Compliance with RDC 430/2020, RDC 653/2022, and Route Mapping. Complete solutions to ensure cold chain integrity for pharmaceuticals.
Transporting temperature-sensitive pharmaceuticals faces critical challenges in Brazil.
Annual losses in Brazil due to cold chain breakdown in the pharmaceutical sector
Of Brazilian carriers are compliant with ANVISA requirements
Installation (IQ), Operational (OQ), and Performance (PQ) qualification per IN 35/2020. Complete thermal performance assessment of refrigerated vehicles.
Per RDC 653/2022, we perform mapping in summer and winter conditions, considering worst-case scenarios to ensure product integrity.
Thermal insulation testing, recovery capacity after door openings, and refrigeration system performance under real operating conditions.
RBC-calibrated data loggers with IoT for real-time temperature monitoring throughout the entire route, with alarms and automatic reports.
Complete guidance for BPADT implementation per RDC 430/2020, team training, and support in regulatory audits.
Establishes requirements for storage and transport of medicines, pharmaceutical inputs, and health products, including BPADT.
Provides requirements for medicine transport and establishes mandatory thermal route mapping under critical conditions.
Defines criteria for qualification of vehicles intended for transport of temperature-sensitive products.
Customized qualification plan defining measurement points, acceptance criteria, and procedures.
Strategic installation of RBC-calibrated sensors at critical vehicle points for accurate data collection.
Real operating condition runs including summer and winter scenarios as per regulatory requirements.
Statistical processing of collected data, identification of deviations and improvement points.
Conclusive technical report with charts, analyses, and qualification certificate.
Valid qualification certificate ready for audit presentation.
We are ready to help your company achieve the compliance and safety you need.
Our team is available Monday through Friday, 8am to 6pm.