testo 190-P1 CFR-Compliant Absolute Pressure Data Logger

Overview

The testo 190-P1 is a purpose-built, CFR-compliant absolute pressure data logger engineered for critical process validation and monitoring in regulated pharmaceutical manufacturing environments. It operates on piezoresistive pressure sensing technology, delivering high-fidelity, traceable absolute pressure measurements across a calibrated range of 1 mbar to 4 bar abs—covering essential operational windows for steam sterilization (autoclaving), vacuum drying, and lyophilization (freeze-drying) cycles. Its stainless steel and PEEK construction ensures mechanical integrity and chemical resistance under repeated thermal cycling, while its hermetically sealed architecture maintains full IP68 ingress protection before and after battery replacement—a requirement for validated cleanroom and sterile process applications. Designed specifically to meet the evidentiary rigor of FDA-regulated workflows, the device functions as a standalone, tamper-evident measurement node that captures time-stamped pressure events with metrological traceability.

Key Features

• CFR-compliant design validated for use in GMP environments, supporting audit-ready documentation when paired with testo 190 CFR software (21 CFR Part 11 compliant)
• High-reliability absolute pressure sensor with ±20 mbar accuracy and 1 mbar resolution, optimized for low-pressure vacuum phases and high-pressure sterilization hold periods
• Robust, compact form factor (Ø22 mm × 83 mm) enabling deployment in confined geometries—including freeze dryer shelves, autoclave chamber corners, and narrow tubing manifolds
• Tool-free, rotation-threaded battery compartment with PEEK-coated sealing interface—ensures 100% resealing integrity post-battery replacement without disassembly or calibration drift
• Extended memory capacity of 60,000 timestamped values with programmable logging intervals from 1 second to 24 hours
• Thermal resilience: continuous operation from 0 °C to 140 °C; stable storage between −20 °C and +50 °C
• Integrated lithium battery (½ AA) rated for 2,500 operating hours under typical sterilization-cycle conditions (10 s sampling at +121 °C)

Sample Compatibility & Compliance

The testo 190-P1 is intended for direct integration into validated pharmaceutical unit operations where pressure is a Critical Process Parameter (CPP). It is routinely deployed in steam-in-place (SIP) systems, depyrogenation tunnels, and lyophilizer primary drying chambers—environments demanding consistent performance under saturated steam, vacuum, and rapid thermal transients. The device conforms to IEC 60529 (IP68), carries CE marking per EU Directive 2014/30/EU (EMC) and 2014/35/EU (LVD), and—when operated with the testo 190 CFR software—supports electronic signature, audit trail, and role-based access control aligned with FDA 21 CFR Part 11, EU Annex 11, and ISO 13485 requirements. Calibration certificates are supplied with NIST-traceable uncertainty statements, and field recalibration is supported via accredited service centers.

Software & Data Management

Data acquisition, configuration, and reporting are executed exclusively through the dedicated testo 190 CFR software (sold separately), a Windows-based application developed to satisfy regulatory data integrity mandates. The software provides full lifecycle management: secure user authentication, parameter locking, real-time validation warnings during setup, automatic timestamp synchronization, and export of PDF/CSV reports with embedded metadata (device ID, calibration status, operator ID, cycle start/stop timestamps). Audit trails record all configuration changes, data reads, and report generations with immutable timestamps and user attribution. When used with the testo multifunctional docking station, up to eight 190-P1 loggers can be simultaneously programmed, read, and reset—eliminating serial handling and reducing validation protocol execution time by >60% compared to single-unit workflows.

Applications

• Steam sterilization validation (e.g., autoclave chamber mapping per ISO 17665-1 and EN 285)
• Lyophilizer chamber pressure profiling during primary and secondary drying phases
• Leak rate testing and vacuum integrity verification (e.g., helium leak testing support, ISO 15883-5)
• Depyrogenation tunnel pressure gradient analysis
• Process qualification studies requiring concurrent multi-point pressure logging
• Requalification of legacy sterilization equipment following maintenance or relocation

FAQ

Is the testo 190-P1 suitable for use inside autoclave chambers during full sterilization cycles?

Yes—the device is rated for continuous operation up to +140 °C and maintains structural and functional integrity under saturated steam conditions typical of Class B and Class S autoclaves.
Does battery replacement invalidate the device’s calibration or IP rating?

No—its patented rotary-seal mechanism ensures full resealing to IP68 specifications and preserves metrological stability without requiring recalibration.
Can the testo 190-P1 be used for vacuum-level monitoring below atmospheric pressure?

Yes—it measures absolute pressure from 1 mbar (≈0.75 Torr), making it appropriate for deep vacuum phases in lyophilization and vacuum drying processes.
Is raw data export compliant with ALCOA+ principles?

Yes—the testo 190 CFR software generates fully attributable, legible, contemporaneous, original, and accurate (ALCOA+) data files with embedded audit trails and electronic signatures.
What is the recommended recalibration interval?

testo recommends annual calibration against a certified reference standard; intervals may be adjusted based on risk assessment per ICH Q9 and internal SOPs.