Cleanroom Whitepapers and Case Studies

  1. The State Of Plastics Recycling In BioPharma 8/9/2023

    Recycling plastics from biomanufacturing proves uniquely difficult due to circularity, quality, and infrastructure challenges. Nonetheless, change is underway. Learn how this change is being spearheaded by industry leaders.

  2. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

  3. Reducing Water Loss In Oak Park, IL: A Data-Driven Approach 3/19/2025

    Discover how the Village of Oak Park faced persistent water loss by implementing a systematic leak detection and mitigation approach.

  4. Comprehensive Compressed Air Assessments: The 5-Step Process 10/10/2024

    The objective of this paper is to define the five steps required in a compressed air assessment. We will use a real-world example with system information from a magnetic materials manufacturer to clearly illustrate each step.

  5. Intro To USP <1062> - What It Is And Why You Should Use It 7/20/2023

    Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.

  6. Validation And Qualification Approach In New Annex 1 Revision 2/21/2025

    The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

  7. Still Using Paper Diaries To Capture PRO Data? Read This. 1/8/2024

    Access real-world examples of how electronic patient-reported outcome measures (PROMs) optimize data quality and reliability and improve the statistical power of trial data.

  8. Tablet Manufacturing Technologies For Solid Drug Formulation 4/2/2025

    Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.

  9. Tailored ISO 5 RABs Unit To Protect AST's Patented Filling Machine 6/19/2024

    Uncover how AST's satisfaction with Germfree's solution led to the acquisition of two additional units, showcasing the project's success and Germfree's expertise in tailored cleanroom solutions.

  10. Handling Protocols: Key Considerations In The Highly Potent API Market 5/12/2025

    Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.