Primary Packaging Overfilling With Vacuum-Assisted Stoppering
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Solution Overview
Problem
Primary packaging components, such as syringes, often have nominal volumes that are less than the desired volume of formulated drug substance, leading to issues with viscosity, compatibility with delivery devices, increased costs, and compromised sterility due to air exposure and agitation.
Innovation Solution
A method of overfilling primary packaging components with a formulated drug substance beyond their nominal volume using vacuum-assisted stoppering, ensuring the stopper is positioned correctly to maintain integrity and sterility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the nominal volume of the primary packaging component is increased to match the desired dosage volume, then the viscosity and compatibility issues are avoided, but the cost increases and suitable larger packaging may not be available
Solution Approach 1:
The patent applies parameter changes by modifying the fill volume parameter beyond the traditional nominal volume. Specifically, it fills the 1 mL syringe with 1.15 mL to 1.30 mL of drug substance, changing the volume parameter to achieve desired dosage volumes when larger packaging is unavailable. This resolves the contradiction by enabling use of smaller, more available packaging while delivering adequate drug quantities.
2Quantity of substance
If the nominal volume of the primary packaging component is increased to match the desired dosage volume, then the viscosity and compatibility issues are avoided, but the manufacturing cost increases
Solution Approach 1:
The patent applies partial or excessive action by overfilling the syringe beyond its nominal volume. It fills a 1 mL syringe with 1.15 mL to 1.30 mL of drug substance, providing more than the nominal capacity. This excessive filling action allows use of smaller, less expensive packaging while ensuring sufficient drug substance volume for desired dosages, thereby reducing manufacturing costs associated with larger packaging.
3Reliability
If vacuum is applied to the stopper during positioning, then the stopper is positioned correctly to maintain closure integrity, but the process complexity increases
Solution Approach 1:
The patent applies pneumatics by using vacuum pressure to position the stopper within the syringe. The vacuum force draws the stopper to the correct position, ensuring proper sealing and closure integrity. This pneumatic mechanism provides reliable stopper positioning while maintaining relatively simple process implementation, resolving the contradiction between reliability and complexity.
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
Successfully fills primary packaging components with a desired volume of drug substance while maintaining closure integrity and sterility, avoiding issues related to viscosity and compatibility with delivery devices.
Implementation Method 1
positioning the stopper comprises applying a vacuum to the stopper
Data Source
AI summary
Disclosed herein are methods for overfilling primary packaging components, and drug products prepared according to those methods. The methods may include introducing a volume of a formulated drug substance into a primary packaging component having a nominal volume, where the volume of the formulated drug substance is greater than the nominal volume of the primary packaging component. In some cases, the primary packaging component may be a prefillable syringe.