Pharmaceutical Dispensing Vessel with Agitation and Sterile Barrier
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Solution Overview
Problem
Current methods for formulating and dispensing pharmaceutical suspensions lack control and automation, leading to potential contamination and variability in final formulations when manually transferred into aliquots.
Innovation Solution
A system and method involving a container with agitation and temperature control, connected to portals for aseptic transfer and dilution, which calculates and adds dilution solutions to achieve target concentrations, ensuring homogeneity and sterility during the formulation and dispensing process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If manual dispensing into aliquots is used, then device complexity is reduced, but manufacturing precision and reliability deteriorate due to contamination and variability
Solution Approach 1:
A sterile barrier film is introduced as an intermediary between the non-sterile external environment and the sterile pharmaceutical suspension. The film allows controlled interaction (dispensing) while maintaining sterile isolation, enabling automated precision dispensing without compromising formulation homogeneity or introducing contamination
Solution Approach 2:
The system performs self-service through automated agitation and temperature control mechanisms that maintain suspension homogeneity and homeostatic conditions independently. The automated dispensing mechanism operates without manual intervention, consistently delivering precise aliquots while maintaining formulation integrity
2Device complexity
If manual transfer into aliquots is used, then device complexity is reduced, but reliability deteriorates due to contamination risks
Solution Approach 1:
The sterile barrier film serves as a mediator that separates sterile and non-sterile environments. It enables the system to maintain reliable sterility without requiring complex sterile housing or environmental controls, as the film itself provides the sterile boundary during dispensing operations
Solution Approach 2:
The system creates a protected environment by sealing the pharmaceutical suspension in a container with a sterile barrier, effectively creating a controlled atmosphere that prevents contamination. This approach maintains reliability by eliminating exposure to external contaminants while allowing controlled dispensing
3Manufacturing precision
If automated agitation and temperature control are added, then manufacturing precision improves, but device complexity increases
Solution Approach 1:
Multiple functions (agitation, temperature control, dispensing, and sterile barrier) are merged into a single integrated container system. This consolidation achieves high manufacturing precision for suspension homogeneity while minimizing overall device complexity by eliminating the need for separate external systems for each function
4Manufacturing precision
If dilution solution addition is automated, then manufacturing precision improves, but ease of operation deteriorates
Solution Approach 1:
The system performs self-service by automatically calculating and adding the precise amount of dilution solution needed to achieve target concentrations. The automated mechanism eliminates manual measurement and addition steps, ensuring concentration accuracy while the system manages its own formulation process independently
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach maintains homeostatic conditions and homogeneity of pharmaceutical suspensions, enabling precise and sterile dispensing into aliquots without the need for a sterile environment, reducing contamination risks and variability.
Implementation Method 1
agitating the initial liquid formulation
Implementation Method 2
a means for controlling temperature inside the container
Data Source
AI summary
The present disclosure relates to use of specialized vessels for formulating and dispensing pharmaceutical formulations. The vessels are optionally able to maintain homeostatic conditions and a homogeneous constitution of pharmaceutical suspensions, while simultaneously dispensing them into single-use containers.