Real-time Wireless Temperature Data Logger for Autoclave Sterilization Validation Japan Laser Corporation

Quality assurance and validation engineers in pharmaceutical, biotech, and medical device manufacturing plants; engineers responsible for autoclave temperature mapping and Performance Qualification (PQ); manufacturing line managers seeking to streamline GMP-compliant sterilization process management and record-keeping; quality control departments considering FDA 21 CFR Part 11-compliant electronic records and e-signatures

Temperature mapping and uniformity evaluation inside autoclave chambers (dramatically reducing time for sensor placement and retrieval vs. wired systems); real-time temperature monitoring of steam sterilization cycles with automated F-value calculation for sterility assurance; documentation for IQ/OQ/PQ validation studies with electronic signatures and audit trails; accumulation and management of repeatability and accuracy data for periodic performance qualification tests

① Loggers placed directly inside the autoclave with real-time wireless data transfer: No cabling required, unlike thermocouple-based wired systems—dramatically reducing time for sensor setup and retrieval.
② True real-time monitoring (unlike typical wireless loggers): Live data displayed on PC software during sterilization, enabling immediate anomaly detection without waiting for post-cycle data retrieval.
③ Industry-leading accuracy: 4-wire PT-100, ±0.1°C guaranteed for 1 year: Full-range accuracy of ±0.1°C across -90 to +140°C guaranteed for 1 year after manufacturer calibration by Lives International.
④ FDA 21 CFR Part 11-compliant dedicated software: Standard features include trend graphs, F-value calculation, electronic signatures, audit trails, and automatic pass/fail judgment—covering GMP compliance in a single solution.
⑤ 3 models to suit different applications: Temperature-only (GMPF_RF_30H), 5-sensor model (GMPF_RF_5F), and combined temperature + pressure model (GMPF_RF_TP_F). Custom configurations also available.