Industry Insights

  1. New Guidelines Offer Menu Of Standard Sterile Packaging Tests

    High-risk packaging applications, such as pharmaceutical and class III medical devices, are coming under increasing scrutiny. A package protects the product throughout the product life cycle, and package integrity is a significant pocket of risk that can be mitigated. 

  2. Paving The Road To Compliance: Serialization Standardization Through Open-SCS

    As companies around the world implement the necessary changes to become compliant, it will add an increased level of cost, risk, and especially complexity to today’s operations. Specifically, part of these mandates requires that production floor and warehouse equipment are able to exchange information with a customers’ business system throughout the drug’s packaging lifecycle.

  3. The Multivariate World Is Expanding For Research And Industrial Data Analysis

    The field of chemometrics has been around for quite some time now and has played its role in both research and industrial environments. While the multivariate research toolbox is well established and ever increasing, its industrial counterpart is only beginning to see widespread use in the last decade.

  4. How Big Data Is Transforming Pharmaceutical Manufacturing

    Pharmaceutical manufacturers now have the ability to analyze massive amounts of quality, environmental, and IoT-generated factory data, which enables them to build end-to-end process controls — resulting in higher-quality products, more predictability, more efficient manufacturing, and faster time to market.

  5. Chambers Versus Room Monitoring: What Sensors Are Best For Your Application?

    Many chamber applications are cold temperature applications and usually temperature is the only parameter monitored. Cold air cannot hold much moisture so it is uncommon to use a humidity sensor in a cold temperature situation (specifically closed chamber situations wherein the air is cycled over the cooler to remove the condensation. But initial cooling will result in 100% RH. But for the purposes of continuous monitoring we can go with the lower RH accompanying colder temperatures). Low temperature presumes low humidity.

  6. Blow/Fill/Seal Technology Automates Aseptic Vaccine Packaging

    Today, the trend with vaccine packaging is ready-to-administer single-dose packaging. Whether in the form of prefilled syringes or single-dose twist-off containers, this type of packaging offers safety, convenience, and cost benefits over traditional multidose vials.

  7. Automatic Lubrication Systems Enhance Performance And Cut Costs In Pharmaceutical Manufacturing

    The latest in automated lubrication systems ensure optimum equipment performance — even in demanding pharmaceutical manufacturing environments — and reduce unscheduled maintenance.

  8. Moist-heat Sterilization of Blood Bags

    The complexity of Blood Bags (BBs) and the critical nature of their use inevitably lead to the choice of moist-heat as sterilization method.

  9. Orphan Drugs – Small Batches That Demand Attention

    Orphan drugs, or the drugs made in small batches for immediate medical attention, have the ability to be both life changing and lifesaving for patients suffering from a rare disease.

  10. Pharma Temperature-Sensitive Monitoring With 21 CFR Part 11 Systems

    This app note is intended to clarify how Onset’s InTemp monitoring solutions and technology are compatible within an environment where 21 CFR Part 11 is being employed.