Thermoformed Pharmaceutical Packaging with Pre-Stretched Application Channel

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Solution Overview

Problem

The existing methods for producing application packaging for liquid pharmaceutical products face challenges in maintaining dimensional accuracy of the application channel, leading to issues with liquid leakage and diffusion, especially when using active ingredients like fipronil, which is not compatible with all plastics and requires specific thermoforming films with precise thickness and structure.

Innovation Solution

The method involves using a forming die to pre-stretch and shape the deep-drawing film during the thermoforming process, ensuring precise dimensional accuracy of the application channel, and employing a thermal ring seal for a tight and long-term secure closure, along with interchangeable molds for different sizes and controlled heating to maintain material plasticization within optimal temperature ranges.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If the deep-drawing film is heated and plasticized for thermoforming, then the film becomes formable into the molded part, but the film thickness varies particularly when the film is plasticized and then deformed, leading to dimensional inaccuracy of the application channel

Engineering Contradiction:
Improveformability of deep-drawing filmVSAvoiddimensional accuracy of application channel
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent applies a preliminary action by pre-stretching the deep-drawing film in the application channel area before the main thermoforming process. This pre-stretching compensates for subsequent thickness variations during deformation, ensuring dimensional accuracy is maintained even after the film is plasticized and formed into the final molded part

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements local quality by applying different treatment to different areas of the deep-drawing film. Specifically, the application channel area receives pre-stretching and controlled heating to maintain precise thickness, while other areas of the film are allowed to undergo normal thermoforming without this additional control

Inventive Principle:
Principle #3Local quality

2Reliability

If the application channel has a small cross-section to prevent liquid escape, then the liquid pharmaceutical product remains contained, but the liquid may still leak or diffuse through the connection area between the cover film and thermoforming film

Engineering Contradiction:
Improvecontainment of liquid pharmaceutical productVSAvoidliquid leakage and diffusion
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary thermal ring seal between the cover film and the thermoforming film connection area. This thermal ring seal acts as a mediator that creates a tight sealing connection, preventing liquid pharmaceutical product from leaking or diffusing through the interface between the two films while maintaining the small cross-section of the application channel

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If the cover film is fixed to the thermoforming film for tight closure, then liquid and vapor tightness is achieved, but the connection must maintain integrity under long-term creep behavior of the liquid pharmaceutical product

Engineering Contradiction:
Improveliquid and vapor tightness of closureVSAvoidlong-term stability of connection
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent applies parameter changes by using thermal energy to alter the physical state of the connection area during sealing. The thermal ring seal heats the connection area to create a strong bond between the cover film and thermoforming film, and this thermal processing ensures the connection maintains its integrity under long-term creep conditions by creating a durable, heat-set seal

Inventive Principle:
Principle #35Parameter changes

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 approach ensures a reliably dimensionally accurate application channel that prevents liquid leakage and diffusion, maintaining the stability and effectiveness of the pharmaceutical product during storage and application, while accommodating different sizes and types of pets through interchangeable molds.

Implementation Method 1

a deep-drawing film made of thermoplastics laminated to one another is first heated in order to plasticize the deep-drawing film

Methodology Applied
Scientific EffectHeating: Heating

Implementation Method 2

heated in order to plasticize the deep-drawing film at least in partial areas

Methodology Applied
Scientific EffectPlasticization: Plasticity

Implementation Method 3

the plasticized deep-drawing film is shaped into deep-drawing molds designed as recesses in the mold, i.e. deep-drawn into them using a vacuum and/or blown air

Methodology Applied
Scientific EffectVacuum forming: Vacuum

Implementation Method 4

The cover film is bonded to the connection area of the thermoformed and filled thermoformed film by means of a thermal ring seal

Methodology Applied
Scientific EffectThermal sealing: Heating

Data Source

PatentEP2998098B1Method for making and filling an application packaging for a liquid pharmaceutical product
Publication Date: 2016.10.19 KLOCKE VERPACKUNGSSERVICE
  • EP2998098B1 patent drawingFigure 1A~1C
  • EP2998098B1 patent drawingFigure 2
  • EP2998098B1 patent drawingFigure 3~4

AI summary

The present invention relates to a method for manufacturing and filling an application package 1 for a liquid pharmaceutical product. A thermoformed film 3 made of laminated thermoplastic materials is heated to plasticize at least some of its regions 19. Plasticized regions of the thermoformed film 3 are thermoformed into a mold 12 to form a chamber 2 for the liquid pharmaceutical product and a cannula-like application channel 6 opening into this chamber 2. The chamber 2 and the application channel 6 are surrounded by a non-thermoformed, substantially flat connecting region 5 of the thermoformed film 3. The liquid pharmaceutical product is filled into the chamber 2 of the thermoformed film 3. The chamber 2 and the application channel 6 are sealed by covering the thermoformed and filled film 3 with a substantially flat cover film 4.The cover film 4 is fixed to the connection area 5 of the thermoforming film 3, which surrounds the chamber 2 and the application channel 6. During thermoforming, the thermoforming film 3 is pressed into the forming tool 12 by a forming die 24, at least in a partial area of ​​the application channel 6.