Fluke Thermal Validation System Complies with Regulations:

◆ Adheres to the U.S. Food and Drug Administration (FDA) 21 CFR Part 11 regulations on electronic records and signatures for validation applications in incubation, sterilization, freezing, drying, and temperature testing within the pharmaceutical and biomedical industries.

◆ Developed in accordance with the International Society for Pharmaceutical Engineering (ISPE)'s Good Automated Manufacturing Practice (GAMP).

◆ Complies with European sterilization, decontamination, and disinfection standards (EN554, EN285, EN15883, HTM2010, HTM2030), ISO 15833 requirements for washer-disinfectors, and ISO 17025 competency requirements for testing and calibration laboratories.

◆ Has been audited by major pharmaceutical companies, and its quality documentation has passed FDA review.

◆ Supports heat treatment process validation through Temperature Uniformity Survey (TUS) and System Accuracy Test (SAT) procedures as required by AMS 2750.

Fluke Data Acquisition System Functional Parameters:

◆ Basic DC voltage measurement accuracy 0.0024%    ◆ PRTD accuracy ±0.02℃   ◆ Thermocouple measurement accuracy 0.5℃

◆ Standalone multi-channel differential isolated input with up to 66 channels      ◆ Color trend graphics and analysis   ◆ User-friendly menu system

◆ Multiple input types: AC/DC voltage, AC/DC current, thermocouples, platinum resistance (2/3/4 wire), thermistor resistance (2/4 wire), frequency                        

◆ Multi-channel real-time data display                  ◆ 6.5-digit digital multimeter functionality

◆ Real-time observation and plotting of scan data

◆ Configurable 20 math calculation channels? One-key screenshot function  ◆ Scan rate: 43 channels/second  ◆ Front panel USB interface

◆ Internal memory can store 75,000 scan data points/1,000 setup files     ◆ Data security protection function

◆ CAT II 300V input safety rating             ◆ Supports standalone operation for data acquisition