PVC Packaging System Autoclave Sterilization Transparency
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Solution Overview
Problem
Current packaging systems for oxygen-sensitive pharmaceutical products using PVC-based containers face challenges in maintaining sterility and transparency during autoclave sterilization, as PVC is highly permeable to gases, leading to degradation and opalescence, and existing solutions require complex processes or multiple containers.
Innovation Solution
A packaging system comprising a PVC-based primary container wrapped in a water-absorbing material, such as fibrous cellulosic fibers, within a gas-tight secondary container, which is evacuated and filled with an inert gas to prevent mechanical stress and gas contact, allowing for simple sterilization in a traditional autoclave while maintaining sterility and transparency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If PVC-based primary container is used for packaging, then transparency and flexibility are maintained, but gas permeability increases causing substance degradation
Solution Approach 1:
A water-absorbing intermediate layer is placed between the PVC primary container and the secondary container. This intermediate layer serves as a mediator that absorbs water vapor during sterilization, preventing direct contact between steam and the PVC container, thereby maintaining transparency while the secondary container provides gas barrier protection
Solution Approach 2:
The packaging system uses a composite structure combining PVC material (for transparency and flexibility) with a water-absorbing material layer (for steam protection) and a secondary container material (for gas barrier). This composite approach leverages the advantages of each material while compensating for their individual disadvantages
2Reliability
If traditional autoclave sterilization is applied, then sterility is achieved, but PVC container becomes opalescent and loses transparency
Solution Approach 1:
The water-absorbing intermediate layer is placed around the PVC container before sterilization. During autoclave sterilization, this layer absorbs water vapor preferentially, creating a protective buffer that prevents steam from directly contacting and opacifying the PVC container, thus preserving transparency while achieving sterility
Solution Approach 2:
The water-absorbing material acts as an intermediary between the steam sterilization environment and the PVC container, absorbing excess moisture and preventing the thermal and moisture-induced opalescence that would otherwise occur during autoclave sterilization
3Stability of the object's composition
If gas-tight secondary container is used to prevent degradation, then substance stability is improved, but complexity of packaging system increases
Solution Approach 1:
The water-absorbing intermediate layer serves multiple functions: it protects the PVC container from steam during sterilization, maintains structural integrity during processing, and contributes to the overall barrier system. This multi-functionality reduces the need for additional separate protective components, simplifying the overall packaging system while maintaining substance stability
4Reliability
If overwrap is applied before sterilization to ensure sterility, then outer surface sterility is guaranteed, but PVC container becomes opalescent and transparency is lost
Solution Approach 1:
The water-absorbing intermediate layer serves as a mediator between the PVC container and the sterilization environment, allowing steam penetration for sterilization while absorbing excess moisture that would cause opalescence, thus maintaining both sterility and transparency
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
Ensures the sterility and transparency of the primary container post-sterilization, preventing substance degradation and eliminating the need for complex processes or multiple containers, thus meeting pharmaceutical industry standards.
Implementation Method 1
wrapped in a water-absorbing material, such as fibrous cellulosic fibers
Implementation Method 2
pharmaceutical products containing at least one substance capable of degrade by contact with a gas, in particular oxygen
Data Source
Figure 1
AI summary
The object of the present invention is a packaging system that can be sterilized by autoclaving an aqueous product containing at least one substance that is able to deteriorate, of the type including a closed transparent primary container containing said aqueous product and formed of a plastic material based on poly(vinyl chloride) and a closed secondary container surrounding said primary container without constraint and formed of a material able to protect said substance against its deterioration and substantially steamtight. According to the invention, said system additionally includes a material able to absorb water, preferably fibrous, preferably again based on cellulose fibres, placed between said primary and secondary containers and enveloping said primary container; said packaging being able to be sterilized by autoclave without affecting the transparency properties of the primary container.