Primary Packaging with Integrated Septum Injection Molding

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Solution Overview

Problem

Current primary packaging means with integrated septums, particularly made of glass, are prone to breakage, leading to high production costs and compatibility issues with devices like auto-injectors and infusion pumps, and require additional assembly steps and complex hardening processes.

Innovation Solution

A method and device for producing primary packaging means with an integrated septum using injection molding, where the septum is preloaded and encapsulated between moving mold halves, ensuring prestressing and secure attachment without a crimped socket, using plastics like cycloolefin polymers for enhanced durability and compatibility with standard filling systems.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If glass is used for primary packaging with integrated septum, then sterility and chemical inertness are improved, but breakage resistance and manufacturing cost are worsened

Engineering Contradiction:
ImprovesterilityVSAvoidbreakage resistance
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent changes the material parameter from glass to plastic (specifically polypropylene or similar biocompatible plastics), transforming the primary packaging from fragile to durable while maintaining sterility through the same septum integration approach. This material substitution resolves the contradiction between sterility and breakage resistance.

Inventive Principle:
Principle #35Parameter changes

2Manufacturing precision

If glass manufacturing tolerances are applied, then production precision is improved, but production cost and device compatibility are worsened

Engineering Contradiction:
Improvedimensional toleranceVSAvoidproduction cost
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The patent changes the manufacturing process parameter from glass blowing/molding to plastic injection molding, which inherently provides tighter dimensional tolerances and better repeatability. This process transformation reduces production costs by eliminating the need for post-manufacturing sorting and selection while improving device compatibility.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If additional assembly steps are used to attach septum to glass, then sealing reliability is improved, but manufacturing complexity and time are worsened

Engineering Contradiction:
Improvesealing reliabilityVSAvoidassembly steps
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the septum attachment process with the primary packaging manufacturing process by integrating the septum into the injection mold cavity. The septum is positioned in the mold before injection, and the plastic material is injected around it, creating a monolithic structure where the septum is permanently sealed to the packaging in a single manufacturing step, eliminating separate crimping or attachment operations.

Inventive Principle:
Principle #5Merging (Combining)

4Adaptability or versatility

If custom filling lines are developed for plastic primary packaging, then compatibility with plastic material is improved, but investment cost and delivery time are worsened

Engineering Contradiction:
Improvecompatibility with plasticVSAvoidinvestment cost
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The patent designs the plastic primary packaging with standardized dimensions and interface features that are compatible with existing glass cartridge filling lines. The packaging maintains universal adaptability by fitting into current automated filling and processing equipment, eliminating the need for costly custom line development while still optimizing for plastic material properties.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 method produces unbreakable primary packaging with low tolerance ranges, reducing production costs, minimizing material waste, and ensuring interface compatibility with devices, while maintaining the sterility and flow properties of glass cartridges.

Implementation Method 1

Injecting material into the cavity of the injection mold via an injection port in one of the mold halves of the injection mold, wherein the septum (between the two mold halves of the injection mold) is held under tension by them and an edge of the septum is overmolded by the material

Methodology Applied
Scientific EffectInjection molding:

Implementation Method 2

Cooling the injected material while maintaining holding pressure, thereby forming the primary packaging with integrated septum to be produced

Methodology Applied
Scientific EffectCooling: Cooling

Data Source

PatentEP3446849B1Method and device for producing a primary package with integrated septum and primary packaging with integrated septum
Publication Date: 2021.09.29 GERRESHEIMER REGENSBURGH GMBH
  • EP3446849B1 patent drawingFigure 1a~1c
  • EP3446849B1 patent drawingFigure 1d~1f
  • EP3446849B1 patent drawingFigure 2a~2c

AI summary

The invention relates to a method for manufacturing a primary packaging material (1, 101, 201) with an integrated septum (2, 102, 202), characterized by the following method steps: a) providing a septum (2, 102, 202), b) providing an injection mold (3, 103, 203) with two mold halves (4, 5; 104, 105; 204, 205) that are movable relative to each other, c) positioning the septum (2, 102, 202) in the injection mold (3, 103, 203), d) moving the two mold halves (4, 5; 104, 105; 204, 205) of the injection mold (3, 103, 203) such that one of the geometry of the primary packaging material to be manufactured (1, 101, 202) is formed. 201) corresponding cavity (6, 106, 206) is formed, e) Injecting a material into the cavity (6, 106, 206) of the injection mold (3, 103, 203) via an injection port (7, 107, 207) in one of the mold halves (4, 5; 104, 105; 204, 205) of the injection mold (3, 103, 203), wherein the septum (2, 102, 202) between the two mold halves (4, 5;104, 105; 204, 205) of the injection mold (3, 103, 203) are held under preload by these and an edge (11, 111, 211) of the septum (2, 102, 202) is overmolded by the material, wherein an area of ​​the septum (2, 102, 202) which is contacted by both mold halves (4, 5; 104, 105; 204, 205) remains free of material. f) Cooling the injected material while maintaining holding pressure, whereby the primary packaging material (1, 101, 201) with integrated septum (2, 102, 202) is formed, g) Moving the two tool halves (4, 5; 104, 105; 204, 205) of the injection mold (3, 103, 203) such that the produced primary packaging material (1, 101, 201) with integrated septum (2, 102, 202) can be removed from the injection mold (3, 103, 203), and h) Removing the produced primary packaging material (1, 101, 201) with integrated septum (2, 102, 202) from the injection mold (3, 103, 203).