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Rouge and Elastomer Management in Biopharma: Hidden Risks, Smarter Strategies The foundation of biopharmaceutical operations lies in process accuracy, system robustness, and regulatory adherence.Yet two often-overlooked areas underappreciated in their operational impact – Rouge formation in stainless steel systems and elastomer asset management—can silently threaten process integrity and regulatory readiness. The good news? With the

In the world of Advanced Therapy Medicinal Products (ATMPs), ensuring sterility is not just a regulatory requirement—it’s a fundamental necessity for patient safety. The complex nature of ATMP manufacturing, with its reliance on living cells and manual interventions, presents unique challenges that demand rigorous sterility assurance practices.  In a recent webinar hosted by Thermo Scientific,

Shanshan Liu, Technical Director at No deviation Pte. Ltd. and an International Board Member of ISPE, will be sharing her expertise at the QSMI Biennial Scientific Conference 2024 & 4th Asian Rabies Advisory Group of Experts (ARAGE) Meeting held at Samyan, Bangkok; Thailand. The presentation, “New Modalities & Emerging Technologies,” explores the rapidly evolving landscape

As regulatory standards evolve, the implementation of select technologies becomes vital to meet the requirements of cleanroom environments. In the latest update to the EU GMP Annex 1 in 2022, isolators have emerged as the preferred technology in aseptic fill finish processes to ensure ideal cleanroom conditions and minimize microbial contamination associated with human interventions.