White Papers

  1. Label Mix-Up Prevention: Using Vision To Improve The Labeling Process

    This white paper explains how vision inspection systems can help protect consumers and your brand.

  2. Maximize Global Regulatory Collaboration In The Marketing Of Combination Products

    Combination products in the medical device industry now occupy a substantial market segment. This article focuses on the maximization of global regulatory collaboration in the marketing of combination products.

  3. Human Factors Considerations For Combination Products

    For medical devices, the use of human factors and usability engineering (e.g., applying the knowledge of human behavior, abilities, and limitations to the design of a medical device) plays a key role.

  4. Containment: Top Industry Methods And Challenges

    Which methods are most prominent in the pharmaceutical containment industry today and what key challenges are pharmaceutical businesses facing.

  5. Understanding ISPE SMEPAC Guidelines And Considerations In HPAPI Containment Testing

    The global HPAPI market was valued at US$14.4 billion in 2016 and is expected to grow at a CAGR of 10.3 per cent, reaching US$34.8 billion by 2025.

  6. Viscous Products No Match For New Container Closure Integrity Technology

    New product types and packaging configurations, such as highly viscous formulations, pose a threat to traditional leak-testing methods, challenging current practices for container closure integrity testing. 

  7. Sustainability By Design

    Sustainability means a balancing act and the ability to maintain a certain regulatory standard and the approach of in-built sustainability is essential when designing biopharmaceutical facilities.

  8. Engineering For Sterile Product Manufacturing Facilities

    This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.

  9. Container Closure Integrity Testing Of Intravenous Bags

    A non-invasive, non-subjective solution that is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system.

  10. Performance Validation: HPAPI Containment Testing in A Risk-Based Era

    Key considerations linked to containment performance testing, data collection methods and the interpretation of results.