OM-CP-AVS140-Series

Supported Applications

The OM-CP-AVS140 Series is a family of complete systems for autoclave validation, part of the NOMAD® Family. The systems enable compliance with FDA 21 CFR Part 11 and include NIST traceable calibration, making them suited to validating and mapping steam sterilization cycles in pharmaceutical, medical device, and laboratory settings.

Each system consists of data loggers together with the OM-CP-IFC400 USB docking station or OM-CP-IFC406 multiplexer interface and secure software with IQ/OQ/PQ validation protocols, so a validation engineer can deploy the loggers inside the chamber, dock them, and produce an auditable record of temperature (and, on the six-logger system, pressure) throughout the cycle.

Operating Conditions & Performance

The temperature data logger uses a 100Ω Platinum RTD and measures -40 to 140°C (-40 to 284°F) at the body and -200 to 260°C (-328 to 500°F) at the probe, with a resolution of 0.01°C (0.02°F) and a calibrated accuracy of ±0.1°C (±0.18°F) [20 to 140°C (68 to 284°F)].

The pressure data logger uses a semiconductor strain gauge over a range of 0 to 5 bar (0 to 72.5 psia):

• Pressure resolution: 0.1 mBar (0.0015 psia).
• Pressure calibrated accuracy: ±0.03 Bar (±0.435 psi) (20 to 140°C/68 to 284°F).
• Pressure response time: 0.1 ms (10 to 90% FSR).
• Repeatability: ±0.5% FSR; ±0.2% typical.

Common to both loggers, memory holds 32,700 readings with software configurable memory wrap, the reading rate spans one second up to once every 24 hours, and power comes from a 3.6V high-temperature lithium battery (included). The computer interface runs at 125,000 baud through the OM-CP-IFC400 or OM-CP-IFC406. Operating environment is 0 to 100% RH. Systems carry CE, NIST Traceable Calibration, and FDA 21 CFR Part 11 compliance.

Configuration Options

The two systems differ in the parameters they validate and the number of loggers supplied:

OM-CP-AVS140-1 — Temperature

A temperature-only autoclave validation system. It includes one OM-CP-HITEMP140-1 temperature data logger with a NIST calibration certificate, an OM-CP-IFC400 USB docking station, and the FDA 21 CFR Part 11 secure software. The temperature logger offers a battery life of 1 year typical.

OM-CP-AVS140-6 — Temperature and Pressure

A temperature and pressure autoclave validation system. It expands the deployment to five OM-CP-HITEMP140-1 temperature data loggers with NIST calibration certificates plus one OM-CP-PR140 pressure data logger, adding the semiconductor strain-gauge pressure channel described above. The pressure logger offers a battery life of 2 years typical.

Key Product Differences

The model lineup consists of two complete systems:

• OM-CP-AVS140-1 — autoclave temperature validation system: one OM-CP-HITEMP140-1 temperature data logger with NIST calibration certificate, OM-CP-IFC400 USB docking station, and FDA 21 CFR Part 11 secure software.
• OM-CP-AVS140-6 — autoclave temperature and pressure validation system: five OM-CP-HITEMP140-1 temperature data loggers with NIST calibration certificates and one OM-CP-PR140 pressure data logger.