Biological Safety Cabinets - Laminar Air flow: Data from Germany
Munich University, Munich, Germany
(Director Prof. D. Nowak, M.D.)
In Germany, preparation of anticancer drug admixtures is mainly done in biological safety cabinets (BSCs) with laminar air flow. Although no statistical data are available there are estimations that 80 – 90 % of pharmacies are using BSCs. Isolators are installed in a few pharmacies only. Up to now, most of the cytostatic drug preparations were done in hospital pharmacies. However, because there is a trend towards drug administration in outpatient facilities cytostatic drug preparation in retail pharmacies is a growing market.
In any case, safety precautions for cytostatic drugs are an urgent need in order to ensure a safe product for patients and a low risk handling for pharmacy personnel as well. In the year 2000 we established a wipe sampling procedure for environmental monitoring of four relevant drugs: cyclophosphamide (CP), ifosfamide (IF), fluorouracil (FU) and platinum (PT as marker for cis-, carbo- and oxaliplatin). Meanwhile we analyzed more than 3000 wipe samples from various locations. From this data set we present here the statistics of 1147 FU and 953 PT samples from 103 pharmacies (62 % hospital, 38 % retail). The median values for PT varied between 0.2 pg/cm² (offices) and 1.2 pg/cm² (BSCs). For FU, which is handled in higher amounts we found medians from 3.8 pg/cm² (offices) to 10.0 pg/cm² (BSCs and storage areas). Contaminated vials delivered from pharmacy companies are still a very significant source of contamination in the pharmacies. Therefore, wearing gloves is highly recommended also for those staff just opening the delivered cytostatic drug vials.
The most important finding is the fact that contamination is in most cases independent of the handled drug amount. This offers the opportunity to handle cytostatic drugs in a high-quality and safe way. Currently, many pharmacies in Germany accepted to use wipe samples as a helpful tool to improve their handling procedures.