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For Critical Thermal & Cold Chain Validation
Each ValProbe Standard logger is equipped with high-precision sensors and non-volatile memory to securely store millions of data points, ensuring that comprehensive thermal history is captured without compromise. This technical specification is paramount for long-duration studies, such as stability chamber mapping or extended cold chain monitoring, where uninterrupted data capture is a fundamental compliance mandate. The loggers' stainless steel construction and specialized designs (e.g., Cryo and Freeze Dryer loggers) mean they can withstand extreme temperatures, pressures, and harsh chemical environments, maintaining measurement integrity where other devices would fail.
The system utilizes specialized ValProbe Reader/Interface units for efficient logger programming and rapid data downloading after the study is complete. This sequential methodology minimizes the time personnel must spend inside a controlled environment, which is highly beneficial in cleanroom or sterile settings where traffic must be restricted. The associated software then automatically organizes and processes the collected data, generating GxP-compliant reports, F0 calculations, and uniformity analysis, moving the user quickly from raw data collection to final, audit-ready documentation.
The ValProbe loggers feature certified, high-stability internal Reference RTDs (Resistance Temperature Detectors) to ensure long-term thermal drift is minimized, a critical factor for multi-month stability mapping studies. This design ensures the accuracy of the logged data remains consistent over extended periods, directly addressing the difficulty of maintaining Measurement Accuracy when validation campaigns last for weeks or months without intermediate calibration.
The loggers incorporate robust, hermetically sealed stainless steel casings, making them inherently Contamination-Resistant and suitable for direct placement within critical process environments like high-pressure steam sterilizers or hazardous atmospheres. This eliminates the need for complex protective measures and ensures the integrity of the surrounding controlled environment is not compromised by non-sterile monitoring equipment.
Each logger contains sufficient non-volatile Memory Capacity to store comprehensive data for multiple long validation runs before requiring download. This massive storage capability eliminates the operational worry of running out of space mid-study, a major frustration when validating extremely long cycles such as prolonged stability storage or extended cold chain transportation routes.
The loggers' design facilitates a very rapid, electronic Initialization process via the ValProbe Reader unit, minimizing the manual steps required to prepare the devices for deployment. This simplicity significantly speeds up the pre-study setup phase, ensuring that validation personnel can deploy numerous loggers efficiently and accurately without the lengthy configuration steps typical of older, wired systems.
Specialized logger variants, such as the Cryo logger, are engineered to function reliably and precisely at extreme sub-zero Temperature Extremes, including those found in liquid nitrogen freezers. This technical specialization provides a highly accurate and dependable solution for validating processes that are often difficult to monitor, guaranteeing data capture in environments down to -196°C.
Data retrieved from the loggers is automatically processed by the software to perform statistical analysis and calculate critical Lethality Values (F0, A0), essential for regulatory documentation of sterilization processes. This automated calculation removes the reliance on manual data entry and external spreadsheets, improving the speed and accuracy of compliance reporting.
The ValProbe system utilizes a unique, electronic key-based Data Security protocol during logger programming and download, ensuring that only authorized and validated software can access or modify the study data. This technical security layer is crucial for meeting the stringent requirements for protecting electronic records and preventing unauthorized data manipulation.
The physical dimensions and completely cable-free operation of the loggers ensure unparalleled Environmental Versatility, allowing them to be placed directly into product containers or difficult-to-reach locations inside small equipment. This ability ensures true product temperature monitoring, which is a necessary technical requirement to prove thermal penetration and product protection during validation studies.
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