Development of an organisational model for the preparation of the mRNA-bnt162B2 vaccine: the experience of the Clinical Galenics Laboratory of the Hospital Pharmacy of the Mauriziano Hospital, Turin

Abstract

The centralised preparation of the mRNA-bnt162B2 vaccine at the Clinical Galenics Laboratory of
the Hospital Pharmacy of the Mauriziano Hospital in Turin is an organisational model designed to guarantee the quality of the drug to be administered, the safety of both the vaccinee and the vaccinating personnel, and
the traceability of all operations performed. The preparation in ready-for-use syringes individually packaged
and labelled, according to the Good Manufacturing Practice (GMP) of the Official Pharmacopoeia, was entrusted to the Biomedical Laboratory Technician (BLT) under the responsibility of the Hospital Pharmacist.
In compliance with the GMP, the model was developed through dedicated premises, specific staff training
and written procedures concerning the handling of vaccines. The entire production process was guaranteed by:
a Hospital Pharmacist and two interchangeable BLTs, one preparer and one assistant. They were necessary
to maintain the aseptic technique and the cross-checking of all operations. Labels were prepared showing qualitative-quantitative composition, batch and expiry date, validity of the preparation, pharmacist’s signature. The
label applied to each syringe, together with the daily work plan, ensured traceability of the process at every stage.
The efficient model proposed has always proved adaptable to the changes that characterised the vaccination campaign. From 27/12/2020 to 31/03/2022 a total of 48.017 doses were prepared. The centralisation of the vaccine preparation in the Clinical Galenics Laboratory of the Hospital Pharmacy also reduced handling errors, as well as the waste from unused residues, which proved to be only 0.08%.