Multi-Vial Adapter Fluid Paths for Aseptic Drug Reconstitution
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Solution Overview
Problem
The process of reconstituting and diluting lyophilized or concentrated drug products is complex, time-consuming, and prone to contamination, especially when multiple vials are involved, hindering self-medication and increasing the risk of dosing errors and waste.
Innovation Solution
A multi-vial adapter with a primary interface for a diluent source and secondary interfaces for drug product vials, featuring fluid paths and securing mechanisms, allows simultaneous reconstitution or dilution of multiple vials, ensuring sterility and accurate dosage preparation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple vials are reconstituted or diluted in a serial manner using conventional methods, then each vial can be prepared individually with controlled sterility, but the preparation time increases significantly and the process becomes complex and tedious
Solution Approach 1:
The patent combines multiple vial reconstitution operations into a single parallel process using one adapter device. The adapter simultaneously connects to multiple vials and a diluent source, enabling concurrent reconstitution of all vials rather than sequential processing. This merging of operations maintains sterility through sealed connections while dramatically reducing preparation time.
Solution Approach 2:
The adapter serves multiple functions: it acts as a connection hub for multiple vials, a diluent delivery system, a sterility barrier, and a flow distribution network. This multi-functional design eliminates the need for multiple separate devices or manual operations for each vial, streamlining the overall process while maintaining controlled conditions.
2Productivity
If multiple vials are reconstituted or diluted simultaneously using a multi-vial adapter, then preparation time is reduced and the process is simplified, but the device complexity increases
Solution Approach 1:
The adapter is designed with segmented functional zones: a body portion for structural support, a diluent source connection interface, multiple vial connection interfaces, and internal fluid pathways. This segmentation allows each component to perform its specific function while keeping the overall design modular and manageable, reducing the perceived complexity despite the multi-functional capability.
Solution Approach 2:
The adapter acts as an intermediary device that mediates between the diluent source and multiple vials. Rather than requiring direct manual manipulation of each vial, the adapter serves as an intermediate platform that automates and coordinates the dilution process, simplifying user interaction while managing the inherent device complexity through standardized interfaces.
3Ease of manufacture
If conventional serial reconstitution methods are used, then equipment requirements are minimal, but the risk of contamination and dosing errors increases
Solution Approach 1:
The adapter is designed as a disposable single-use device, eliminating the need for complex sterilization and validation procedures required for reusable equipment. This disposable approach maintains high reliability by ensuring each adapter is sterile upon use and is discarded after a single application, preventing cross-contamination while keeping the device structure relatively simple and cost-effective.
Solution Approach 2:
The adapter creates a closed, sterile environment for the reconstitution process, isolating the drug products and diluent from external contamination sources. This controlled inert environment maintains reliability by preventing microbial contamination and particulate contamination throughout the preparation process, while the adapter's simple sealed design achieves this without requiring complex active sterilization systems.
4Quantity of substance
If dozens of vials are diluted and reconstituted, then the required dosage can be achieved, but drug waste due to dead volume increases significantly
Solution Approach 1:
The adapter utilizes fluid dynamics and pressure differentials to efficiently transfer diluent from the source through multiple pathways into each vial. This hydraulic approach ensures complete and uniform distribution of diluent, maximizing drug reconstitution efficiency and minimizing residual drug left in vials or dead volumes, thereby reducing waste while achieving the required total dosage.
Data Source
AI summary
The present disclosure is directed to adapters for mixing vials of drug products, and more specifically to multi-vial adapters for reconstituting lyophilized drug products and/or diluting concentrated drug products. It is an object to address one or more of drawbacks in connection with the drug preparation process, for example, by simplifying the procedure where multiple vials are required to be diluted or reconstituted in a serial manner. As such, the multi-vial adapters described herein simplify the complexity of preparing and handling multiple vials of drug product, which significantly reduces preparation time, addresses dosing-related challenges like weight-based preparation, reduces drug waste issues, and reduces risks associated sterility and contamination, among other benefits.