Introduction
In single-use design and implementation, integrity and robustness of the system are critically important in assessing risk, especially where no sterile filtration is possible as part of the processing step. This case study describes the design and implementation of a custom AdvantaPure® molded filling assembly used in final fill.
The primary objective of the customer was to re-design the current filling process to minimize potential assembly leak points and maintain sterility assurance level (SAL 10-6). Additionally, the customer was looking to maximize throughput and repeatedly produce accurate fill volumes. AdvantaPure’s engineering team collaborated with the customer to design and conduct testing of various molded assembly connections.
Solutions Explored
The customer explored several potential solutions to their challenge of implementing a filling assembly that minimized leak points and provided accurate vial fills. One of the solutions tested was a multi-end ported surge bag assembly with barbed tubing junctions, including double wye pump elements. The barbed tubing junctions were connected using cable ties (Figure 1). An alternative solution evaluated was a molded filling assembly designed with a Tri-Clamp® on the outlet from the surge bag and molded pump elements (Figure 2).
Figure 1. Bag Assembly with Barbed Tubing Junctions
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Results
During testing, the multi barb ported surge bag assembly did not sufficiently mitigate risk of leak points at the required operating flow rate and pressure. It was determined that the use of barb fittings with cable ties created areas for entrapment and ingress. The assembly also exhibited a large amount of hold up volume that required additional manipulation by the operator for emptying. The molded assembly, however, maintained fluid path integrity under the specified operating conditions due to the molded junctions for the surge bag outlet and double wye pump elements. Additionally, the sloped design of the surge bag into a singular Tri-Clamp® end port outlet minimized hold up volume, delivered accurate filling and proved to be more operator friendly.
Figure 2. Bag Assembly with Molded Components
Conclusion
AdvantaPure’s engineering team worked in partnership with the customer to design a molded solution that was tailored to their specific needs. Based on testing of various surge bag and tubing connection designs, the AdvantaPure® molded filling assembly proved to be an ideal solution to the process challenges faced by the drug manufacturer. As a result, the custom molded surge bag design was chosen over other options for implementation in production.