Pharmaceutical Holding Device Surface Roughness for Particle Control
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Solution Overview
Problem
Existing pharmaceutical and cosmetic packaging containers face issues with burrs and particle generation due to mold processes, which can lead to contamination and quality control challenges, and there is a need for improved nested solutions that enhance patient safety and reduce particle load.
Innovation Solution
A holding device with a plate-shaped carrier element and receptacles designed to accommodate primary packaging containers, where at least 50% of the receptacles have a total roughness profile of not more than 0.50 mm, minimizing burrs and reducing particle generation during handling and transport.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If injection molding is used to produce nests, then manufacturing efficiency is improved, but burrs and scratches are generated on the nest surfaces
Solution Approach 1:
The patent applies local quality by differentiating the surface treatment requirements for different regions of the nest. The receptacle interiors are given smooth finishes to prevent particle generation, while the exterior surfaces may have different characteristics. This localized approach allows the nest to meet particle generation requirements at critical interfaces without compromising overall structural integrity or manufacturing efficiency.
Solution Approach 2:
The patent implements preliminary action by incorporating surface quality control measures during the injection molding process itself, rather than addressing burrs and scratches after manufacturing. This includes optimizing molding parameters, using appropriate mold materials, and implementing in-process surface treatment techniques to prevent defect formation before the nest is completed, thereby maintaining both productivity and surface quality.
2Manufacturing precision
If deburring post-treatment is applied to nests, then surface quality is improved, but particle generation increases during handling and transport
Solution Approach 1:
The patent applies the extraction principle by removing and eliminating the problematic post-treatment step that causes particle generation. Instead of applying deburring treatments after molding, the invention extracts this harmful process entirely and replaces it with mold design modifications and in-process surface control techniques that achieve the same surface quality improvement without generating particles during handling and transport.
Solution Approach 2:
The patent implements preliminary action by addressing surface quality issues during the molding process itself rather than through subsequent post-treatment. This includes optimizing injection parameters, using appropriate mold materials, and incorporating surface treatment techniques that prevent burr formation before the nest is completed, thereby avoiding particle generation during later handling operations.
3Ease of operation
If multiple pushers are used to detach the nest from the mold, then the nest is pushed horizontally, but stress marks and scratches are created on the nest
Solution Approach 1:
The patent applies the extraction principle by removing the multiple pushers that cause stress marks and scratches. Instead, the invention uses alternative detachment mechanisms such as integrated ejection channels, tapered mold parts, or automated robotic handling that achieve horizontal alignment without contacting the nest surface with multiple pushers, thereby preventing surface defects.
Solution Approach 2:
The patent replaces the mechanical pusher system with alternative detachment mechanisms that do not create surface defects. This could include using the mold's own structure to guide the nest out horizontally, employing automated robotic grippers that contact the nest at safe points, or using thermal or chemical assistance to facilitate defect-free detachment while maintaining horizontal alignment.
4Reliability
If exhaust openings are provided in the mold, then air is released during injection, but burrs are generated on the nest
Solution Approach 1:
The patent applies local quality by positioning exhaust openings at specific locations where they are most effective for air release but least harmful to surface quality. This includes placing exhaust channels in regions away from critical receptacle interfaces, using covered exhaust openings that close during molding, or positioning them where any resulting burrs do not interfere with the nest's function or cause particle generation during handling.
Data Source
AI summary
A holding device, for holding a plurality of primary packaging containers for pharmaceutical, medical, or cosmetic compositions, includes: a plate-shaped carrier element which includes a plurality of through-holes; a plurality of receptacles, each being configured for accommodating a respective one of the plurality of primary packaging containers, each of the plurality of receptacles including a longitudinal direction and a receptacle wall which partially encloses a receptacle interior and forms a wall body, the wall body extending in the longitudinal direction through a respective one of the plurality of through-holes and, for each of the plurality of receptacles, having an interior surface which faces the receptacle interior and an exterior surface which faces opposite to the interior surface, at least 50% of respective ones of the plurality of receptacles having a maximum total height Rt of a roughness profile of the interior surface which is not more than 0.50 mm.


