Supply chain management of temperature-sensitive products places especially high demands on process design and control.

Legal regulations such as 21 CRF and SUP [1079] in the United States, the EU Directive 2001/83/EC or the EU Guideline 94/C63/03 for Good Distribution Practice require that thermolabile products always be stored and transported in a way that does not compromise their integrity.

Quality advantage through expertise

arvato services healthcare has established itself as a leading provider of high-quality and reliable logistics systems for temperature-sensitive products.
This applies to all standard temperature ranges: -70°C, - 20°C, +2°C to +8°C and +15°C to +25°C.
Non-standard requirements are accommodated through individual solutions developed jointly with the customer.

Seamless temperature tracking

arvato services healthcare guarantees consistent, end-to-end maintenance of defined temperature ranges and seamless temperature tracking from when the goods are first picked up from the producer until their final delivery to the recipient. In particular, this includes systematically integrating distribution center activities into the process and information chains. A uniform IT system that combines the internal processes of the service provider with those of our system partners in real time enables a unique base of data that creates transparency, and with it, security.

Aligning these highly complex logistical processes with the quality requirements while maintaining an attractive price-performance ratio is especially crucial in the “micro-distribution” of orders from hospitals, laboratories, pharmacies and pharma wholesalers, which have to be processed and shipped with very quick turnaround times.

Best practices: cold chain management

To meet heightened cold chain management requirements, a new cold storage warehouse was recently commissioned in Germany as part of a larger customer project, expanding the cold storage capacity at this site to some 1200 pallet spaces.

Special attention was given to state-of-the-art planning and qualification:

• The design qualification (DQ) ensured that the materials and equipment met the required specifications.
• The installation qualification (IQ) documented the technically correct installation of the design established in the DQ according to the legal safety standards and customer safety specifications.
• The operation qualification (OQ) documented how compliance with the planned specifications will be ensured during operations. Temperature thresholds and alert values under defined conditions were established, for example, and extreme conditions and emergency scenarios were tested and documented.
• The performance qualification (PQ) made sure that the equipment would deliver the required performance in the physical environment and at different load levels.

The basis for this last optimization is an extensive temperature mapping with over 50 mobile data loggers. The coldest and warmest points in the refrigerated storage unit were ascertained for installation of the alarm sensors. The system controls are set according to the load level and keep the temperature between 2°C and 8°C. An emergency power generator switches on automatically during power failures to ensure uninterrupted cooling. Controlled temperatures in different areas of the storage facility include “ambient” (+15°C/+25°C), “cooled” (+2°C/+8°C) and subzero ranges from -20°C to -70°C.