GxP Services for logistics & shipping
The protection of product quality during transport and storage of, for example, medicines is an important and essential component of the GxP directive. The basis for observance of legal regulations is GxP-compliant qualification of the transport equipment or storage facility. The ROTRONIC After Sales Service has specialized in these services and offers you an efficient solution tailored exactly to your requirements. Temperature mapping service available (warehouses, production rooms, climate cabinets, climate chambers, trucks, etc.).
Typical mapping applications: production & storage in the pharmaceutical industry, food industry and wherever temperature sensitive products are stored.
ROTRONIC will discuss the modules needed for qualification with you and propose the best possible time schedule for the qualification procedure. Thanks to the modular structure of this service, you only pay for the qualification steps you need; this approach has proven itself in many reference projects and has also found favor with our customers worldwide. A ROTRONIC qualification engineer will explain and substantiate the GxP-compliant data directly on customer request in the case of an possible audit.
- Warehouse qualification & validation (climate mapping)
- Transport qualification
- Climate chamber mapping
- Maintenance & installation of the measuring systems
- On-site calibrations
- Exact data on the climate in the room
- Mapping conforming to FDA & GxP
- Knowledge of possible danger zones in the controlled climate
MICHELL Optidew Chilled Mirror Hygrometer
The Optidew is a fast-responding chilled mirror hygrometer, equally at home in both industrial humidity control and precision laboratory applications.Learn More
RMS-LOG-L-D – Data logger with displayThe RMS-LOG-L-D stores up to 44,000 pairs of measured values from the interchangeable CO2, differential pressure, humidity, temperature or low dew point probe, and transmits them to the RMS database via LAN link. Learn More
HygroLog HL-1D - INEXPENSIVE DATA LOGGERHumidity and temperature data logger. Compact, dependable and inexpensive. HL-1D Data Logger fulfills the guidelines in accordance with EN 12830. Learn More
HygroLog TL-1D - Data Logger for TemperatureTemperature data logger. Compact, dependable and inexpensive. HygroLog TL-1D fulfills the guidelines in accordance with EN 12830. Learn More