Moisture Barrier Packaging for Biopharmaceutical Salt Storage

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Solution Overview

Problem

The caking of salts used in biopharmaceutical manufacturing due to moisture, which existing solutions like anti-caking agents and moisture-permeable bags with desiccants have not fully addressed, as they can contaminate products or be difficult to empty and maintain product integrity.

Innovation Solution

A package system comprising a gas and moisture-permeable inner bag surrounded by a gas and moisture-impermeable outer bag, with a desiccant compartment that absorbs moisture and prevents external moisture entry, allowing for continuous moisture removal and direct dispensing while maintaining product sterility and free-flowing characteristics.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If anti-caking agents are added to prevent caking, then caking is reduced, but product contamination occurs

Engineering Contradiction:
Improvecaking preventionVSAvoidproduct contamination
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The harmful anti-caking agents are extracted and removed from the system. Instead, a moisture barrier packaging system is used that physically prevents moisture ingress, eliminating the need for chemical additives that could contaminate the pharmaceutical product.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

A moisture barrier layer acts as an intermediary between the external environment and the salt product. This barrier (such as a foil lining or coated drum surface) prevents moisture from reaching the salts without requiring any chemical agents to be added to the product itself.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If moisture-permeable bags with desiccants are used to remove moisture, then caking is prevented, but the package becomes difficult to empty and expensive

Engineering Contradiction:
Improvecaking preventionVSAvoidpackage emptying difficulty
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The complex desiccant system is extracted and replaced with a simpler moisture barrier approach. The drum is lined with a moisture barrier material that passively prevents moisture ingress without requiring active desiccants, making the drum easier to clean and empty.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

Instead of using expensive, complex desiccant systems that are difficult to remove, the invention uses a disposable or easily replaceable moisture barrier liner that simplifies the overall system and reduces costs associated with drum cleaning and maintenance.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Reliability

If moisture-permeable bags with desiccants are used to remove moisture, then caking is prevented, but manufacturing cost increases

Engineering Contradiction:
Improvecaking preventionVSAvoidmanufacturing cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The expensive desiccant system is extracted and replaced with a cost-effective moisture barrier lining. This approach uses simpler, cheaper materials that provide the same protective function without the added complexity and cost of desiccant packets or chambers.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

A thin film moisture barrier lining is applied to the drum interior, providing effective moisture protection at low cost. This flexible barrier is easier and cheaper to manufacture and install than rigid desiccant systems, reducing overall manufacturing costs while maintaining caking prevention.

Inventive Principle:
Principle #30Flexible shells and thin films

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 package system effectively prevents salt caking by maintaining optimal moisture levels, ensuring the product remains free-flowing and sterile, with easy dispensing and minimal risk of contamination, even under varying temperature conditions.

Implementation Method 1

The inner bag is formed from a gas and/or moisture permeable material

Methodology Applied
Scientific EffectPermeation: Permeation

Implementation Method 2

a desiccant or gas scavenging material disposed in the intermediate space

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Implementation Method 3

The outer bag is formed from a gas and/or moisture impermeable polymeric material

Methodology Applied
Scientific EffectImpermeability:

Data Source

PatentEP3122654B1Package system and method for inhibiting moisture entry
Publication Date: 2019.03.06 AVANTOR PERFORMANCE MATERIALS LLC
  • EP3122654B1 patent drawingFigure 1
  • EP3122654B1 patent drawingFigure 2
  • EP3122654B1 patent drawingFigure 3

AI summary

A package system for maintaining the physicochemical integrity of the contents of the package system that includes: an inner bag formed from a gas and/or moisture permeable material, an outer bag formed from an impermeable polymer material, a discharge port that provides access to the interior of the outer bag; and a desiccant or gas scavenging material. The first end of the outer bag sealingly surrounds the exterior wall of the discharge port. The second end of the inner bag is sealed closed and the desiccant or gas scavenging material is disposed in an isolated compartment. The second end of the outer bag is sealed closed to isolate the interior from the environment exterior to the package system.