Establishing Single-Use Assemblies on Filling Equipment: A Case Study

摘要

Biotest is a worldwide-operating company specializing in innovative hematology and immunology products with the holistic approach of a global pharmaceutical and biotherapeutics group. The company's products are used to treat life-threatening diseasessuch as coagulation disorders (hemophilia), severe infections, and disorders of the immune system.The most important starting material for Biotest's pharmaceutical products is human blood plasma, which is processed into medicinal products at a production facility in Dreieich, Germany. The company has explored using single-use assemblies as part of aneffective manufacturing strategy.Single-use assemblies provide major advantages during clinical supply filling, when timing can be critical. A company can experience cost and time savings by eliminating cleaning and sterilization validations from project lead-in time. Some time-consuming cleaning and sterilization steps are not required because sterile single-use assemblies are used directly, allowing for significantly shorter process and set-up times.