COP/COC Prefilled Syringe Assembly for EtO pH Stability
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Solution Overview
Problem
Plastic syringes used for prefilled sterilization-sensitive fluids like saline and heparinized saline experience undesirable pH shifts due to ethylene oxide (EtO) gas sterilization, leading to composition changes and the formation of toxic byproducts, while glass syringes are fragile and costly, and existing solutions like separate packaging or additional sterilization processes are inefficient and costly.
Innovation Solution
A syringe assembly made from cyclic olefin polymer (COP) or cyclic olefin copolymer (COC) with a high gas impermeability barrier, combined with a plunger and tip cap made from materials like polypropylene and butyl rubber, prevents EtO ingress, maintaining solution pH within acceptable ranges and adhering to FDA and USP standards during sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If plastic syringes are used for prefilled sterilization-sensitive fluids and subjected to EtO gas sterilization, then sterilization is achieved, but pH shifts occur and toxic byproducts are formed
Solution Approach 1:
The patent introduces an intermediate barrier layer (such as a coating or liner) between the plastic syringe material and the sterilization-sensitive fluid. This intermediary prevents direct interaction between EtO gas and the fluid, thereby maintaining pH stability and preventing toxic byproduct formation while still allowing sterilization to occur
Solution Approach 2:
The patent modifies the chemical or physical parameters of the syringe material through treatments such as cross-linking, coating, or material selection (e.g., using cyclic olefin polymer). These parameter changes reduce the material's reactivity with EtO gas, preventing pH shifts and toxic byproduct formation during sterilization
2Stability of the object's composition
If glass syringes are used to prevent EtO ingress, then pH stability is maintained, but fragility and cost increase
Solution Approach 1:
The patent creates a composite structure by combining plastic syringe material with protective layers or treatments (such as cross-linked polymer networks or protective coatings). This composite approach maintains the pH stability benefits of glass while retaining the manufacturing advantages and fragility-free characteristics of plastic
Solution Approach 2:
The patent optimizes the plastic syringe design to be a disposable single-use device that provides adequate protection against EtO ingress for the duration needed. This approach eliminates the need for durable, expensive glass syringes while maintaining safety and efficacy for the intended use lifecycle
3Stability of the object's composition
If separate packaging or additional sterilization processes are used for plastic syringes, then pH stability is maintained, but efficiency decreases and costs increase
Solution Approach 1:
The patent combines the syringe and its protective barrier into a single integrated component that can be sterilized together with the fluid in one EtO sterilization cycle. This merging eliminates the need for separate packaging or additional sterilization steps, thereby maintaining pH stability while improving manufacturing efficiency and reducing costs
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 solution effectively maintains the pH of sterilization-sensitive solutions within the required range, reduces toxic byproduct formation, and allows for simultaneous sterilization of the syringe assembly with other kit components, enhancing efficiency and reducing costs compared to glass or separate packaging methods.
Implementation Method 1
A syringe assembly made from cyclic olefin polymer (COP) or cyclic olefin copolymer (COC) with a high gas impermeability barrier prevents EtO ingress
Data Source
AI summary
A method of sterilizing a prefilled syringe comprises assembling a syringe assembly and performing at least one ethylene oxide (EtO) sterilization procedure cycle. The assembling step includes inserting a tip cap at a first end of a plunger, filling a non-glass barrel with sterilization sensitive material at a second end of the barrel, and inserting the plunger into the barrel at a second end to seal the sterilization sensitive material within the barrel. The EtO sterilization procedure cycle comprises undergoing a preprocessing stage, a wash and conditioning stage, an EtO sterilization stage and a wash and post exposure stage. Upon completing the EtO sterilization procedure cycle, a resultant pH of the sterilization-sensitive material does not exceed an acceptable pH range as defined by the United States Pharmacopeia. The disclosure also discusses inserting an assembled prefilled syringe into a procedure tray prior to performing the EtO sterilization procedure cycle.