Distribution of dialysis fluids - Is transport and storage optimised from a temperature point of view?

Abstract: The background to this thesis is the fact that high temperature during transport and storage, degrade the glucose of peritoneal dialysis fluid (PD-fluid), into a toxic substance. Research at Gambro has shown that exposure to high temperatures can destroy the PD-fluid in just a few hours, requiring months to repair. With this knowledge it became important to monitor the temperature, and evaluate which temperatures the product is exposed to in the distribution chain. This to conclude if the product will reach the patient with high quality, guaranteeing well-being. The focus of the research has been to clarify which temperatures the PD-fluid is exposed to during distribution from production to the patients. The centre of attention has been the distribution between Italy and Sweden, where the three-compartment bag (trio) has majority of market shares. It is the conventional PD-fluid, not the trio that is harmed due to high temperatures. All the same, the study of this thesis should be seen as a pilot case and the experience gathered can be applied to any distribution chain, supplying conventional fluid or not. To analyse if the distribution chain is optimised from a temperature point of view, an in-depth mapping was made. Monitoring the temperature and taking part of previous temperature studies identified critical points in the distribution chain. Interviews, observations and document reviews were moreover an important part of the research strategy. Throughout the research, the authors evaluated existing temperature awareness among the stakeholders. By monitoring the temperature and taking part of previous temperature studies, it was concluded that critical temperatures exist, mainly due to transport. The PD-fluid was exposed to temperatures below the restricted 4°C a couple of times. In one case the fluid was exposed for a temperature below zero. To avoid this, tempered trucks are recommended. From evidence in previous studies by Gambro, it was obvious that temperatures above the restricted 30°C occur. This happens in the worldwide container transports. Gambro has to consider reefer containers in those cases were there is a risk for the conventional PD-fluid or any temperature sensitive goods might be subjected to temperatures exceeding 30°C. The warehouses in Italy and Sweden have a good control of their warehouse temperatures, which are regularly monitored. There is a huge lack of temperature awareness among the Gambro stakeholders, and this is according to the authors, the explanation why the temperature control is lost during transport. On the whole the warehouse temperature is controlled, but as soon as the product is in the hands of an external actor, the control is lost. With an increased awareness about why the conventional PD-fluid is temperature sensitive, most critical handling in the distribution chain could be avoided, and thereby decrease the need for temperature-controlled transports. As a second part of the thesis a temperature monitoring system, developed by Bioett AB, was evaluated to conclude if it indirectly could indicate the quality of the conventional PD-fluid. The Bioett system could to some degree monitor the temperature, and reflect the total amount of glucose degraded, but for which purpose? To be successful for Gambro, the monitor system has to indicate if it affects the quality or not, which the system does not. The biological activity of the glucose in the PD-fluid, which is time- and temperature dependent, is more complex than the Bioett system and it can therefore not indicate the quality of the PD-fluid. It is the authors? believe that with an improved awareness, transport and storage will be optimised, since the control throughout the distribution chain will be improved. Involved parts will have a better understanding and guidance and thereby take on correct actions if anything out of the ordinary would take place.