Critical Environments Columns

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. GMP Plant Uniform Lockers And Procedures: Best Practices 4/22/2024

    As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.

38. Single Use In Biopharma: Beyond Savings & Sustainability 4/17/2024

    SUT continues to trend in biopharmaceutical applications, driven largely by environmental and economic considerations. But there’s a lot more to the SUT story, including supply chain and standardization advantages. We dove headlong into those issues and more with independent SUT expert Paul Priebe and Krystal Biotech VP of Technical Operations Mark Petrich.

39. Designing Highly Agile Bio/Pharma Manufacturing Facilities 4/5/2024

    In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules. 

40. A Quality-Led Approach To Drug Production Facility Design 3/26/2024

    There are important considerations that architects and engineers can miss if they don't include the quality perspective. It's better to involve quality at the outset rather than discover omissions when it's too late.