Rapid Freeze-Thaw Performance of Single-Use PFA Bottles

Can Single-Use Containers Survive Dramatic Temperature Changes?

The most demanding processes that utilize single-use containers – like bulk drug substance (BDS) storage – often involve rapid and vary large shifts in temperature.

So called “flash freezing” is commonly used for vaccines and blood products due to concerns over protein stability. But what’s not so common? A single-use container system that can survive this process.

In fact, withstanding extreme temperature changes, for example, from 40^OC down to -85 ^OC, or even 196^OC, is one of the biggest technical hurdles for single-use products.

Single-use bags and bottles are normally made from materials such as PE (Polyethylene), PP (Polypropylene), PC (polycarbonate) and PETG (Polyethylene terephthalate glycol). These are all polymers designed for stable processes with little variability.

But when you challenge those materials with rapid temperature changes, strong chemicals – or both – they change structurally. This can lead to catastrophic failure – and loss of contents.

Single-use containers made from fluoropolymers, on the other hand, have been shown to work well when challenged with extreme temperatures and other rapidly changing physical and chemical environments.

Putting Fluoropolymers to the Test

Savillex performed a series of freeze-thaw experiments to show how well its ready-to-use Purillex^® PFA (perfluoroalkoxy) bottles could withstand rapid temperature changes while maintaining structural and seal integrity.

Bottles were first frozen at -85° C for 24 hours and then placed directly into a 37° C water bath until completely thawed.

This short video shows the PFA bottles being removed from a freezer and placed into a water bath.

The freeze-thaw procedure was repeated 20 times for each bottle. Following that, hydrostatic leak tests at two psi and 15 psi were conducted to check the seal integrity of the bottles.

No damage or seal failure was found in any of the Purillex^® bottles following 20 rapid freeze-thaw cycles. These test results clearly show that Purillex^® PFA bottles from Savillex are a very reliable choice for storing BDS at -85 ^OC

Want to know even more about the complete lineup of Purillex^® single-use bottles? Get full technical details and more.