Use of Isolation Technologies for Sterility Testing of Medicinal Products

• DOI: 10.1007/s11094-020-02145-7
• Publication Date: 2020-03-07T08:03:02Z
• Authors: O. V. Gunar; L. V. Tsyganova; A. V. Dorenskaya; N. A. Borisova
• Keywords: Isolator; Isolation; Cleanroom

The importance of using isolation technologies, e.g., an isolator, for sterility testing of medicines is demonstrated. The advantages and disadvantages for the Sterility parameter of using isolators in manufacturing processes and pharmaceutical analysis during examination and quality control stages are discussed. The goal of the work was to optimize the chamber biological cleaning mode with a working load in a GPPI isolator (ESCO, Indonesia), which enables this equipment to be used for sterility testing of medicines. The parameters on which the success of the biodecontamination cycle of the isolator chamber depends are analyzed. Potential biological cleaning modes are studied. The optimum mode for the working load using the GPPI isolator as an example is found. The isolator system is proven to provide sterile working conditions corresponding to cleanroom class A, which makes the equipment suitable for sterility testing of medicines.