Artificial Lyo-Vials With Durable Cakes for Automated Visual Inspection
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Solution Overview
Problem
Automated visual inspection systems for lyophilized pharmaceutical products face challenges in reliably and repeatedly inspecting lyophilized product cakes due to their short structural lifetime, leading to increased costs and delays in development and testing.
Innovation Solution
The creation of artificial lyophilized product cakes and modified vials using 3D printing and coating techniques to replicate defects such as high fill, low fill, collapsed cake, meltback, and foreign particles, allowing for consistent and reliable training and qualification of AVI systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If real lyophilized product samples are used for AVI system testing and tuning, then the inspection accuracy and system qualification are improved, but the structural lifetime of the samples is short due to agitation exposure, requiring frequent replacement and increasing costs and delays
Solution Approach 1:
The patent creates artificial lyophilized product cakes that replicate the visual characteristics and defect types of real lyophilized products. These artificial samples are made from durable materials that can withstand repeated handling and agitation without degrading. The artificial cakes include realistic defects such as low fill, high fill, collapsed cake, meltback, and foreign particles, allowing AVI systems to be trained and qualified with indefinite reuse, eliminating the need for frequent sample replacement while maintaining inspection accuracy.
2Reliability
If new lyophilized product samples are manufactured repeatedly for AVI system testing, then adequate test samples are available, but the manufacturing cost and development time increase significantly
Solution Approach 1:
The artificial lyophilized product cakes provide a reusable alternative to manufacturing new real samples repeatedly. Once the artificial samples are created with various defect types, they can be used indefinitely for AVI system testing, training, and qualification. This eliminates the continuous cycle of manufacturing new samples, reducing both manufacturing costs and development time while ensuring consistent sample availability for reliable system testing.
3Manufacturing precision
If manufacturing processes are used to create lyo-cakes with specific defects for AVI training, then realistic defect samples are produced, but the manufacturing complexity and cost increase
Solution Approach 1:
The artificial lyophilized product cakes are manufactured using simplified processes that directly create the desired defect characteristics without requiring complex lyophilization cycles. The artificial cakes can be produced with embedded defects such as low fill, high fill, collapsed cake, meltback, and foreign particles through straightforward manufacturing techniques. This reduces manufacturing complexity and cost while maintaining the ability to produce realistic defect samples for comprehensive AVI system training and qualification.
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 artificial lyophilized product cakes and vials provide robust samples that can survive shipping and facilitate the development of new inspection techniques, reducing costs and delays by making defect samples available consistently and reliably.
Implementation Method 1
controlling material discharge from a material discharge device of the three-dimension printer, to dispense a material, based on at least z-values of the three-dimensional data
Implementation Method 2
At least a portion of the vial wall is translucent
Data Source
AI summary
Artificial lyo-vials are provided that include a portion of a vial. The portion of the vial includes a vial wall with a top end opening and a bottom end opening. The bottom end opening includes an inside diameter that is greater than an inside diameter of the top end opening. At least a portion of the vial wall is translucent. The artificial lyo-vials include an artificial lyo-cake. The artificial lyo-cake is secured within the portion of the vial. The artificial lyo-cake includes a base, an annular surface, a top surface, and a longitudinal dimension extending from the base to at least a portion of the top surface. An outside diameter of the artificial lyo-cake is greater than the inside diameter of the top end opening.


