Rotating Edge Filtration Device for API Delumping

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing devices for filtering and processing active pharmaceutical ingredients (APIs) face challenges in breaking up agglomerates and achieving desired particle sizes and morphologies, which are crucial for bioavailability and drug product formulation.

Innovation Solution

A filtration device with a rotating edge featuring protrusions that sweep the filtration medium, breaking up agglomerates and delumping APIs, combined with a method that involves rotating an impeller with fins to promote the breakup of API particles during filtration and drying processes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional filtration devices are used, then filtration is achieved, but agglomerates are not effectively broken up and particle size reduction is insufficient

Engineering Contradiction:

Improveparticle sizeVSAvoiddelumping efficiency

Core Design Contradiction:

Manufacturing precisionVSProductivity

Solution Approach 1:

The impeller is segmented into multiple fins with protrusions that create localized mechanical action zones. Each fin acts as an independent delumping element, collectively providing comprehensive particle size reduction across the entire filtration area without requiring a single complex mechanism

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The impeller rotates at controlled speeds (typically 50-500 rpm) to dynamically adjust the mechanical action intensity. This dynamic operation allows the protrusions to sweep across the filtration medium with varying force, effectively breaking up agglomerates of different sizes and maintaining flexibility in processing different API materials

Inventive Principle:

Principle #15Dynamics

2Manufacturing precision

If mechanical processing is intensified to achieve desired particle size, then particle size reduction improves, but API crystallinity and morphology may deteriorate

Engineering Contradiction:

Improveparticle sizeVSAvoidcrystallinity

Core Design Contradiction:

Manufacturing precisionVSStability of the object's composition

Solution Approach 1:

The protrusions apply partial mechanical action only where needed on the filtration medium surface. By sweeping across the cake layer rather than continuously agitating the entire bulk material, the system achieves sufficient particle size reduction while minimizing excessive mechanical stress that could damage crystal structures

Inventive Principle:

Principle #16Partial or excessive action

Solution Approach 2:

The mechanical delumping action is localized to specific zones where protrusions contact the filtration medium. This localized quality control ensures that particle size reduction occurs at the cake surface while the bulk material retains its crystalline structure, preventing uniform degradation throughout the entire API mass

Inventive Principle:

Principle #3Local quality

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

The solution effectively delumps and processes APIs to achieve the desired particle size and morphology, ensuring bioavailability and suitable properties for drug formulation, as demonstrated by the successful processing of Ciprofloxacin hydrochloride monohydrate, meeting USP specifications for lattice water content and maintaining crystallinity.

Implementation Method 1

a rotating edge (which may be part of a fin of an impeller) that comprises a plurality of protrusions extending from it. The protrusions may be arranged such that they aid in the breakup of agglomerates and/or crystals of API when the edge sweeps the facial area of the filtration medium

Methodology Applied

Scientific EffectMechanical Force: Mechanical Force