Pharmaceutical Container Assembly with Integrated Closed End

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Pharmaceutical compositions in existing container assemblies have limited shelf-lives due to leachables such as metal ions migrating from the container materials, particularly affecting biologics, and these containers have a bulky design with multiple components increasing manufacturing costs.

Innovation Solution

A container assembly with a closed end and optimized dimensions and material parameters, such as low Zn-leachability, reduces leachable migration and eliminates the need for a neck portion and crimp, resulting in a compact design with reduced component count and improved shelf-life.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a container assembly with open end and crimp closure is used, then the container can be easily assembled and disassembled, but leachables migrate from the container materials into the pharmaceutical composition reducing shelf-life

Engineering Contradiction:

Improveshelf-lifeVSAvoidleachable contamination

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention removes the crimp closure component from the container assembly. The container is designed with a closed end that is integrated into the container body itself, eliminating the need for a separate crimp closure that could contribute leachables to the pharmaceutical composition.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The container is made from materials with controlled leachability characteristics. The closed end is formed from the same material as the container body or from a material that is chemically compatible and minimizes leachable migration into the pharmaceutical composition.

Inventive Principle:

Principle #40Composite materials

2Ease of manufacture

If a container with neck portion and crimp is used, then the container can be sealed, but the design becomes bulky and manufacturing costs increase

Engineering Contradiction:

Improvemanufacturing costVSAvoidcomponent count

Core Design Contradiction:

Ease of manufactureVSDevice complexity

Solution Approach 1:

The invention merges the container body and closure into a single integrated structure. The closed end is formed as an integral part of the container body, eliminating the need for separate neck portion and crimp closure components, thereby reducing component count and simplifying manufacturing.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The container body serves multiple functions: it contains the pharmaceutical composition, provides structural support, and acts as its own closure mechanism through the integrated closed end, eliminating the need for separate closure components.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS11986636B2Containers having closed ends, container assemblies and medical devices having such containers

Publication Date: 2024.05.21 SCHOTT PHARMA SCHWEIZ AG

AI summary

Container assemblies for accommodating pharmaceutical compositions are provided. The container assembly includes a container and a plunger. The container has a hollow cylindrical body with an open end and a closed end, which is closed by a bottom portion. The hollow cylindrical body has a length (L), an outer diameter (DO), and an inner diameter with a length to outer diameter ratio between 3:1 and 15:1. The hollow cylindrical body and the bottom portion are formed integrally and of the same material, which is a glass or polymer material. The container has an inner surface with an average Zn-leachability of 0.00085 μg/cm2 or less. The plunger is inside the hollow cylindrical body at the open end, is pierceable by a cannula, and is slidable relative to the hollow cylindrical body from the open end towards the closed end.