INSIGHTS ON LIQUID DOSE MANUFACTURING

• 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.

• Toxic Treatments: Controlling Exposure Risks In ADC Manufacturing

  The potency and effectiveness of the ADCs are dependent upon engineered nanoparticles (ENPs), but little is known about the environmental and human health hazards posed by ENPs.

• The Challenges Batch And Continuous Manufacturing Bring To Containment Product Design

  Methods and techniques used in pharmaceutical manufacturing are broadly reviewed. There are two basic models of pharma manufacturing: batch and continuous. Both approaches are defined. It is concluded that both approaches have elements of the other. Generally speaking, many pharma manufacturing procedures are transitioning from the batch to the continuous approach.

• Recommended Blending Equipment For Nutraceuticals

  Dry blending is an indispensable operation in the manufacture of multivitamins, sports supplements, herbal extracts, meal-replacements, green food powders and other nutraceutical products.

• 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.

• 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.

• Nitrogen Purge Optimization And Validation Of Sterile Liquid Filling Lines

  Large molecule biopharmaceuticals can be prone to oxidation and to prevent this from occurring, the headspace is often purged with an inert gas during filling to ensure a longer shelf life.

• Scale-Up And Tech Transfer From 100 L SIP/CIP Vessel To The 300 L S.U.F.

  A collaborative study with a new customer with the objective of taking an existing, smaller preclinical E. coli process previously performed in stainless-steel vessels and scaling it up quickly.

• 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."