Modernising aseptic compounding through the use of new technology: a validation and proof of concept study
Authors: Tyrrell G P 
Published: November 2022

Abstract

Introduction
There is an urgent need to reform care pathways to keep patients, wherever possible, outside of hospital and in turn freeing up capacity and addressing the elective backlog crisis. To address such issues and futureproof its services, the NHS is modernising its approach to care. Within the aseptic space, current transformation plans1 require the provision of large-scale quantities of injectable medicines and the leveraging of new aseptic technologies to enable the large scale roll out of services such as outpatient antimicrobial therapy (OPAT).

Aim
CIVAS@IP5 is Wales' first National Pharmacy Technical Services Unit and has recently invested in state-of-the-art technology, which is transforming its aseptic compounding, making it possible to significantly scale up capacity and facilitate the creation of local OPAT services. The technology in question is the Gri-fill®4 2, a semi-automated system for compounding hazardous and non-hazardous sterile preparations. The aim of this study, which is the first in the UK to use the Gri-fill®4, was to report on the suitability of such technology to facilitate the transformation of compounding services.

Methods
Due to its nature, this pilot study required no ethical approval as no patients were involved nor any patient data collected. Over the course of a number of weeks, validation measurements were carried out on the Gri-fill®4. This included time and motion assessments of the current manual pathway of compounding compared to the semi-automated pathway using the Gri-fill®4.

Results
Results revealed that the preparation of an infusion bag using the Gri-fill®4 was achieved within an average of 2.64 minutes. This represents a substantial 80% time saving when compared to the average manual preparation time of approximately 13 minutes. Furthermore, batch preparation of 46 infusions was completed with 50% fewer critical manipulations (92 critical manipulations for the Gri-fill®4 versus 184 critical manipulations for the manual pathway), reducing the potential for error whilst also requiring fewer verifications by staff. Once scaled, this increase in productivity will have significant real-world benefits for local services which are reliant on responsive aseptic compounding provisions. On top of productivity improvements, the introduction of semi-automated compounding has afforded sustainability improvements; with less plastic consumables required for the production of each batch.

Discussion/Conclusion
It is important to note that our data reports on the impact of only one Gri-fill®4 unit. As such there are obvious scalability benefits to our findings but also limitations in regard to the logistics and practicalities of leveraging large scale semi-automated compounding; both of these issues will be explored. In conclusion, the productivity of aseptic units can be drastically improved through the modernisation of compounding technology. This validation study reports on the extent of this improvement and discusses the implications it will have on the future of OPAT and aseptic services.

References
1. P., C., Transforming NHS pharmacy aseptic services in England: a national report for the Department of Health and Social Care by Lord Carter of Coles. 2020.
2. Grifols. Gri-fill 4 Semi-automatic Compounding Device. 2019. Available from: https://www.grifolsinclusiv.com/documents/90075605/0/inclusiv+Gri-fill+4+Brochure/ae8ce6e8-d2e0-49e0-b76f-8121539db44a