Search Results - STERILE PHARMACEUTICALS

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    Microbiological quality of non-sterile pharmaceuticals in Egypt by Nourhan Mahrous Ahmed Salem, Mohamed Abbas Elbarrawy, Nashwa Fawzy Abd El Moez Azzam

    “…Abstract Background The context and purpose of the study are as follows: Drug-borne infections may arise from non-adherence to strict microbiological quality of pharmaceuticals products. Moreover, presence of exceeding levels of microorganisms in non-sterile pharmaceuticals may lead to change of their organoleptic characteristics and loss of effectiveness. …”
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    Culturable microbiological profile of a non-sterile drugs pharmaceutical production environment by Gustavo Soares, Dionísio Pedro Amorim-Neto, Karina Cogo-Müller

    “…Abstract For places where non-sterile drug production occurs, regulatory bodies recommend monitoring of the environmental bioburden. …”
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    A comprehensive technology strategy for microbial identification and contamination investigation in the sterile drug manufacturing facility—a case study by Minghui Song, Minghui Song, Qiongqiong Li, Qiongqiong Li, Chengzhi Liu, Peien Wang, Peien Wang, Feng Qin, Lichun Zhang, Yiling Fan, Yiling Fan, Yiling Fan, Hong Shao, Hong Shao, Guiliang Chen, Guiliang Chen, Meicheng Yang, Meicheng Yang

    Published in Frontiers in Microbiology (2024-02-01)
    “…ObjectiveA comprehensive strategy for microbial identification and contamination investigation during sterile drug manufacturing was innovatively established in this study, mainly based on MALDI-TOF MS for the identification and complemented by sequencing technology on strain typing.MethodsIt was implemented to monitor the bacterial contamination of a sterile drug manufacturing facility, including its bacterial distribution features and patterns. …”
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