Holder and sublimation rate monitoring device for freeze-drying with dual chamber syringes

Holder system and sublimation rate monitoring device for freeze drying with dual chamber syringesThis technology overcomes the traditional challenges of determining freeze-drying protocols that are often challenging, inefficient, and time consumingThe …
  • Holder system and sublimation rate monitoring device for freeze drying with dual chamber syringes
  • This technology overcomes the traditional challenges of determining freeze-drying protocols that are often challenging, inefficient, and time consuming
  • The 3-piece holder system and sublimination rate monitoring device supports and optimizes the development of new and tailored freeze-drying protocols

Background and Unmet Need

Developing predictive models for freeze-drying requires experimental data. Some of this data is provided by pressure and temperature measurement tools, but acquiring information about one of the key parameters, namely sublimation rate, faces challenges. The two common techniques that are used for this purpose are the conventional gravimetric method and TDLAS, which both exhibit technical limitations. Thus, the determination of freeze-drying protocols can be challenging and require time-consuming experimental work, as several trial and error experiments must be conducted for each product and freeze dryer in order to determine acceptable run conditions. Such an approach is not only time-consuming and labor intensive but can also result in sub-optimal protocols being used. This situation is particularly challenging when the container geometry is modified, such as is the case with dual-chamber syringes (DSC). In these cases, accurate models of freeze-drying phenomena do not exist or are inaccurate.

Technology

UConn researchers have developed a three-piece holder system that enables seamless and uniform heat transfer from the shelf to the chamber containing the frozen solution. In addition, they have developed a sublimation rate monitoring apparatus. The apparatus design enables the weight of individual containers to be continuously monitored in situ. The proposed solution has been developed around DCS containers that lend themselves well to being hung from a measurement device while preserving their heat transfer interaction with the holder. The proposed monitoring apparatus can be attached to or detached from the rest of the holder (depending on whether it is needed or not) for a specific run without influencing the performance of the freeze-drying run. The user can monitor the weight while the freeze-drying run is taking place via wireless communication.

Advantages:

Supports the development of new and tailored freeze-drying protocols without burdensome experimental work
Enables continuous monitoring of the sublimation rate of individual containers inside the freeze dryer
Potential to determine ideal drying times to ensure product quality and maximize throughput
Holder design produces optimized (controlled and predictable) heat transfer
Apparatus can be implemented as an add-on to commercially available freeze dryers with no design modifications needed to provide real-time monitoring capabilities
Supports freeze-drying in DCS
Fewer preparation and injection steps are required for DCS when compared to traditional vial/syringe combinations (no need for multiple needles or transfer devices)
The all-in-one design of DCS allows for precise dosing and helps to minimize reconstitution errors

Website

https://uconn.flintbox.com/technologies/3E210FB3EFC5408696EF20FAAAC8CDB5

Potential Applications:

Market Application:

  • Freeze drying of cartridges/vials and dual-chamber syringes

Contact Information:

  • Name: Neeraj Visen
  • Title :
  • Department :
  • Email : nv@uconn.edu
  • Phone : 860-486-8330
  • Address :