State of knowledge : Isolators in France
Chimie ParisTech; Sorbonne Paris Cité; Chemical, Genetic and Imaging Pharmacology Laboratory, F-75006 Paris, France
CHI Poissy Saint Germain-en-Laye, Pharmacy department, 20 rue Armagis. 78105 Saint Germain-en-Laye, France
In France, special isolator design was developed for anticancer drug preparation in hospital pharmacy in the 90’s. GERPAC estimates the number of isolator users in France around 80% of the facilities used for cytotoxic preparation. Unfortunately, none national survey has been conducted yet to investigate the environmental contamination with cytotoxic using this technology. The reference design of the isolator is the combination of: physical barrier which include “permanent” enclosure, air vented through HEPA filters and 100% of the air removed outside the building (total exhaust), positive air pressure and sterility of the enclosure thanks to a gas sterilization process with either peracetic acid or hydrogen peroxide. Evolution of the design from the beginning of the use of the isolator in France was the introduction of containment systems for exiting end-product and wastes.
One reference work has been published , conducted in two French hospital pharmacies using the same isolator (ISOCONCEPT®) and the same exhaust system of end-product and waste (BIOSAFE ®door). The results showed a very rare and low level of surface contamination of the surroundings of the isolators for 4 cytoxics drugs (Cyclophosphamide, Ifosfamide, 5 Fluorouracil and Methotrexate). The isolator Neoprene® gloves (side in contact with the hands of handlers) were not contaminated. The isolator seems to be a good collective protective equipment able to protect the handlers. The few positive points found to be contaminated with cytotoxic were located on surface used for preparing the cytoxic vials before entry inside isolator. On another hand the inside surfaces of the isolators were contaminated and the contamination would be randomly transferred to the surfaces of end-products. This last data suggests that there is a residual risk of exposure in pharmacy department due to the external contamination of the vials and in wards when the nurses remove the containment overwrapping of the end-product.
To check the impact of the rare cytotoxic surface contamination on handler’s exposure, two new studies were performed in collaboration with Paul JM Sessink, Exposure Control, The Netherlands and Rudolf Schierl, Institute for Occupational and Environmental Medicine, University Munich, Germany. The main results given by these studies are the lack of biological exposure with cyclophosphamide and platinum of the handlers using the isolator described above. The confirmation of the contamination of drug vials which contributes to find some spots of contamination around the isolator and the inconstant but possible risk of contamination when handlers are in contact with the vials outside the isolator. All in all, it is possible to confirm that the isolator gives a high level of protection mainly due to the containment design. But it would be outlined that the surface of end-products can be randomly contaminated which justify the use of containment systems. The isolators without exit containment systems should be investigated for environmental contamination due to the risk of increasing contamination of the surroundings. In anyway, outside the isolator, it should be highly recommended to wear personal protective equipments, especially gloves when handling potentially contaminated material (cytotoxic vials, end-products without containment overwrapping).
 Crauste-Manciet S., Sessink PJM, Ferrari S., Jomier J-Y., Brossard D. Environmental contamination with cytotoxics drugs in healthcare using positive air pressure isolator. Ann Occup Hyg, 2005,49(7) :619-628.