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

You may also like

Regulatory

Sterility testing | USP 795 & 797 revisions

Read more
In this episode, the discussion is about the sterility test requirements

Trending Articles

  1. BSI launches world’s first global standard to measure environmental impact of producing medicines The British Standards Institution has released the first-ever framework for how to measure and assess the environmental impact of pharmaceutical products
  2. 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
  3. You need to be a subscriber to read this article.
    Click here to find out more.
    Annex 1 and “first air”: What is it and how is it used? First Air as a concept is a major update in the new Annex 1 to continue global harmonisation of regulatory standards, but what is it and how is it used in the new document to improve clarity and compliance? Josh Russell, VP of Sales and Marketing at AST discusses
  4. Cleanrooms: What is the difference between clean-up period and recovery time? The implementation of the new Annex 1, and references to the ISO 14644 family of cleanroom standards have raised questions around the "Recovery time" and the "Clean-up period." Nataša Štirn from Klimer and ICCCS Chair Conor Murray discuss
  5. You need to be a subscriber to read this article.
    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

Relevant companies

See more

Upcoming event

CPhI Middle East

8–10 December 2024 | Conference | Riyadh, Saudi Arabia See all

You may also like

Regulatory

Sterility testing | USP 795 & 797 revisions

In this episode, the discussion is about the sterility test requirements
Hi Tech Manufacturing

FDA recalls ByHeart Infant Formula amid infant botulism outbreak

The US Food and Drug Administration (FDA) has begun investigations into manufacturing controls and cleanroom practices after infant botulism outbreak
Sustainability

BSI launches world’s first global standard to measure environmental impact of producing medicines

The British Standards Institution has released the first-ever framework for how to measure and assess the environmental impact of pharmaceutical products
Hi Tech Manufacturing

Connect 2 Cleanrooms and Cleanroomshop offer £100 off Particles Plus counters this Black Friday

Discounts across the full Particles Plus range support continuous cleanroom air quality monitoring
Regulatory

Cormica recognised as the Top Microbiological Testing Service in the UK 2025

This achievement reflects the strength and continued growth of Cormica’s integrated microbiological testing offering, centred at its UK laboratory Wickham Micro, based in Gosport, UK
HVAC

Samsung Electronics acquires Europe’s largest HVAC company

Samsung Electronics has completed the acquisition of FläktGroup to strengthen global position in heating, ventilation and air conditioning markets
Regulatory

ABN Cleanroom Technology launches rental solution for production of cytostatics for Belgian hospitals

Amidst new pharmaceutical inspection regulations, ABN Cleanroom Technology has launched a turnkey rental solution of cytostatics for Belgian hospitals called CYTONIX
Subscribe now