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- Title
Verification of the Membrane Filtration Method for Determining Sterility of Drugs under Medical Isolator Conditions.
- Authors
Gunar, O. V.; Dorenskaya, A. V.
- Abstract
An approach to verification of a membrane filtration technique for determining the sterility of drugs in a medical isolator is presented. The proposed steps carried out in sequence objectively prove that the sterility test was performed in the working area of the isolator that corresponds to cleanliness class A, ensuring the suitability of the equipment for testing the sterility of medicinal products. In addition, three experimental models of loading the isolator chamber are presented. Studies were performed that prove compliance with all acceptance criteria, namely, i) no growth of microorganisms in seed material was detected during incubation for 14 d; ii) no growth in the negative control, proving sterility of the used growth media within 14 d; and iii) growth of microorganisms in the positive control visually comparable with the culture control was observed within 3 d for bacteria and 5 d for yeasts and molds.
- Subjects
MEMBRANE separation; MICROBIAL growth; FILTERS &; filtration; TESTING equipment; DRUGS; HYGIENE
- Publication
Pharmaceutical Chemistry Journal, 2022, Vol 56, Issue 7, p989
- ISSN
0091-150X
- Publication type
Article
- DOI
10.1007/s11094-022-02738-4