West’s Tech Forum helps customers better understand the many technical issues they deal with each and every day. From regulatory and compliance to product knowledge and service, West has the answers our customers’ need – and we’ll be posting them right here on Tech Forum.
Check back often for news and updates – including information on where and when West experts will be presenting as well as new scientific posters and podcasts.
New Posts
Enhance Closure Safety with Vision InspectionAn international biotherapeutic company was recently cited in a 483 letter from the Food and Drug Administration (FDA) regarding the presence of black particles in its drug product. The company had failed to properly inspect for particulate. Learn how vision inspection can help solve this issue.
FDA Takes Action on Drug/Container InteractionInteraction of a drug product with the container closure system can impact patient safety and the resulting contamination may not be manifested as a particle. Interaction products are often soluble in the drug product and may go undetected if extractable and leachable studies are not conducted. Learn how to prevent interaction issues.
Recent PostsJoin West at the 2010 PDA Extractables and Leachables WorkshopEvaluation of piston movement and container integrity under severe storage conditions in plastic and glass prefilled syringesDevelopment of an Assay to Determine Protein Sensitivity to Tungsten and to Investigate the Effects of pH and Ionic Strength on Aggregation
Sterility Issues Receive Warning LettersA Novel Cryopreservation System for Dental Pulp-derived Mesenchymal Stem Cells
Challenges with Combination Drug Delivery Systems: Pre-filled Syringes and Auto Injectors
Minimizing the Variation of Volume Withdrawn from a Container for Injectable Drug Products and Impact to Overfill
Evaluation of Residual Moisture in Lyocakes and Corresponding Lyophilization Stoppers of Different Rubber FormulationsCharacterization of Prefillable Syringe Systems for Biopharmaceutical Drug Delivery
Polini to Speak at PharmaEd Container Conference – January 25, 2010
Regulatory Emphasis on Process Validation
Innovations in Container Closure Systems and New Industry Technologies