Thermal Spray Coating for Pharmaceutical Chamber Components

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Solution Overview

Problem

Existing methods for manufacturing components for pharmaceutical production and packaging equipment are inefficient as they require large quantities of coating material, which is applied to both external and internal surfaces, leading to damage during hydrogen peroxide vapor sterilization treatments and increased downtimes due to the need for preemptive disassembly.

Innovation Solution

A method involving thermal spray treatment using solid powders accelerated in a supersonic gaseous jet to apply a corrosion-resistant coating only on the external surfaces of components made from materials like aluminum, magnesium, or their alloys, allowing them to withstand decontamination and sterilization treatments without oxidation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If components are coated with painting, anodizing, or galvanic coatings to protect against hydrogen peroxide vapor sterilization, then the components can withstand decontamination treatments, but large quantities of coating material are required and the coating is applied to internal surfaces that do not need protection

Engineering Contradiction:
Improveresistance to decontamination and sterilization treatmentsVSAvoidquantity of coating material
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The thermal spray coating is applied selectively only to the external surfaces of the components that are exposed to the hydrogen peroxide vapor sterilization environment, while the internal surfaces remain uncoated. This local application approach reduces the total quantity of coating material required while maintaining protection where it is most needed - on the surfaces that contact the sterilization agents.

Inventive Principle:
Principle #3Local quality

2Reliability

If components are coated with painting, anodizing, or galvanic coatings to protect against hydrogen peroxide vapor sterilization, then the components can withstand decontamination treatments, but the components become heavy

Engineering Contradiction:
Improveresistance to decontamination and sterilization treatmentsVSAvoidweight of components
Core Design Contradiction:
ReliabilityVSWeight of stationary object

Solution Approach 1:

By applying the protective coating only to the external surfaces rather than the entire component including internal surfaces, the overall weight of the component is reduced. The coating is concentrated only where it provides functional protection against the sterilization environment.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The invention uses composite construction by combining a base component material (such as aluminum, magnesium, or their alloys) with a protective coating material applied via thermal spray. This composite approach provides the necessary corrosion and oxidation resistance from the coating while maintaining the lightweight properties of the base material.

Inventive Principle:
Principle #40Composite materials

3Reliability

If equipment is disassembled and coated surfaces are covered before sterilization treatments, then the coating is protected from damage, but machine downtime increases

Engineering Contradiction:
Improveprotection of coating from damageVSAvoidmachine downtime
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The protective coating is applied to the external surfaces of the components before they are installed in the equipment and before the sterilization treatments begin. This preliminary coating application ensures that the surfaces are already protected when the sterilization process starts, eliminating the need for disassembly and covering operations.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The coating is designed to be self-protecting, allowing the sterilization treatments to be applied directly to the coated surfaces without requiring disassembly or protective covering. The coating itself serves as the protective barrier during the sterilization process, enabling the equipment to serve itself without external intervention.

Inventive Principle:
Principle #25Self-service

4Reliability

If hydrogen peroxide vapor is used for sterilization treatments, then effective bactericidal, sporicidal and fungicidal action is achieved, but the oxidizing power damages the surfaces of the equipment

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidoxidation damage to equipment surfaces
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The thermal spray coating acts as an intermediary protective layer between the hydrogen peroxide vapor sterilization agent and the base component surfaces. This intermediate coating absorbs the oxidizing action, protecting the underlying equipment surfaces from direct exposure to the harmful sterilization chemicals while allowing the sterilization process to proceed effectively.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 method reduces the need for extensive coating, prevents surface damage during hydrogen peroxide vapor treatments, and allows for repeated decontamination without disassembly, thereby saving time and manpower by ensuring effective sterilization of all exposed surfaces.

Implementation Method 1

subject the component to a thermal spray treatment using solid powders of a second material, accelerated in a supersonic gaseous jet

Methodology Applied
Scientific EffectThermal spray:

Implementation Method 2

accelerated in a supersonic gaseous jet

Methodology Applied
Scientific EffectSupersonic jet acceleration:

Implementation Method 3

treatments that use hydrogen peroxide vapor, which, however, while having a highly effective bactericidal, sporicidal and fungicidal action, has a high oxidizing power

Methodology Applied
Scientific EffectHydrogen peroxide oxidation: Oxidation

Implementation Method 4

it is known to subject these chambers to treatments that use hydrogen peroxide vapor

Methodology Applied
Scientific EffectVapor phase hydrogen peroxide sterilization: Hydrogen Peroxide

Data Source

PatentUS11932945B2Method to manufacture a component for a machine for the production and/or packaging of pharmaceutical products
Publication Date: 2024.03.19 IMA IND MASCH AUTOMATICHE SPA
  • US11932945B2 patent drawing
  • US11932945B2 patent drawing

AI summary

Method to manufacture a component suitable to be installed inside a protected chamber with a controlled atmosphere of a machine for the production and/or packaging of pharmaceutical products, configured to receive one or more pieces of equipment, or devices, or elements, each formed by one or more of the components, wherein the interior of the chamber, that is to say, the components that form the equipment, or the devices, or the elements, is/are intended to be subjected to suitable decontamination and sterilization treatments, for example CIP (Clean-In-Place) treatments and/or SIP (Sterilizing-In-Place) treatments; There are also described components that are manufactured with the manufacturing method as above, and a method to prepare a protected chamber, isolated from the external environment, of a machine for the production and/or packaging of pharmaceutical products.