Publications by authors named "Izumi Saitoh"
To establish a simpler and more reliable method for retaining the aseptic condition of freeze-dried bulk product of a drug substance, a helium leak test method was developed. The bulk product is for the new kit system for infusion of our antibiotic product. In manufacturing the kit system, the bulk product needs to be transported outside of the aseptic area.
View Article and Find Full Text PDFHelium leak test for sterility assurance of a sealed bag. I: Relationship of helium leak and pinhole diameter.
PDA J Pharm Sci Technol
August 2002
Article Synopsis
- The text outlines a method to keep drug substances sterile during the manufacturing of a dual-compartment infusion kit, which separates the infusion liquid from the drug product.
- The method involves using an aluminum laminate bag inside a polyethylene bag to ensure aseptic conditions, with a test for detecting leaks using helium.
- Results indicated that pinhole size significantly affects helium leakage, with effective detection of small holes, confirming experimental data matched theoretical calculations.