Featured Articles

  1. Evaluate CCI Of Vial And Syringe Systems Over Time And Temperature

    Combining techniques, such as Residual Seal Force, tracer gas analysis, and headspace analysis, enables a more complete and quantified measure of CCI for vial and syringe combinations.

  2. Parenteral Packaging And Delivery Systems: Container Closure Integrity

    Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.

  3. Trends In Combination Products

    As demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug/device combination products.

  4. The Role Of The Contract Manufacturer In Medical Device Development

    With a trusted contract manufacturing partner, pharma companies can ensure that their innovative therapies come to market efficiently without compromising the quality of the drug and its delivery system.

  5. Is It Ever Too Soon To Start Your Performance Testing Assessment?

    Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

  6. Key Considerations For Selecting Fill/Finish Manufacturing Technologies

    Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.

  7. Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems

    Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.

  8. Mitigating Particulate Risk In Injectables

    What are the sources of such particulates in injectables, and how should manufacturers apply the latest regulations to ensure best practice when producing sterile drug products?

  9. Container Closure Integrity Evaluation For Cell And Gene Therapies

    With the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.

  10. Prefillable Syringe Plungers: A Solution For Low Temperature Storage

    Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.