MICROBIO: a web-based program for processing and evaluation of microbiological controls on aseptic dispensing

Background According to the Dutch GMP-hospital pharmacy directive (1) three types of microbiological controls are required when aseptic dispensing is performed: 1. microbiological monitoring of the air in the working area, the gloved hands of the operator and the work surface at the critical place in the laminar airflow cabinet; 2. microbiological validation of the operators through media fill runs; 3. validation of the aseptic process by repeating the procedures with an appropriate broth. Purpose To develop a web-based program for data of microbiological controls on aseptic dispensing for Dutch hospital pharmacies for: simple processing of environmental monitoring data; trending of environmental monitoring data; comparing individual data with other hospital pharmacies nationwide. Materials and methods The web-based program MICROBIO was designed in collaboration with an expert group of hospital pharmacists. Participating hospital pharmacies collected microbiological control data and entered them into the program. Limits for microbiological contamination are based on EU-GMP recommendations (2). Results Currently 49 of 80 Dutch hospital pharmacies use MICROBIO. More than 85% of the microbiological controls on monitoring comply with the results (air 87%, gloved hands 90%, work surface 86%). Conclusions MICROBIO is a standardised tool which fully supports processing data and evaluation for all three types of microbiological controls and presents them in diagrams and histograms. The results show that the directive on aseptic dispensing in GMP-hospital pharmacy is met. Literature 1. Aseptic dispensing. In GMP-hospital pharmacy. The Hague: Dutch Association of Hospital Pharmacists; 2005; www.nvza.nl. 2. The rules governing medicinal products in European Union. Volume 4. Good manufacturing practices. Medicinal products for human and veterinary use. Annex I. Manufacture of sterile medicinal products. European Commission, revision May 2003.