Emergency opening of sterile preparations unit during COVID-19 pandemic

5 October 2022

E. Gasperi, F. Bordet, M-L. Maestroni
Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France

During 3rd wave of the COVID-19 pandemic, our Intensive Care Units’ (ICU) organization was shaken. Due to work overload and shortages of curare (causing changes of dosage and/or concentration), these units turned to the Pharmacy unit to prepare their curare syringes until the epidemic peak passed.
Our Pharmacy unit has a cytotoxic preparation unit and an unused Controlled Atmosphere Area (CAA) meant for total parenteral nutrition preparation under a laminar air flow ceiling. To avoid any cytotoxic contamination risk, we decided to prepare curare syringes into the unused CAA. However, it was not in conformity with French regulation and cleaned only once a week.

To face this urgent request, we gathered a crisis committee to decide if we could use the laminar flow ceiling, to arrange its daily biocleaning of the CAA, find a suitable equipment for sterile preparations, evaluate ICU’s needs and its feasibility, and to organize this emergency unit organization by mobilizing pharmacists and technicians for preparation and control.
Within 2 days, one of our pharmacist found the furniture and materials necessary to manage sterile preparations under laminar flow ceiling, redacted the unit’s procedures (dressing, preparation and control protocols among others), trained technicians to manipulate under laminar flow ceiling, organized the logistics (flows of raw material, documents, preparations and waste).
To warrant the microbiological quality of the preparations, systemic samples were realized: 2 contact plates on gloves used by the manipulator and 1 settle plate (Tryptic Soy Agar) for each batch prepared.

The technical unit checked the laminar flow ceiling performance and modified pressures in the different rooms of the CAA, so we could start the production the following day. We mobilized a technician from another site to complete the production team.
We choose to produce only one type of preparation, Atracurium 500 mg/50 mL syringes, to maximize productivity rather than producing several preparations in lower quantity.
Production started on March 30th 2021 and lasted until May 14th 2021, 6 days a week when needed for a total of 33 days of production.
2,126 syringes were produced, resulting in an average of 64 syringes a day (min 9 - max 126).
On 160 contact plates and 60 settle plates, none were positive (daily readings check for 14 days).

The emergency opening of this unit was a real challenge, but it provided relief to ICU staff so they could withstand the 3rd epidemic peak. It demonstrated the commitment and quality of pharmaceutical staff during the COVID-19 pandemic.

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