The dye ingress test method is a routine test for container closures attached to parenteral drugs and large molecule drugs. Traditionally, this method uses ten test samples and three positive controls. During this testing, the test samples are place in a vacuum chamber and pressurized with dye. Three vials are punctured to allow dye to … Read more
During the manufacturing process of injectable drugs, all pieces and parts need to go through a visual inspection process. The container, closure, product and final product all need to have individual inspections. Container closure integrity is extremely important, especially when involved with parenteral drugs. Parenteral drugs have the highest risk packaging application concern for closure … Read more
Trisha Gladd, Editor for Life Science Connect, wrote an article for Pharmaceutical Online. Which talked about the rise of FDA recalls due to the presence of particulate matter in injectables. Trisha interviewed vice president of quality assurance at West Pharmaceutical Services, Bob Nase, who stated that the process of creating and filling the injectable drugs … Read more