Insights On Quality Control

  1. 10 Considerations For Balance Stability

    Stability of your weighing balance is paramount when it comes to collecting reliable data for project. As the old adage goes, “Anything that can go wrong will go wrong.”. Depending on the problem, taking obvious action for a seemingly obvious solution may not result in success. The purpose of this paper is to inspire thought and dialogue regarding those “not so obvious” sources of balance stability issues. Below, you may find 10 prompt questions that will hopefully guide one in resolving those pesky head-scratchers.

  2. New Method To Quantify Redispersion Potential Of Al Salts In Vaccines

    Adjuvants such as aluminum salt (Alum) are commonly added to vaccines to enhance their immune responses. A resulting sediment can be more or less compact and difficult to redisperse depending on the strength of the bonds between particles. In this note, we propose a rapid evaluation method (less than 30 minutes) of the sediment redispersibility.

  3. Stopper 'Pop-Up' And The Effects On Container Closure Integrity Of Freeze Dried Vials

    Stopper pop-up resulting in loss of container closure integrity is not uncommon and impacts the stability, sterility and reconstitution of lyophilized product. Non-destructive headspace analysis is a powerful method for monitoring container closure integrity in finished vials of freeze dried product and for building quality into the manufacturing operation.

  4. Venting Fume Hood Base Cabinets — A Better Way

    Frequently, companies have used fume hood exhaust to ventilate hood base cabinets. There is both the need for this practice and the designs for them are frequently not well thought-out. 

  5. 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.

  6. Getting What You Need In A Laboratory Hood

    Understand what information you should be communicating to the manufacturer to ensure you get the best lab containment equipment, built correctly the first time.

  7. Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product

    This app note describes the application of the PULSAR inspection platform to perform 100% headspace oxygen monitoring during the filling of oxygen-sensitive formulations, 100% container closure inspection of suspect batches, moisture inspection of freeze dried product, and automated media fill inspection.

  8. Optical Rotation And Quality Control

    The optically active pharmaceutical and its mirror image are referred to as enantiomers. While they might possess identical physical properties, their physiological properties can differ dramatically. 

  9. 10 Worst Containment Engineering Mistakes

    Engineering is a process to develop a design to solve a problem. In the world of containment engineering, careful premeditation is important to the completion of a successful engineering project.

  10. 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."