When the subcontracting of cytotoxic drugs is unfeasible, what to do?

1 October 2014

A.Beausir, C.Fournier, B.Frimat Service Pharmacie,
Centre hospitalier de Lens

In order to face with an increase in activity, and to achieve compliance of our unit of chemotherapy, our hospital is about to acquire a new isolator. We had to find a solution to maintain production so that the construction work could be done. To subcontract increase production time, cost and logistical problems, that’s why we preferred to use a temporary Controlled Atmosphere Area (CAA).

A call for tenders for a CAA (overpressure, class D, during 3 months) and an isolator has been launched. The selection criteria were: (1) characteristics of workstation, comfort and quality of work, installation costs and qualification of the new CAA, and (2) characteristics, installation and training costs, and qualification of the isolator.
Only two suppliers answered, Eurobioconcept and JCE biotechnology. Eurobioconcept proposed the “Steriroom-L” system, a transparent tent (dimensions 3.85 m x 4.00 m) with a lock chamber and a cooling system connected to the ventilation module. A serving hatch transfers the finished products. A single workstation isolator, with a second workstation, are provided for free. The bio-decontamination agent is the hydrogen peroxide. This temporary solution costs € 37900 (€ 17000 for the purchase of the tent, the rest for its installation; excluding VAT).

JCE proposed the LSB module, i.e. an “all-inclusive truck” (dimensions 2.34 m x 13.30 m), including the clean room, the connecting zones, and the administrative area. However, due to a lack of space, the isolator consisted of a single workstation. Peracetic acid was used as bio-decontamination agent. The total cost was € 49300 (€ 27800 euros for the truck rental and installation, 17400 euros for the isolator, and 4100 euros for work; excluding VAT).

Depending on the cost of the proposed systems, their comfort, ergonomics and logistics, we have selected the system Steriroom-L. The tent is located in a room of 30 m2; its pressure is +50 Pa, in class C. A system “one-way” has been established in an area of 50 m2 for the circulation of preparations, staff and waste. After one month of activity, and despite some problems to adjust the temperature, this temporary solution is quite satisfactory; we maintain our production in good conditions.

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