Stabforum Stability Data Application Registration
 
Why does Baxter invest into stability data for its pump?

Over the last 30 years Baxter has generated stability data for more than 80 drugs used in its portable elastomeric devices.

  • Information available from a drug manufacturer (for example from the relevant SmPC) does not offer the required stability data for a specific container.¹
  • Published stability data may be of limited value because of inappropriate or inadequate analytical methodology, limited study duration or improper processing of analytical data.¹
  • The shelf life should be subject to on-going validation including robust control of any changes of materials or components.¹


For the safe and proper use of the devices mentioned herein, refer to the appropriate Instructions for Use.

¹A STANDARD PROTOCOL for DERIVING and ASSESSMENT, Part 1 - Aseptic Preparation (Small Molecules), 3rd Edition December 2015, NHS Pharmaceutical QA Committee.

 
Is Baxter's stability data unique to Baxter's Elastomeric device?
 
 
YES!
Stability studies are specific to the device tested and should not be extrapolated to other devices. When studying stability of a drug in a container, the drug behavior may be influenced by multiple elements, such as the contact material's absorption properties.
 
 
WATERLOSS AND THEREFORE CONCENTRATION INCREASES WILL DIFFER BASED ON THICKNESS OF MATERIAL AND THE CASING
Baxter's elastomeric material is made in our manufacturing plant using a unique proprietary formulation of polyisoprene rubber supplied by a trusted partner of more than 30 years.
 
 
STABILITY CAN BE AFFECTED BY ADDITIONAL FACTORS THAT COULD ALTER THE OUTCOME AND RELIABILITY OF THE DATA COLLECTED
For example, the sterilization method may differ (i.e. gamma vs. EtO vs. steam) or may be done at a different level. Baxter utilizes gamma irradiation to sterilize its elastomeric infusion devices.
 
 
 
 
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