Multicenter Study on Incubation Conditions for Environmental Monitoring and Aseptic Process Simulation.

Unlabelled: Environmental monitoring and aseptic process simulations represent an integral part of the microbiological quality control system of sterile pharmaceutical products manufacturing operations. However, guidance documents and manufacturers practices differ regarding recommendations for incubation time and incubation temperature, and, consequently, the environmental monitoring and aseptic process simulation incubation strategy should be supported by validation data. To avoid any bias coming from in vitro studies or from single-site manufacturing in situ studies, we performed a collaborative study at four manufacturing sites with four samples at each location.

Yeast identification in the clinical microbiology laboratory: phenotypical methods.

Emerging yeast pathogens are favoured by increasing numbers of immunocompromised patients and by certain current medical practices. These yeasts differ in their antifungal drug susceptibilities, and rapid species identification is imperative. A large variety of methods have been developed with the aim of facilitating rapid, accurate yeast identification.

Evaluation of six commercial systems for identification of medically important yeasts.

Six commercially available systems for the identification of yeasts were evaluated using 133 clinical isolates and four reference strains that had been previously identified by conventional methods and 19 recent clinical isolates that had been identified by the ID32C system (bioMérieux, France). The total identification rates (TIR) established for the total number of strains tested and the database identification rates (DBIR) established for the strains included in the respective manufacturer databases were both determined. After incubation for 4 h, the TIR and DBIR were 78% and 84%, respectively, for the RapID Yeast Plus system (Innovative Diagnostic Systems, USA).

Survey of primary drug resistance of Mycobacterium tuberculosis in Casablanca, Morocco.

Setting: In 1990, a 6-month short-course regimen (2 SHRZ/4 RH) was introduced for the treatment of tuberculosis in Morocco.

Objective: To assess the efficacy of the national tuberculosis control programme, a prospective study of primary drug resistance was conducted from April 1992 to July 1994 in Casablanca.

Design: A total of 402 strains isolated from 402 patients living in Casablanca with no previous history of tuberculosis was included in the study.