Cost Analysis Of Terminal Sterilization And Aseptic Processing Methods Of Sensitive Implantable Combination Drug Device Products

摘要

Executive SummaryududCost Analysis of Terminal Sterilization and Aseptic Processing Methods of Sensitive Implantable Combination Drug Device Products ududCompany XududZenabu Bawa-Mamudu ??? 4/24/2015ududProfessional Science Master???s in Biotechnology, California State University San MarcosudududSterilization is the validated process and method of ensuring that a product after production and packaging is free of microorganisms. Sterility can be achieved through both terminal sterilization which ensures the Sterility Assurance Level of 10-6 level or Probability of Non-Sterile Unit of less than 10-6 and aseptic processing which ensures the equivalent of 10-3. The Sterility Assurance Levels (SAL) is the statistical probability of a microorganism surviving during the process (Mosely, 2008). udSterilization science continues to pursue the most effective means of sustaining this regulatory requirement. This is driven in large part by the evolution of sensitive combination products that cannot tolerate the harsh conditions of terminal sterilization. Division 1 and Division 2 are divisions of Company X, a biotechnology company that specializes in the manufacturing of implantable combination drug and medical devices for use in ophthalmic, cardiac, and vascular care and intervention. Trends in sterilization sciences directly impact Company X across all divisions. Observing these trends and influences enables the company to proactively adapt to changes that impact both existing as well as future products. udThe project investigated the cost of development, validation, and implementation of different sterilization models. The aim of the project was to also provide metrics to be applied as a measurement tool. The metric can be used in making knowledge based decisions on the most cost effective and time efficient sterilization modality for next generation of combination drug device products that meets Regulatory requirements for Sterility Assurance Level. The project closely examined the different terminal sterilization modalities adopted by Division 1 and Division 2, which includes Ethylene Oxide (EO) and Radiation (E-Beam) sterilization, as well as Aseptic processing methods for sensitive implantable combination drug and device. An analysis was performed using Company X combination drug and device products as models to represent the different sterilization modalities. A series of interviews and tours were completed to gather data, analyze, and compare the sterilization validation and production cost.udThe following sterilization cost evaluation metrics was developed, Production Sterilization Distribution Time, Sterilization Process Time, Sterilization Cost per Unit, Annual Sterilization Capacity, and Sterilization Method Revalidation Cost and an analysis was performed using these metric and measurements. The analysis showed significant differences between the three sterilization modalities. The overall results indicated that the E-beam Radiation sterilization method provided the lowest Production Sterilization Distribution Time, Sterilization Process Time, Sterilization Cost per Unit, Sterilization Method Revalidation Cost, and Labor Cost. E-beam Radiation also provided the highest Annual Sterilization Capacity when compared to Ethylene Oxide and Aseptic Processing methods. The approach and metrics developed in this project have application in investigation of cost effectiveness of other sterilization methods. udFurther research can use the developed metrics to evaluate sterilization methods for a range of Sterility Assurance Levels (SAL) that are deemed safe and on site sterilization models such as Hydrogen Peroxide (H2O2) and Nitrogen Dioxide (NO2), that offer similar if not the same advantages as on site E-Beam.