INSIGHTS ON QUALITY CONTROL

• 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.

• Container Closure Integrity Testing Method Development

  Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

• Industry Survey: Best Practices In Container Closure Integrity Testing

  Container closure integrity (CCI) plays an important role in maintaining the sterility and stability of sterile injectable products. This article summarizes the answers to polling questions that were presented to representatives of pharmaceutical companies involved in CCIT activities.

• Container Closure Integrity Of Sterile Vials During Deep Cold Storage

  Learn how rapid, nondestructive laser-based headspace analysis can support with data generation to demonstrate the maintenance of seal integrity during deep cold storage and transport.

• The Definitive Guide To Porosity Characterization

  This paper takes an introductory look at the techniques used to investigate porosity, the data generated and their strengths and limitations for specific materials, covering more complex approaches such as the Reverberi method and the application of non-local density functional theory (NLDFT) to illustrate the necessity for, and potential benefits of, more advanced analysis.

• Rotational Viscometer ViscoQC 300 & PTD 80

  Developed for a wide range of applications, ViscoQC 300 ensures the quality of your substance – from almost any fluid to semi-solid samples – by delivering fully traceable viscosity results right at your fingertip.

• CCI Testing And Revisions To EU Annex 1

  The new language in EU Annex 1 will likely have a significant impact on your CCI testing practices. In this webinar CCI testing strategies and the proposed revisions to EU Annex 1 are discussed.

• 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.

• Oxygen Permeation In Pre-Filled Syringes

  This webinar presents how to design and conduct studies to assess the total oxygen permeation rate of your pre-filled syringes, and how to determine if the permeation is primarily through the plunger or through the tip.  Protecting oxygen-sensitive formulations during filling will also be discussed.