Process with Precision: Elevating quality and compliance in giving set manufacturing

PROCESS WITH PRECISION: ELEVATING QUALITY AND COMPLIANCE IN GIVING SET MANUFACTURING

Author(s):

Abbott

Publish Date:

April 2024 | 5 minutes

Abstract:

Giving sets, such as Abbott FreeGo and Gravity sets, play a crucial role in healthcare, enabling the safe and accurate delivery of enteral nutrition. The manufacturing process of these giving sets is a highly automated and intricate endeavour. This article outlines the meticulous manufacturing process, with emphasis on patient safety and product effectiveness.

Download PDF (pdf 4 MB)

The Manufacturing Process Quality and Regulatory Assurance Monitoring Performance for Continuous Improvement

Giving sets, such as Abbott FreeGo and Gravity sets, play a crucial role in healthcare, enabling the safe and accurate delivery of enteral nutrition. The manufacturing process of these giving sets is a highly automated and intricate endeavour, combining advanced technology and stringent quality control measures.

Our products are proudly manufactured at our state-of-the-art facility in Sligo, Ireland, where we have honed our craft in medical device manufacturing for five decades. Throughout this journey, we've evolved and adapted our manufacturing processes to thrive in the precise world of medical device production. Our success is attributed to a strong foundation of knowledge and talent management, placing a paramount focus on engineering precision and cutting-edge automation.

In this article, we will shed light on the meticulous process involved in the manufacturing of Abbott giving sets, emphasising the significance of this process and the materials used to ensure patient safety and product effectiveness.

The Manufacturing Process

Sourcing High-Quality Materials 

The foundation of a robust giving set lies in selecting high-quality raw materials with stringent specifications. These materials are typically plastic compounds used to mould the various components of the set, such as rigid plastic pieces and flexible tubing. Abbott prioritises patient safety by ensuring that all materials meet international quality standards.

Moulding and Extrusion

The moulding and extrusion departments are responsible for creating the essential elements and shaping and forming them to create the components that make up the giving sets. The moulding and extrusion department produces nine parts that make up the FreeGo and Gravity sets.

Product Assembly

Once the components are ready, they move to the assembly line, where automation takes centre stage. A series of robots on a linear indexing machine assembles the components with minimal manual intervention. This ensures precision and consistency in the assembly process.

Packaging 

To maintain the integrity and sterility of the giving sets, they are automatically packed in flow wrap packages. The packaging specifications are designed to create a sterile barrier, safeguarding the sets from contamination.

Sterilisation

After packaging, the sets are transported to a sterilisation facility. The primary and secondary packaging plays a crucial role in allowing gas to penetrate and sterilise the products while removing any residual material. This ensures that the giving sets remain sterile.

Quality Testing

The quality team conducts in-process and final quality testing, taking a specified number of sets regularly. These tests help maintain the high standards required to ensure patient safety.

Quality and Regulatory Assurance

Abbott operates under stringent quality standards, complying with the Medical Device Regulation (MDR) and ISO 13485. Regular audits by notified bodies and quality system assessments ensure compliance with industry regulations.

Monitoring Performance for Continuous Improvement

Short Interval Control (SIC) monitors the manufacturing process's real-time performance. Data is reviewed at appropriate intervals, allowing for immediate action if any aspect of production drifts from the expected standards. This proactive approach not only ensures that all giving sets are compliant and that we continuously improve the quality of our products, but also facilitates efficient alignment with demand.

Articles

Abbott Services

UK-N/A-2300474 | April 2024

Adult