Sterile Solid Filling and Sealing With Ionisation-Based Adhesion Control
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Solution Overview
Problem
The adherence of solid pharmaceutical substances such as powders, granules, pellets, and nanoparticles to the walls of containers during filling poses challenges in achieving airtight seals, leading to contamination, loss of doses, and non-compliance with Good Manufacturing Practices (GMPs due to adherence to container walls, which affects the integrity and precision of dosing.
Innovation Solution
A procedure involving the ionisation of both the pharmaceutical container and the solid substance, along with the ionisation of filling and capping equipment, to neutralise electrostatic charges, combined with controlling the nozzle height to prevent adherence to container walls, ensuring accurate filling and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If solid pharmaceutical substances are dispensed into containers, then dosing is achieved, but the solids adhere to the container walls preventing airtight sealing
Solution Approach 1:
The patent changes the electrostatic charge parameter of both the container and the solid substance by applying ionisation treatment. This modifies the electrical properties of the surfaces to eliminate electrostatic attraction, thereby preventing adhesion while maintaining dosing precision and enabling proper sealing
Solution Approach 2:
The patent converts the harmful electrostatic adhesion effect into a beneficial neutral state by introducing ionisation. The same electrostatic forces that cause adhesion are neutralised by introducing opposite charges through ionisation, transforming the problem into a solution that maintains dosing accuracy while enabling sealing
2Productivity
If solids are dispensed into containers, then filling is achieved, but contamination occurs due to adherence to sealing area walls
Solution Approach 1:
The patent modifies the electrostatic charge parameter of the container and solid substance through ionisation, changing the physical-chemical properties to eliminate adhesion. This prevents contamination in the sealing area while maintaining efficient filling operations
Solution Approach 2:
The patent introduces ionisation as an intermediary process between dispensing and sealing. This intermediate treatment neutralises electrostatic charges, creating a transition state that prevents adhesion and contamination while allowing the filling process to proceed efficiently
3Reliability
If ionisation is applied to prevent adhesion, then sealing integrity is improved, but process complexity increases
Solution Approach 1:
The patent replaces potential mechanical approaches to preventing adhesion with an electrostatic field-based ionisation system. This substitution uses electrical fields rather than mechanical means to achieve adhesion prevention, resulting in a more efficient and controllable solution despite the introduction of electrical equipment
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 method ensures precise dosing and airtight sealing, preventing contamination and adherence, thereby maintaining the integrity and quality of pharmaceutical products, adhering to GMP standards.
Implementation Method 1
ionisation of both the pharmaceutical container and the solid substance, along with the ionisation of filling and capping equipment, to neutralise electrostatic charges
Data Source
Figure 1(a)~1(d)
Figure 2(a)~2(d)
Figure 3(a)~3(d)
AI summary
A sterile procedure for the filling of solids in pharmaceutical containers and the sealing thereof under sterile conditions; among these being syringes, vials, capsules, ampoules, single-dose devices or cartridges filled with solid substances selected from the group formed by powder granules, pellets, nanoparticles or microparticles, obtaining the airtightness of said containers. More specifically, the procedure achieves the avoidance of the adherence of the aforementioned substances to the sides of the pharmaceutical containers, thus ensuring the airtightness of the seal of the container and likewise the exactitude of the weight of solid dispensed into the container.