (PUPSIT) testing of single-use assemblies.
- Monitoring of fill/empty cycles in single-use bioreactors and storage bags to ensure consistent headspace control.
- Integration into automated process analytical technology (PAT) frameworks for Quality by Design (QbD) initiatives per ICH Q8(R2).
FAQ
Is the Model 19406-00 suitable for steam-in-place (SIP) or autoclave sterilization?
No—the sensor sleeve and monitor electronics are not rated for direct exposure to saturated steam or autoclave conditions. Sterilization is achieved via gamma irradiation of the disposable sleeve prior to installation.
Can multiple 19406-00 units be daisy-chained on a single RS-485 bus?
Yes—up to 32 devices may be addressed uniquely on one Modbus RTU network using configurable node IDs.
What is the recommended recalibration interval under routine GMP use?
PendoTech recommends annual calibration verification; however, user-defined risk assessments per ASTM E2500 may justify extended intervals based on historical performance data and change control records.
Does the device support HART communication protocol?
No—only analog (0–5 V / 4–20 mA) and RS-485 Modbus RTU interfaces are supported.
Is firmware upgrade capability available in the field?
Yes—firmware updates are performed via USB-to-serial adapter using PendoSoft™ Utility, with full version rollback and checksum validation.
