Validation of a manufacturing process within a temporary controlled atmosphere area

4 October 2023

G. Lafci, A. Villain, E. Poutrain, M. Abele, I. Sakji, G. Marliot
Centre Oscar Lambret, Lille, France

Introduction - Objective
Chemotherapy (CT) production had to be interrupted in our controlled atmosphere area (ZAC) to install a CT preparation robot (Apoteca® -Loccioni). A production alternative had to be observed during the 2-week construction period. Given the activity level (42,000 CT preparations manufactured annually), outsourcing was not an option.
The decision was therefore made to acquire a temporary ZAC (Stériroom-L-Eurobioconcept) with positive pressure (class C). Two laminar flow production isolators (Eurobioconcept) in negative pressure (class A) equipped with a ventilated material airlock (MAL) were planned.

This work aimed to validate this new CT preparation process and train staff in this new handling method in line with good preparation practice.

Materials and methods
Medical devices (MDs) and raw materials (RMs) were transferred via the MAL of the Stériroom-L after manual decontamination. Media Fill Tests (MFTs) based on the 2011 PIC/S PI 007-6 recommendations were carried out to validate control of the aseptic process.
To integrate these MFTs into our dematerialized preparation process, the protocols were computerized in the Chimio® software.
To be as close as possible to real-life conditions, four types of preparation were carried out per operator (empty bag, pre-filled bag, syringe, infusor). The KLERKIT kit (Shield Medicare®) was used for manipulations, and the EZ-ACCUSHOT kit (Microbiologics®) for fertility tests.
In addition to handling within the isolator, each operator was responsible for manual decontamination of MDs and RMs required for the MFT, preparation and sterilization of the baskets, and dispatch into the MAL. A pharmacist supervised each operation.

Eleven operators carried out a MFT (10 preparers and one pharmacist), corresponding to 44 preparations. No deviations were observed in any of the manufacturing steps. All fertility tests were positive. No microbiological contamination of the MFTs was observed. They were, therefore, all validated.

Discussion - Conclusion
The aseptic preparation process and the accreditation of 11 operators were validated by the MFTs. No production failures using this new process were observed during the two weeks of work. This preparation method enabled us to continue our production and, thus, patient care.

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