Packaging Assembly Preventing Premature Drug Activation
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Solution Overview
Problem
The reconstitution process of lyophilized drugs for injection is challenging due to the need for sequential manipulation of drug and diluent containers, which requires aseptic practices to prevent contamination and premature activation during shipment and handling, increasing the risk of accidental puncture and sterility loss.
Innovation Solution
A packaged assembly with a housing that cradles the reconstitution assembly, featuring radially spaced apertures and windows, and a transfer set assembly with spikes that communicate fluidly, while protrusions and recesses in the package prevent axial translation and rotation of containers, minimizing the risk of premature puncture and maintaining sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If the reconstitution assembly components are mounted within the same housing at time of shipping, then the device integrates multiple functions in a compact form, but the risk of accidental premature puncture or activation of stoppers increases during shipment and handling
Solution Approach 1:
The package is divided into separate compartments: a first compartment for the drug container and a second compartment for the diluent container. This segmentation physically separates the components that could accidentally interact, preventing premature activation while maintaining integrated packaging.
Solution Approach 2:
A barrier element is introduced as an intermediary between the drug container stopper and the diluent container stopper. This barrier prevents direct contact and accidental puncture between the two containers during shipping, allowing the assemblies to be mounted together in the same housing.
2Ease of operation
If the transfer syringes are positioned to communicate fluidly with the containers, then the reconstitution process is enabled, but the risk of contamination and accidental puncture increases during shipment
Solution Approach 1:
The barrier element acts as an intermediary that allows the transfer syringe to access the drug container stopper while preventing the diluent container stopper from accidentally puncturing the drug container. This maintains the intended fluid communication path while blocking harmful accidental interactions.
Solution Approach 2:
The barrier element provides localized protection at the interface between the two containers. It allows fluid communication where needed (for the drug container) while blocking accidental puncture paths (protecting the diluent container stopper), creating different functional qualities in different locations.
3Productivity
If the containers are positioned close to the spikes for efficient reconstitution, then the activation process is simplified, but the likelihood of accidental puncture during handling increases
Solution Approach 1:
The barrier element is positioned between the containers and the spikes, allowing the spikes to remain in place for efficient activation while preventing accidental contact. The barrier can be selectively removed or breached during intended activation but blocks unintended contact during handling.
Solution Approach 2:
The barrier element provides preliminary protection against accidental puncture before the reconstitution process begins. It counteracts the potential harmful effect of the spikes being positioned close to the containers during shipping and handling.
Data Source
AI summary
A package assembly for a drug reconstitution assembly includes a body, a drug reconstitution assembly and a removable lid. The body includes a plurality of protrusions configured to mate with a plurality of corresponding features of the drug reconstitution assembly to inhibit axial and rotational translation of the drug reconstitution assembly and its constituent parts during shipping and handling. By preventing axial and rotational shifting during shipment, premature and accidental puncture or contamination of the medication or the spikes within the drug reconstitution assembly is minimized.