Stabforum Stability Database

Why does Baxter invest into stability data for its elastomeric pump and IV solutions containers?

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

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

Is Baxter's stability data unique to Baxter's products?

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 the container closure system, as well as the thickness of material.

Baxter's elastomeric devices and solution containers are manufactured using unique proprietary formulations and processes that influence the stability and interaction with the drug formulation.

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. moist heat) or may be done at a different level.

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Baxter's elastomeric devices and solution containers are manufactured using unique proprietary formulations and processes that influence the stability and interaction with the drug formulation.

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

¹ A STANDARD PROTOCOL for DERIVING and ASSESSMENT, Part 1 - Aseptic Preparation (Small Molecules), 5th edition September 2019 , NHS Pharmaceutical QA Committee

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Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical, nutritional, renal, hospital and surgical care products and services. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen.

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