Parenterals should be manufactured and inspected to ensure the highest quality, meeting the requirements set forth in the United States Pharmacopoeia (USP) Chapter Injections.
As they are typically injected, parenterals have the potential to go directly into the bloodstream which can result in adverse reactions to contamination and particulates. Particulate matter in finished pharmaceuticals can come from multiple sources, such as the ingredients in the drug product, processing equipment, or the container closure system.
As a final step in the manufacturing process of parenterals, visual inspection is necessary to reduce or eliminate the risk of non conformities in the released products. The special features of a filled bag (soft, warm, potential risk of air intrusion, etc) make very difficult to inspect automatically those products and therefore most of the IV fluid companies perform that task in a manual or semi-automatic way.
Particulate matter in parenteral solutions can be detected through BRAM-COR systems with black/white background for human inspection:
Containers closed by fusion, should be subject to 100% integrity testing. Various non-destructive leak inspectrion methods are available. Our force squeezing leak test solution (CCI - Container Closure Integrity test) is operated through a semi-automatic machine.
