Background The drug manufacturing conditions in hospitals have become increasingly demanding and the use of a Controlled Atmosphere Area (CAA) in the preparation unit is now mandatory.
Purpose To make an inventory of fixtures used for European aseptic manufacturing units; to compare the cost of CAA provided by isolators to CAA provided by Biological Safety Cabinets (BSCs) in order to determine the most economical scheme in hospital and to develop a model to estimate CAA design and operating costs.
Materials and methods 43 hospitals were interviewed (21 French and 22 from four other European countries) by email, telephone and visits over 7 months. A form with 390 items was programmed in VBA (Visual Basic for Applications) to assist with replying. Hospitals were compared according to their location and their type of workstation: BSCII, BSCIII or UDF (Unidirectional Flow) (Group B) and Isolator (Group I). Statistics were generated using the Mann-Whitney test and Monte Carlo modelling.
Results 21 hospitals responded (11 French and 10 foreign). All European preparation units were organised similarly except that in France, isolator use seems more common than in the rest of Europe (73% vs 30% respectively; p=0.0502). Each cost item was compared; only 2 were significantly different: the staff training cost/agent and the cost/m2 of microbiological control were significantly higher in Group B than in Group I with 3,404 € and 1,731 €/agent respectively (p=0.0028) and 50.46 € and 2.68 €/m2 respectively (p=0.0017). A synthesis costs program was drafted to calculate an estimate preparation cost. The preparation cost in Group B seemed higher than in Group I (41 € and 30 € respectively in study conditions) although this cost difference disappeared when the annual number of items prepared increased.
Conclusions This pilot study provides data that could be used to optimise resources and save money. A further international study would enable significant results to be obtained.
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