Regulatory

  1. Micro Leak Detection Of Syringes, Vials And Liquid Filled Packaging With The VeriPac 455 11/16/2021

    VeriPac 455 is a non-destructive inspection system for highly sensitive micro leak detection of empty & pre-filled syringes, liquid filled & lyophilized vials and other liquid filled packaging. The VeriPac 455 inspection technology that can be incorporated into protocols at any point in the handling process as it is non-destructive, non-invasive and requires no sample preparation. 

  2. Annex 1 FAQs: Responding To The 2022 Revision 5/11/2026

    Viewing the Annex 1 revision as a natural extension of current habits, rather than a burden, allowed for a seamless transition. Since contamination control was already standard, the update simply validated existing excellence.

  3. Simplifying Bioprocess Data Collection 2/17/2023

    Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.

  4. A Data-Driven Approach To Container Closure Integrity

    Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.

  5. Navigating Regulatory Shifts: EU GMP Annex 1 And USP 382 5/20/2025

    Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.

  6. Quality Time With Oliver: Guest - Dave Exline 10/5/2026

    Particulate analysis and Container Closure Integrity Testing determine whether a pharmaceutical batch holds up under regulatory scrutiny, and why a single flawed reading can carry real consequences.

  7. Strategies For Startups — How To Structure Milestones For Successful Outcomes 5/3/2021

    Experts from the cell and gene therapy field share their experiences and discuss trends to accelerate therapies from the bench to the bedside, with specific focus on strategies for start-ups, how to look at robust scale-up, and reducing CMC risk.

  8. Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging

    Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

  9. Start Packaging Development Early 5/12/2026

    To avoid costly delays later in the product lifecycle, it is essential to plan for key variables early and select container closure systems with confidence from the outset.

  10. Annex 1 FAQs: How Is Behavior Changing As A Result Of EU GMP Annex 1? 5/11/2026

    EU GMP Annex 1 is driving meaningful changes in how teams behave inside cleanrooms. Understand what contamination awareness really means in practice and how to build a culture where speaking up is standard.