Microbiological controls of aseptic handling in Dutch hospital pharmacies: Results, limits, and methods for assessing.

Introduction: 'Aseptic handling is the procedure to enable sterile products to be made ready to administer using closed systems' (EU Resolution CM/Res(2016)2). Microbiological controls are an important part of the overall assurance of process and product quality of aseptic handling. They consist of the End-of-Session Broth Test (ESBT) using Tryptone Soya Broth, Microbiological Monitoring (MM) using Ø 55- and 90-mm agar plates and a periodical Operator Broth Transfer Validation Test (OBTVT) using Tryptone Soya Broth.