Cleanroom Whitepapers and Case Studies

  1. ECI Solves MRO's Chromium Contamination Problem With 900 Series Monitor/Controllers 2/16/2023

    Cr(VI) is a regulated contaminant in drinking water because it can cause gastrointestinal, liver, and developmental toxicity in humans when ingested. A facility was unable to discharge to their POTW because the CR(VI) concentration in their wastewater stream was over the regulated discharge limit. 

  2. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/25/2024

    Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

  3. Centrifuges Transforming Biopharmaceutical Development And Manufacturing 5/23/2023

    Single-use centrifuges have the potential to become the new bioprocessing standard, helping manufacturers meet the need for innovative production methods when facing emerging modalities and next-generation biotherapeutics at scale.

  4. 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.

  5. Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing 5/7/2024

    For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

  6. FDA Recommendations For Gene Therapy For PMDs 3/18/2024

    Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

  7. The Role Of Hexapods In High-Precision Machining 10/1/2024

    A custom hexapod was introduced at ILA Berlin 2024, enhancing precision in aircraft construction. This 6-DOF system improves contour machining of CFRP components, reducing manufacturing times and costs.

  8. From Open Cleanrooms To Closed Systems – What Is Driving The Change? 3/14/2025

    Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.

  9. Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing 2/11/2025

    Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.

  10. A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks 6/6/2024

    A mobile cleanroom facility was needed for manufacturing a new monoclonal antibody product for phase 1 clinical trials. The facility had to have the ability to be repurposed for additional applications.