Extended Stability of Intravenous 0.9% Sodium Chloride Solution After Prolonged Heating or Cooling

Posted by Katja Wolff on

The Extended Stability Study

A 2014 study published in Hospital Pharmacy looked at the extended stability of 0.9% sodium chloride solution for intravenous therapy under prolonged heating and cooling. Study author Enrique Puertos, PharmD sought to evaluate the stability of the solution when cooled or heated for an extended time. The goal was to look for ways to push past the 28-day shelf life recommended by IV fluid manufacturers.

Puertos’ wanted to determine if it was possible to reduce the amount of wasted 2 L sodium chloride bags at his hospital. The facility provides six ambulance services with two refrigerated and two heated bags a month. After 28 days, the bags become waste — totally up to 40 bags a month of lost expenditure and inventory.

The Study Parameters

For this study, Puertos used 15 sterile, analytical grade 1L bags of 0.9% sodium chloride solution that were selected randomly. He:

  • Refrigerated five of them at 5.2 degrees Celsius in a Gem refrigerator
  • Heated five in a warmer at 39.2 degrees Celsius
  • Left five out in room temperature of 21.8 degrees Celsius to be controls

Puertos measured the sodium concentration with the Synchron LX system chemistry analyzer using indirect potentiometry. All samples were proven sterile prior to use, and the 15 bags each had their overwrap intact. Each sample group existed under the same light protected setting. Puertos ran the study for 199 days, after which he analyzed the solution for microbial growth.

Study Results

All three samples maintained a similar sodium concentration:

  • The refrigerated sample was 150 mmol/L.
  • The heated sample was 155 mmol/L.
  • The control sample was 151 mmol/L.

Clinically, these values are equal. There was a statistical difference between the heated sample and the control group attributed to water loss from extended heating. Still, it had no bearing on the use of the solution. With that in mind, the difference is not clinically significant. The heated and refrigerated group each had a relative error of less than 10 percent compared to the control group.

Study Conclusion

The study author was able to establish that the sterile intravenous solution could remain stable and free of microbial or fungal growth for at least 199 days, the length of the study. That extends the shelf life of each bag by more than seven months, saving a total of 280 units regularly discarded when they go past the recommended expiration date.

Puertos found the bags remained both sterile and stable, whether heated, refrigerated or stored at room temperature. This study has the potential to save hospitals and emergency facilities considerable cost and time by extending the expiration date assigned to IV fluid bags.

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