Critical Environments Columns

  1. Expert Voices: Why Aren't QC Labs Fully Automated Yet? 10/4/2024

    Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.

  2. The Influence Of Flows In cGMP Architectural Design 8/22/2024

    In drug manufacturing facility layout, balancing the roles of layout and procedure plays a critical role. This article examines how the interplay may be resolved, and how this resolution affects facility layout during design.

  3. Are You Taking The HPCs In Your ADCs Seriously? 8/16/2024

    The wave of ADC (antibody-drug conjugate) development and manufacturing activity we’re currently witnessing, and importantly, the HPC (high-potency compounds) comprising the payloads in these therapies, demand thorough assessment of development and manufacturing facility design.

  4. This Takeda Official Thinks Pharma 4.0 Won't Be Optional Much Longer 8/14/2024

    Advanced technology like automation was once seen only as a competitive advantage. That viewpoint is shifting amid greater reliance on digital technology.

  5. 2024 Emerging Trends In Cleanroom Technologies 8/14/2024

    This article shares new market research on pharma/biotech cleanroom technologies, including regional trends, prominent vendors in the space, and more.

  6. BPSA's Single-Use Summit Celebrates Its "Stainless" Anniversary 7/29/2024

    The Bio Process Systems Alliance (BPSA) is devoted to the advance of single-use technologies in biopharmaceutical manufacturing. At its 11th International Single-Use Summit, the explosive growth in single-use was on full display, and the sourcing, safety, sustainability, and application discussions on the agenda were comprehensive.

  7. How Eli Lilly's Making Peptides Faster And More Reliably 7/17/2024

    Three company leaders answer questions about the IE2b project, which is receiving an ISPE 2024 Facility of the Year Award for its ingenuity of complexity.

  8. Chugai's Race To Zero Emissions At UK4 In Tokyo 6/21/2024

    Chugai's sustainable model led the construction of a new DS/DP manufacturing site, UK4, in Tokyo. The company focused on eliminating three key emissions sources.

  9. Design And Function Of GMP Transition Spaces 6/12/2024

    In pharma/biotech GMP, there are several spaces that function as transition spaces, such as air locks. This deep dive discusses how procedure and arrangement can influence their effectiveness.

  10. Are Annex 1's CCS Requirements Still Challenging You? 6/5/2024

    Contamination control strategies are nothing new, but their inclusion in the Annex 1 update represents one of the revision's few new requirements.