Facility design and construction requirements | USP 795 & 797 revisions

Published: 22-Oct-2025 Featured companies: Eagle Analytical
Regulatory

Join Eagle Analytical for the latest installment of its ongoing series on USP 795 and 797 revisions, where it will delve into the topic of facility design and construction requirements

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Sterility testing | USP 795 & 797 revisions

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  1. FDA warning letter flags serious violations at New Jersey manufacturing facility for GLP-1 weight loss jabs The US Food and Drug Administration has issued a warning letter of deficient cleanroom design, contamination controls and quality oversight in sterile GLP-1 drug production at a New Life Pharma facility
  2. Cleanroom Technology Awards 2026: The winners The winners of the Cleanroom Technology Awards 2026 have now been revealed. The 2026 edition brought together some of the most forward-thinking organisations in the industry, recognising innovation, technical excellence, and impactful advancements across cleanroom design, operation, and technology
  3. GMP Annex 1: Validation of disinfectants on cleanroom surfaces Published in August 2022, for implementation in August 2023, Karen Rossington from Contec looks at the revised version of EU GMP Annex 1 expanded and clarified the regulatory requirements of cleaning and disinfection in life science cleanrooms
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    Click here to find out more.
    What is ISO 8 cleanroom classification? Each cleanroom class is denoted by a maximum concentration of particles per cubic meter or cubic foot of air. ISO 8 is the second lowest cleanroom classification
  5. What is EN 17141? EN 17141 Cleanrooms and controlled environments – Biocontamination control is a relatively new European standard, introduced in 2020, that establishes and demonstrates best practices to control airborne and surface microbiological contamination in controlled environments, such as cleanrooms

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Sterility testing | USP 795 & 797 revisions

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