Vial Carrier Retaining Protrusions for Lyophilization

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Solution Overview

Problem

Existing supporting structures for vials in lyophilization processes are inadequate as they do not allow free access to the bottoms of vials, leading to inefficient lyophilization, material abrasion, and require complex handling due to instability and friction issues, which increases processing time and costs.

Innovation Solution

A supporting structure with radially inward protrusions at the lower ends of apertures that support vials at their transition regions, allowing the bottoms to be freely accessible and reducing material abrasion, enabling direct contact with cooling surfaces and simplifying handling through self-centering and low-friction insertion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If supporting tongues are used to support vials, then vials can be supported during lyophilization, but the supporting tongues are not sufficiently stable for large and heavy vials and cause material abrasion

Engineering Contradiction:
Improvestability of supporting structureVSAvoidmaterial abrasion
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The supporting structure is divided into multiple supporting elements (supporting tongues or supporting fingers) distributed around the circumference of the receptacle. Each supporting element independently contacts the vial, distributing the load and providing stable support without causing excessive abrasion at any single point.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The supporting elements are positioned at specific locations around the receptacle circumference, with varying heights or lengths depending on the local requirements. This allows optimized support for different vial sizes and weights while maintaining stability and reducing abrasion through localized contact points.

Inventive Principle:
Principle #3Local quality

2Manufacturing precision

If tight tolerances are used to ensure vials are supported with play, then radial play is achieved, but the carrier warps in use due to temperature or humidity changes

Engineering Contradiction:
Improveradial play toleranceVSAvoidcarrier dimensional stability
Core Design Contradiction:
Manufacturing precisionVSStability of the object's composition

Solution Approach 1:

The supporting elements are designed with some degree of flexibility or adjustability, allowing them to adapt to dimensional changes in the carrier caused by temperature or humidity variations. This dynamic characteristic enables the maintaining of proper radial play despite environmental changes and carrier warping.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The supporting elements are pre-positioned with predetermined clearances and tolerances that account for expected carrier expansion or contraction under operational conditions. This preliminary design consideration ensures that radial play is maintained throughout the lyophilization process without requiring tight manufacturing tolerances.

Inventive Principle:
Principle #10Preliminary action

3Productivity

If vials are supported on the supporting structure, then they can be processed concurrently, but the necks of the vials are not freely accessible requiring lifting and special equipment

Engineering Contradiction:
Improveconcurrent processing capabilityVSAvoidaccessibility of vial necks
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The supporting structure is designed with receptacles that extend vertically, allowing vials to be supported in a vertical orientation. This dimensional arrangement enables concurrent processing of multiple vials while maintaining accessibility to both the bottoms (for cooling plate contact) and the necks (for processing operations) without requiring lifting.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Solution Approach 2:

The supporting structure serves multiple functions simultaneously: it supports vials during lyophilization, enables concurrent processing of multiple vials, and maintains accessibility to both bottoms and necks. This multi-functionality eliminates the need for separate handling equipment and simplifies the overall processing operation.

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

4Stability of the object's composition

If friction exists between vials and supporting means, then vials are held in place, but large forces are required to remove or insert vials causing uncontrolled warping or accidental falling

Engineering Contradiction:
Improvevial positioning stabilityVSAvoidinsertion and removal force
Core Design Contradiction:
Stability of the object's compositionVSForce

Solution Approach 1:

The supporting elements act as intermediaries between the vials and the processing system. They provide sufficient friction to hold vials in place during processing but are designed with appropriate clearance and geometry to allow easy insertion and removal with minimal force, preventing carrier warping or vial falling.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The supporting elements are designed with dynamic characteristics that allow them to engage and disengage smoothly. During insertion, the supporting elements can flex or move slightly to accommodate the vial, and during removal, they can be easily disengaged with minimal force, maintaining stability during processing while enabling easy handling.

Inventive Principle:
Principle #15Dynamics

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

This design facilitates efficient lyophilization by ensuring direct thermal contact, reducing material abrasion, and simplifying vial handling, thereby decreasing processing time and costs while maintaining vial integrity.

Implementation Method 1

A direct contact between a cooling plate and the bottoms of vials is important for an optimized, quick lyophilization process

Methodology Applied
Scientific EffectThermal conduction: Conduction (thermal)

Implementation Method 2

the bottoms of the vials are freely accessible from the underside of the supporting structure, which makes it possible to carry out a lyophilization process while the vials are supported on the supporting structure

Methodology Applied
Scientific EffectLyophilization: Freeze Drying

Data Source

PatentUS10703539B2Supporting structure for concurrently supporting a plurality of vials, use thereof and process for the treatment of such vials
Publication Date: 2020.07.07 SCHOTT PHARMA AG & CO KGAA
  • US10703539B2 patent drawing
  • US10703539B2 patent drawing
  • US10703539B2 patent drawing

AI summary

A supporting structure for concurrently supporting a plurality of vials is provided. The supporting structure includes a carrier having apertures or receptacles, into which the vials can be inserted to be supported therein on the carrier. The vials have a bottom that forms a base, a cylindrical side wall, and an annular transition region between the base and the cylindrical side wall. The carrier has a retaining protrusion at a lower end of the aperture or receptacle that extends into the respective aperture or receptacle inward in radial direction. The retaining protrusion supports the vial in cooperation with the transition region outside the base in such a manner that the bottoms or bases of the vials jut out of the apertures or receptacles of the carrier and are freely accessible from the lower side of the carrier.