Opening a parenteral compounding facility … A Challenge !

D. Fremont, E. Guerriero, M. Dermu, V. Massot, T. Storme Secteur Pharmacotechnie - Service de Pharmacie - Hôpital Universitaire Mère-Enfant Robert Debré
Assistance Publique - Hôpitaux de Paris - 48 Bld Sérurier Paris 19ème, France

Since almost 30 years, our unity compounds parenteral nutrition admixtures (TPN) for hospitalized patients of our paediatric hospital, hospitalized or on home-TPN and, for 5 years for other hospitals. Our production is roughly 23000 admixtures per year (average volume: 1,4L). 

Repeated demands of upgrade of compounding area were accepted in the year 2015. The IGAS report (issued in France in Jan 2015) concerning the risks related to TPN, convinced our administration.
Moreover, our Institution saw in this project an economic opportunity to minimize the impact of the monopoly of the only industrial manufacturer on this specific market. 

The selected project for the new building has to allow the compounding, the control, the packaging and the distribution of 40000 TPN admixtures per year. 

The tight budget (building work and supervision : 1,2M€, equipments: 500k€) and the available surface forced the design of premises and choices of equipments.

Key ideas of the pharmaceutical team during the design of this project were 

  • doubling of the production capacity, 
  • preservation of the production capacity during maintenances,
  • strengthening of the quality control laboratory (insourcing of the media fill tests),
  • Reactivity, adaptability, autonomy.

Risk analysis highlighted some critical points as the workforce (budget constraint, availability – operators valorization), lack of redundancy on certain equipments of the Quality Control laboratory, digital switch-over, and the supply chain constraints (monopoly of certain suppliers of raw materials, Articles of packaging, materials, storage capacity).

The implemented premises and the organization as well as the critical points identified during our risk analysis will be detailed in the presentation.

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