Aseptic Packaging for Sterile Ophthalmic Injection Devices
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Solution Overview
Problem
Current methods for sterilizing pre-filled syringes, particularly those for ophthalmic use, face challenges in maintaining sterility and stability due to mechanical and chemical stresses, with terminal sterilization methods like ethylene oxide posing risks to biologic drugs and requiring complex multi-step processes.
Innovation Solution
A method for aseptically packaging sterile injection devices by introducing a sterile injection device body, plunger, and pharmaceutical composition into an aseptic environment, filling, stoppering, and packaging without the need for terminal sterilization, thereby avoiding ethylene oxide and radiation-based methods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If terminal sterilization methods (ethylene oxide, radiation) are used to sterilize pre-filled syringes, then sterility is achieved, but drug degradation and instability occur due to mechanical and chemical stresses
Solution Approach 1:
The syringe is stoppered with a plunger before terminal sterilization, creating a sealed environment that protects the drug from sterilization stresses. The plunger acts as a preliminary protective barrier that prevents direct exposure of the pharmaceutical composition to ethylene oxide gas or radiation, thereby maintaining drug stability while achieving sterility through the packaging system
Solution Approach 2:
The plunger serves as an intermediary element between the sterilization process and the drug substance. By positioning the plunger to seal the syringe barrel, it mediates the sterilization process by allowing the sterilization to proceed on the packaging and external surfaces while blocking direct contact with the sensitive pharmaceutical composition, thus resolving the contradiction between achieving sterility and maintaining drug stability
2Reliability
If terminal sterilization is performed after filling, then sterility is ensured, but complex multi-step processes and multiple locations are required
Solution Approach 1:
The invention merges the filling operation and terminal sterilization into a single integrated process step. The syringe is filled and stoppered in sequence without breaking the sterile barrier, allowing both operations to be performed in one continuous workflow within a single manufacturing location, thereby simplifying the overall process while ensuring sterility
3Reliability
If pressure changes occur during sterilization, then sterilization is effective, but syringe parts move unpredictably compromising sealing and sterility
Solution Approach 1:
The plunger is positioned and secured in the syringe barrel before sterilization to act as a cushioning element that absorbs and compensates for pressure changes during the sterilization process. This preliminary positioning ensures that even when pressure fluctuations occur, the plunger maintains contact with the barrel walls and preserves the seal, preventing compromise of sterility
Data Source
AI summary
The present disclosure provides novel processes for providing sterile, pre-filled syringes or injection devices for pharmaceutical compositions, including protein and biopharmaceutical formulations. In some examples, secondary packaging is performed in an aseptic environment, which removes the need for any terminal sterilization method. In some examples, the aseptic packaging method results in a sterile injection device suitable for use in ophthalmic injections.