Regulatory

31. The Container Closure Integrity Requirements In The Revised EU Annex 1

    Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.

32. Package Integrity Testing Of Dry-Fill Flexible Packaging With VeriPac FLEX 11/16/2021

    The VeriPac FLEX Systems are available in several configurations to accommodate various package specifications. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics.

33. Navigating Regulatory Expectations For Injectable Packaging 12/4/2025

    Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.

34. Establishing A Container Closure System 5/13/2026

    As a trusted partner to both established and emerging drug developers, we support the safe, effective containment and delivery of life-saving and life-enhancing medicines.

35. EU Med Device Regulations: Ensuring Compliance For Integral Combination Products

    Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.

36. Clinical Strategy For Successful Cell And Gene Therapy — How Did I Get Here? 5/3/2021

    There are major challenges to the widespread adoption of cell therapies, primarily related to the high manufacturing costs of what is largely a manual process with complex logistics and supply chain. Experts share their experiences and discuss emerging trends in the field to accelerate life-saving therapies from the bench to the bedside.

37. Seal-Sensor Technology For In-Line Pouch Seal Inspection 11/16/2021

    PTI is integrating the latest technologies for inspecting pouch seals utilizing a method that inspects and analyzes pouch seals non-destructively. Seal-Scan and Seal-Sensor utilize Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructively.

38. How RTU Solutions Can Meet GMP Annex 1 Requirements 5/14/2025

    EU GMP Annex 1 urges better contamination control. RTU containers help pharma firms reduce risks, cut costs, and streamline aseptic manufacturing with simplified, compliant solutions.

39. VeriPac 465 Micro Leak Test System For Parenteral Products And Rigid Containers 11/16/2021

    The VeriPac 465 is a deterministic micro leak test system for container closure integrity testing combines technological innovation and practical adjustments to patented dual vacuum transducer technology, PERMA-VAC, to make it the most sensitive and versatile vacuum-based leak detection technology to date.

40. 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.