Data Loggers for Pharmaceuticals

Yes, all TempTrail data loggers are FDA 21 CFR Part 11 compliant, providing secure, traceable, and tamper-evident digital records required for pharmaceutical and biologics regulatory documentation. Many models are also DO-160G certified for durability and CE, RoHS, and FCC certified for electromagnetic and safety compliance across regulated industries.

No. Each data logger automatically generates a PDF report and CSV file upon USB 2.0 connection, requiring no external software or drivers. You only need a Windows PC running Windows 7 or higher and Adobe Reader 9.0 or higher to view and print compliance reports.

Single-use models (e.g., TempTrail Classic, XL) are pre-configured, low-cost, and disposable after one shipment, ideal for one-way pharmaceutical logistics. Multi-use models allow user-configurable logging intervals, alarm thresholds, and battery replacement, making them more cost-effective for repeated warehouse monitoring or recurring cold chain shipments.

Storage capacity varies by model. Standard TempTrail loggers store up to 32,000 data points, while combined temperature and humidity models split this into 16,000 points per parameter. The entry-level TempTrail Classic stores up to 11,000 data points, sufficient for shipments lasting up to 75 days at standard logging intervals.

Most models feature an IP67 waterproof rating, protecting against dust and temporary water immersion during transit, while the TempTrail HiTemp autoclave logger is IP68 rated for full submersion in sterilization and wet processing environments. This ensures reliable data integrity even in harsh cold chain or cleaning conditions.

Yes, the TempTrail Humidity & Display model simultaneously tracks temperature (-30°C to +70°C) and relative humidity (0-100% RH) in a single compact device, available in both single-use and multi-use configurations, which is useful for humidity-sensitive pharmaceutical and biologic products.