Non-Polymeric Coated Metal Substrate for Corrosion Resistance
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Solution Overview
Problem
Current pharmaceutical manufacturing processes face challenges with material accumulation, bacterial growth, and corrosion issues, particularly with the use of high concentrations of guanidine hydrochloride, which can attack stainless steel, and are limited by ASME-BPE standards that restrict the use of non-polymeric coatings with additional properties.
Innovation Solution
A pharmaceutical manufacturing process involving a non-polymeric coating on a metal substrate that includes silicon, oxygen, and carbon, allowing for the use of stainless steel and enabling operation with corrosive agents like guanidine hydrochloride without corrosion, while expanding the range of compatible materials and conditions beyond ASME-BPE standards.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high concentration guanidine hydrochloride is used for cleaning, then cleaning effectiveness is improved, but corrosion of stainless steel occurs
Solution Approach 1:
A non-polymeric coating layer is applied as an intermediary between the stainless steel substrate and the corrosive guanidine hydrochloride cleaning solution. This coating acts as a protective barrier that allows the use of high-concentration cleaning agents without direct contact with the metal substrate, thus maintaining cleaning effectiveness while preventing corrosion.
Solution Approach 2:
The system uses a composite structure consisting of a stainless steel substrate combined with a non-polymeric coating layer. This composite material approach allows the benefits of both materials: the mechanical strength and thermal properties of stainless steel combined with the chemical resistance of the non-polymeric coating against guanidine hydrochloride.
2Reliability
If ASME-BPE standards are followed, then material safety is improved, but use of non-polymeric coatings with additional properties is prevented
Solution Approach 1:
The invention changes the material parameter by introducing non-polymeric coatings that are not traditionally permitted under ASME-BPE standards. These coatings modify the surface properties of the stainless steel, providing additional functional benefits such as enhanced chemical resistance, reduced protein adhesion, or improved cleaning characteristics while maintaining the underlying safety of the stainless steel substrate.
3Strength
If stainless steel is used in contact with corrosive agents, then structural strength is maintained, but corrosion resistance deteriorates
Solution Approach 1:
The non-polymeric coating serves as a mediator that protects the stainless steel substrate from corrosive agents. This allows the system to maintain the structural strength advantages of stainless steel while eliminating its vulnerability to corrosion from aggressive cleaning chemicals through the protective barrier function of the coating.
Data Source
AI summary
Pharmaceutical manufacturing processes and products are disclosed. A pharmaceutical manufacturing process includes flowing a liquid through a pathway. The liquid contacts a non-polymeric coating on a substrate within the pathway. The substrate is a metal or metallic substrate. A pharmaceutical product is produced by flowing a liquid through a pathway. The liquid contacts a non-polymeric coating on a substrate within the pathway. The substrate is a metal or metallic substrate.