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@article{192762,
        author = {Mr. Shubham Sominath Kakde and Mr. Ritesh Keshav Kadam and Mr. Kaushik Kailash Kamble and Ms. Ashwini sukhdev Pundkar and Dr. Santosh Payghan},
        title = {A Review on Sterility Testing In Pharmaceutical Product},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {9},
        pages = {3294-3299},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=192762},
        abstract = {Sterility testing is a fundamental step used to verify pharmaceutical or biotechnology product is truly free from any living microorganism before it reaches the patient. Products like injectables, cell-based formulations, eye preparations and implantable materials demand absolute microbial safety because even unnoticed contamination can alter therapeutic action or create unexpected health risks. In this review, the emphasis is on understanding why sterility testing is required, how it is scientifically performed, and what practical difficulties arise during the process. The paper explains the working logic behind the major test approaches, highlights the role of controlled environments, and outlines how sensitive biotech products often require modified handling. Instead of focusing only on procedures, this review connects the principles, experimental conditions and regulatory expectations into a single picture. The study also touches upon recent improvements such as faster microbial detection technologies and process-automation trends that aim to reduce human error. By exploring both classical and emerging practices, this review helps in building a clear, conceptual understanding of sterility assurance in pharmaceutical and biotechnology industries.},
        keywords = {Sterility assurance, Contamination control, Sterile products, Aseptic handling, Microbial detection, Biotech formulations, Quality monitoring, Rapid methods, Sterilization.},
        month = {February},
        }