High-Density LDPE for Medical Packaging Sterilization

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Solution Overview

Problem

Current LDPE materials used in medical packaging for sterilization processes, such as the Blow-Fill-Seal process, face challenges with temperature resistance and melting points, leading to prolonged sterilization times and potential leakage issues, especially for sensitive substances like dextrose solutions.

Innovation Solution

A new LDPE material with higher density and crystallinity, achieved through radical polymerization, which has a higher melting temperature and maintains a high melt flow rate, allowing for faster and higher-temperature sterilization without compromising processability, and a novel manufacturing process involving a tubular reactor with specific peroxide initiators and chain transfer agents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Temperature

If LDPE material with higher density and crystallinity is used to increase melting temperature, then sterilization temperature can be increased and sterilization time reduced, but melt flow rate decreases and processability deteriorates

Engineering Contradiction:
Improvemelting temperatureVSAvoidprocessability
Core Design Contradiction:
TemperatureVSEase of manufacture

Solution Approach 1:

The patent applies parameter changes by precisely controlling the density of LDPE within the range of 0.930-0.940 g/cm³ and melt flow rate within 0.3-2.0 g/10min at 190°C. This optimization allows the material to achieve higher melting temperature (improving sterilization capability) while maintaining adequate processability for blow molding applications.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite material strategy by using LDPE as a base polymer and incorporating specific additives including antioxidants (e.g., BHT, TBHQ), UV stabilizers (e.g., hindered amine light stabilizers), and nucleating agents. These additives enhance the base polymer's thermal stability and crystallinity without significantly compromising its processability, effectively creating a composite material system that resolves the contradiction between melting temperature and processability.

Inventive Principle:
Principle #40Composite materials

2Productivity

If sterilization temperature is increased to reduce sterilization time, then manufacturing efficiency improves, but material integrity may be compromised due to leakage

Engineering Contradiction:
Improvesterilization speedVSAvoidbottle integrity
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent utilizes parameter changes by optimizing the density range (0.930-0.940 g/cm³) and melt flow rate (0.3-2.0 g/10min) to achieve a melting temperature that enables sterilization at 115-121°C without causing bottle deformation or leakage. This parameter optimization allows faster sterilization cycles while maintaining material integrity and reliability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies beforehand cushioning by incorporating antioxidants (e.g., butylated hydroxytoluene, tert-butylhydroquinone) and stabilizers into the LDPE formulation before sterilization. These additives pre-protect the polymer chains from thermal degradation and oxidation during the high-temperature sterilization process, preventing material breakdown and ensuring bottle integrity even at elevated sterilization temperatures.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Ease of manufacture

If LDPE material with current properties is used, then good processability is maintained, but sterilization time must be extended and temperature limited

Engineering Contradiction:
ImproveprocessabilityVSAvoidsterilization time
Core Design Contradiction:
Ease of manufactureVSLoss of time

Solution Approach 1:

The patent applies parameter changes by carefully controlling the melt flow rate within 0.3-2.0 g/10min at 190°C and density within 0.930-0.940 g/cm³. This optimization enables the material to maintain adequate processability for blow molding while achieving higher melting temperature that allows sterilization at 115-121°C, significantly reducing sterilization time compared to conventional LDPE materials.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies preliminary action by incorporating nucleating agents and stabilizers into the LDPE formulation before processing. These additives pre-establish the crystalline structure and thermal stability of the polymer, enabling faster heating rates and shorter sterilization times without sacrificing processability. The nucleating agents promote rapid and uniform crystallization, reducing the time needed to achieve the desired sterilization effect.

Inventive Principle:
Principle #10Preliminary action

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 new LDPE material significantly reduces sterilization time by up to 60% while ensuring the integrity of sealed bottles and improving processing ease, enabling efficient production of sterilizable medical packaging.

Implementation Method 1

adding to a tubular reactor having at least three consecutive reactor zones as defined by the number of reagent inlets available, preferably to a tubular reactor having just three reactor zones, at a first inlet for the first reactor zone a peroxide mixture comprising at least one first peroxide having a half-time of decay of 0.1 hr at 105° C.

Methodology Applied
Scientific EffectPeroxide decomposition: Decomposition (biological)

Implementation Method 2

conducting high-pressure polymerization of ethylene by I. adding to a tubular reactor having at least three consecutive reactor zones as defined by the number of reagent inlets available

Methodology Applied
Scientific EffectRadical polymerization: Photopolymerisation

Implementation Method 3

adding a chain transfer agent to said reactor at any further inlet available, said chain transfer agent being selected from the group consisting of C3 to C10 aldehyde or alkane, preferably a C3 to C15 alkane comprising a tertiary or secondary C—H group

Methodology Applied
Scientific EffectChain transfer:

Implementation Method 4

having at least three consecutive reactor zones as defined by the number of reagent inlets available

Methodology Applied
Scientific EffectThermal heating: Heating

Implementation Method 5

conducting high-pressure polymerization of ethylene

Methodology Applied
Scientific EffectHigh pressure compression: Compression

Data Source

PatentUS8969501B2High pressure LDPE for medical applications
Publication Date: 2015.03.03 BASELL POLYOLEFINE GMBH
  • US8969501B2 patent drawing
  • US8969501B2 patent drawing
  • US8969501B2 patent drawing

AI summary

A novel LDPE from radical, high pressure polymerization is devised.