Insights On Liquid Dose Manufacturing

  1. Container Closure Integrity Testing: Risks And Methods

    An overview of integrity tests where a high sensitivity are required to prevent the risks of stability failure of highly moisture sensitive drugs or the risk of biological ingress of sterile parenteral drugs.

  2. Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing

    This application note details FDA released guidance titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."

  3. Using Positive Controls In Container Closure Integrity Studies

    This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.

  4. Selecting The Best Pharmaceutical Mixing Equipment For Your Operations

    Finding the right mixing equipment isn’t as simple as selecting an item from a menu. This article is a guide to considerations when choosing pharmaceutical mixing equipment and vendors for a facility.

  5. Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids

    Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.

  6. Determining And Controlling Oxygen Levels In Sensitive Formulations

    This webinar will review how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.

  7. The Keys To Superior Containment In Compounding Applications

    This paper reviews why very bad things happen when either quantity or purity of Highly Potent Active Pharmaceuticals is not properly maintained during the compounding process. Additionally, when highly potent active pharma ingredients are not effectively contained, workers may be adversely affected.

  8. Non-destructive Moisture Analysis Of Freeze Dried Product

    This webinar describes how non-destructive headspace moisture analysis can be used for characterizing batch moisture distributions, for lyo cycle development and optimization, and for freeze dryer moisture mapping and validation.

  9. New Guidelines For Container Closure Integrity Testing

    Increased regulatory scrutiny and exciting new analytical technologies have altered the landscape of container closure integrity testing. In order to provide guidance to this new environment the US Pharmacopoeia revised Chapter <1207> Sterile Product Package Integrity.  View this webinar recording to learn about the new guidelines and how they will impact your approach to sterile product package integrity.

  10. Introduction To Laser-Based Headspace Inspection And The Application To 100% Container Closure Inspection

    Gain insight into the process, ensure the maintenance of sterility for finished product after capping, and meet current regulatory guidance using laser-based headspace inspection.