Batch manufacture of OPAT by Technical Services

Chris Goodwin

Betsi Cadwaladr University Health Board

Project Background:

In 2018 Welsh Government published ‘A Healthier Wales: Plan for Health and Social Care’. In this document a holistic approach to healthcare was outlined that proposed new models of partnership between providers and individuals that would enable people to minimise their hospital stay.

One treatment pathway that aligns with this framework is OPAT (Outpatient Parenteral Antimicrobial Therapy). This is a method of treatment that uses elastomeric devices to deliver intravenous antibiotics to patients at home.

This service is increasing in popularity yet there are barriers preventing a wider adoption despite the benefits of this method of treatment.

Project Aims:

The aim of this work is to overcome some of the barriers preventing the wider adoption of OPAT by achieving the following:

Develop a fast manufacturing method for cost effective OPAT devices using semi-automation.
Carry out stability studies to increase the assignable shelf life of the product.

Project Outcomes:

A Stability Indicating High Performance Liquid Chromatography method was developed for the analysis of flucloxacillin and related substances. A semi-automated manufacturing method has been developed to enable manufacture of 8g/ 240 mL flucloxacillin elastomeric devices by Technical Services in BCUHB.

Stability studies were carried out on the manufactured doses. The outcomes of these studies are summarized in the table below:

Project Impact:

This project has developed a production method to produce 8g/ 240 mL flucloxacillin elastomeric devices that can be integrated into the Aseptic Production facilities in Wrexham Maelor Hospital (YMW). By investing 3 hours / week of manufacturing time and implementing the OPAT manufactured by Technical Services the following savings can be realised across a 12-month period (assuming one patient per week is treated):

524 Bed Days
Approx £368,500

“I would, without a doubt recommend the service to those that meet the criteria to receive it. I think the idea of the service is something that should become more mainstream.”

Service User – Patient at YMW