Fluke Thermal Validation System Complies with Regulations:

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

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

◆ Meets European standards for sterilization, disinfection, and sanitization (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 thermal process validation through Temperature Uniformity Survey (TUS) and System Accuracy Test (SAT) procedures as required by AMS 2750.

Features:

Flexible Configuration — Suitable for both field and laboratory use

Easy Wiring — Dedicated wiring method, quick connect and disconnect

Simple Operation — Free switching between Chinese and English, color screen, user-friendly button design

Automatic Calibration — Controls heat source and fully automates temperature sensor calibration

Simultaneous Validation — Supports validation of multiple devices at the same time, such as QC high-temperature chambers and incubators

Safety Rating — Complies with CAT II safety rating

Product Applications

Steam sterilizers, tunnel ovens, dry heat ovens, ETO sterilization equipment, freeze dryers, constant temperature and humidity chambers, warehouses, etc.