Temperature under control
Pharmaceutical products demand precision. Our vehicles hold tight temperature windows reliably, with seamless documentation and audit-secure data capture.
Value proposition
What pharma logistics teams find at TBV
GDP-compliant from the factory
Bodies qualified to EU guideline 2013/C 343/01, with DQ/IQ/OQ/PQ documentation and mapping study for audit and authority acceptance.
Validated multi-zone
Independently controllable zones for 2 to 8 degrees, 15 to 25 degrees and below minus 20 degrees in one body, without compromise between the sections.
Seamless data chain
Calibrated sensors, ALCOA-plus compliant recording, real-time excursion alarms. Connectable to QM and ERP systems in pharmaceutical wholesale.
Concept
Pharma transport as its own discipline
Pharma transport is not refrigerated transport with higher requirements, it is its own regulatory system. We engineer bodies that are not made GDP-capable afterwards, but that emerge in the construction phase along the EU guideline 2013/C 343/01, AMWHV and PIC/S standards. Every wall thickness, every evaporator airflow and every sensor position is planned so that subsequent qualification delivers reproducible results. For pharmaceutical wholesalers and specialist couriers that means a vehicle that does not need to be explained in the GDP audit, but passed.
Qualification and configuration in detail
The EU GDP guideline requires that temperature conditions remain within defined limits throughout transport and that this is documented. In practice that means: the body itself must be qualified, not only the refrigeration unit. We work with the classic DQ/IQ/OQ/PQ scheme, starting with Design Qualification of insulation and airflow, followed by Installation and Operational Qualification of Thermo King or Carrier units, completed by a Performance Qualification under real loading and seasonal conditions. The mapping study identifies hot and cold spots and sets the final positions of the calibrated reference probes.
The second pillar is configuration: hygienic, low-joint GRP interior walls, contamination-free floor constructions without open profiles, redundant sensors with separate measurement and control loops. Multi-zone configurations with insulated bulkhead and a separate evaporator per section allow the parallel transport of 2 to 8 degree biologics and 15 to 25 degree CRT goods. Backup logic, door-opening logging and defined behaviour in case of unit failure are not additional options but audit criteria. All measurement components are delivered with DAkkS-traceable calibration certificates, typically recertified at twelve-month intervals.
Advantages
What counts in the pharma audit
Multi-zone bodies
Two to four independent temperature chambers, separate evaporator and control loop per zone. CRT goods and 2 to 8 degree biologics on one tour.
Contamination-free interior
GRP smooth walls, rounded interior corners, closed floor profiles, chemical-resistant coating. Cleaning validation possible, no dirt traps.
Audit-ready recording
Calibrated sensors, tamper-proof log data per ALCOA-plus, door status and vehicle position. Direct export for QM without media break.
Mapping and qualification
Complete DQ/IQ/OQ/PQ documentation, hot and cold spot mapping for summer and winter profile. Handover as audit-proof dossier.
Defined backup behaviour
Redundant power supply, standby cooling, unit failover, documented alarm path to dispatch and QA. Excursion events remain reliably verifiable.
Service and calibration intervals
Fixed twelve-month recertification of the sensors with DAkkS traceability, plannable maintenance and spare-parts stocking. Downtime is calculable.
Frequently asked questions about pharma
Yes, our pharma vehicles are designed for GDP-compliant transport. The integrated temperature monitoring logs seamlessly and delivers audit-secure reports.
From 2 to 8 degrees for chilled pharma products to controlled room temperatures (15 to 25 degrees). Deep-freeze ranges for special preparations are also configurable.
Our systems hold the temperature with a precision of 0.5 degrees. Multiple sensors in the cargo area ensure even distribution and early detection of deviations.
Yes, through integrated telematics you can track temperature in real time. In case of deviations you receive an immediate notification by SMS or email.
Temperature logs are stored digitally and can be exported at any time. Calibration records and maintenance logs complete the documentation for seamless audit trails.
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