Purgeable Fill Needle With Robotic Aseptic Handling
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current controlled environment enclosures require human intervention via gloves for pharmaceutical fluid handling, leading to risks of puncture and contamination, especially when dealing with expensive and precise pharmaceuticals that demand aseptic dispensing at precise volumes.
Innovation Solution
A method and apparatus utilizing a robotic arm manipulation system for installing, protecting, and unprotecting fluid paths within controlled environment enclosures, allowing for automated and aseptic handling of pharmaceutical fluids without the need for gloves, including decontamination and fluid transfer processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If gloves are used for manual manipulation of equipment in controlled environment enclosures, then human intervention is enabled, but the risk of puncture and contamination increases
Solution Approach 1:
The patent replaces manual mechanical manipulation through gloves with an automated robotic arm system. The robotic arm is equipped with specialized end effectors that can manipulate fill needles and fluid paths without requiring human operators to wear gloves, thereby eliminating the puncture risk while maintaining operational capability.
Solution Approach 2:
The patent introduces a robotic arm as an intermediary between the human operator and the controlled environment enclosure. This intermediary performs all manual manipulation tasks inside the enclosure, allowing humans to remain outside the controlled environment entirely, thus eliminating both puncture risk and potential contamination from glove material.
2Ease of operation
If flexible tubing materials are used for fluid paths in controlled environment enclosures, then installation and manipulation is easier, but gas permeability increases leading to contamination
Solution Approach 1:
The patent applies different material properties to different sections of the fluid path system. Flexible tubing is used in sections where manipulation is required, while rigid or gas-impermeable materials are used in sections where gas diffusion must be prevented. This localized application of different material qualities allows the system to benefit from both flexibility and gas barrier properties.
Solution Approach 2:
The patent employs composite construction for fluid path components, combining materials with different properties. For example, multi-layer tubing structures are used that integrate flexible polymer layers with gas-barrier layers, achieving both ease of manipulation and resistance to gas diffusion simultaneously.
3Productivity
If automated equipment is placed in controlled environment enclosures, then productivity increases, but the equipment size and complexity prevent fully automatic operation
Solution Approach 1:
The patent divides the automated filling system into separate functional modules: a robotic arm for positioning and manipulation, a fill needle assembly for fluid transfer, and a container handling system. Each module can be independently controlled and optimized, allowing complex filling operations to be broken down into simpler, more reliably automated sub-tasks.
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
Enables the safe and precise aseptic dispensing of pharmaceutical fluids into containers within controlled environments, reducing contamination risks and minimizing fluid loss, while allowing for automated operation of equipment without human intervention, thus enhancing efficiency and safety.
Implementation Method 1
mechanically unprotecting the fluid path within the controlled environment enclosure. The mechanically unprotecting may be by a robotic arm manipulation system
Implementation Method 2
decontaminating the controlled environment enclosure automatically after the introducing the fluid path into the controlled environment enclosure
Implementation Method 3
decontaminated. This may be done thermally using steam or chemically using chemical agents
Implementation Method 4
enables the safe and precise aseptic dispensing of pharmaceutical fluids into containers
Implementation Method 5
a fill needle dispensing tip and a sealable unprotectable fill needle sheath defining a sealed volume within which the dispensing tip is disposed when the fill needle is protected by the fill needle sheath
Data Source
AI summary
The present invention involves a fill needle system for aseptically dispensing a pharmaceutical fluid in an aseptic chamber comprises a fill needle tubing in fluid communication with a pharmaceutical fluid source via flexible tubing and extending through a fill needle hub; a fill needle dispensing tip disposed at a dispensing end of the fill needle tubing; a fill needle sheath shaped and arranged to removably mate with and seal aseptically to the fill needle hub to form an aseptically sealed volume enclosing the dispensing tip; and a fluid pressure pulse induction system disposed and configured to compress the flexible tubing in order to dislodge droplets of pharmaceutical fluid retained on the dispensing tip after halting dispensing of the pharmaceutical fluid. An associated method of dispensing pharmaceutical fluid comprises operating the fluid pressure pulse induction system to dislodge the droplets. The system may comprise a controller for automatically controlling the dispensing and droplet dislodging.