PRODUCT SPOTLIGHT TrackSense® LyoPro Wireless Data Loggers In this Product Spotlight we will present you with some of the many advantages of using our new LyoPro Data Logger. LyoPro is designed specifically for validation and batch control of freeze drying units that use automatic vial loading and unloading systems in the pharmaceutical industry. Background During lyophilization in the pharmaceutical industry, it is very Achieve Minimum important to measure the critical ice temperature of the product inside of vials. These measurements are crucial to avoid the loss of batch, as well as to determine the end of primary drying and the start of secondary drying – allowing you to save precious time. To address the challenges of freeze drying, Ellab developed the LyoPro data logger with various fittings and fixtures to reliably measure the product temperature. The StopperClip is specifically designed for keeping the data logger and vial together when operating automatic loading and unloading systems. While also simulating the actual sublimation taking place within the sample vial. Throughout the entire process, the StopperClip firmly holds the thin LyoPro thermocouple sensor in place – ensuring an accurate and repeatable result. Which in turn, also allows the data logger and sensor to safely pass through the process without being damaged. All LyoPro systems include a wireless LyoPro data logger, 10-slot reader station and an Access Point for LIVE data The StopperClip is equipped with a PEEK tube that allows you to mount the sensor at the exact spot for critical ice temperature (hot spot) inside the vial. The data logger is equipped with an extremely thin thermocouple sensor (0.55 x 0.95 mm) that fits perfectly in The extremely thin profile of the replaceable thermocouple the special StopperClips designed for pin-point and sensor ensures minimal displacement of the product volume repeatable placement within various vial sizes. Ultimately, - thereby resulting in little to no impact on the measuring the critical ice sample temperature for controlled validation and batch control.

PRODUCT SPOTLIGHT LyoPro Wireless Data Loggers Long Process Duration and Stored Data The LyoPro data logger not only transmits LIVE data, but simultaneously stores measurements in the data logger memory to avoid data gaps. It does so by incorporating a high-capacity battery designed to function at extremely low temperatures. This battery can easily be replaced by an operator without the use of tools. Each LyoPro data logger has a non-volatile memory capacity of 100,000 samples, which equals a sampling time of: • 27 hours with a 1 sec. sampling rate 135 hours (6 days) with a 5 sec. sampling rate...

PRODUCT SPOTLIGHT LyoPro Wireless Data Loggers Working with autoloading systems that provide limited Data Analysis, Data Integrity and FDA Compliance all in one manual access to the vials poses many challenges, but these can be overcome through the following 3-step procedure: 1. The LyoPro data logger is configured with a thermocouple sensor and StopperClip, and then sterilized together at 121 °C for a maximum of 30 minutes before being introduced into the isolator area Tying it all together is the FDA 21 CFR Part 11 compliant 2. Within the isolator, the LyoPro data logger is placed onto the...