_______________ Air Exchange Rate Effect on Hydrogen Peroxide Gas Decontamination Cycle Turnaround Times
This paper evaluates a few design issues to show how a hydrogen peroxide gas decontamination cycle can be optimized before executing the biological challenge.
_______________ Case Study: Physical and Microbiological Testing of a Locally Controlled Environment Filling System at Merck Manufacturing Division
Physical limit testing is discussed including a study of the relationship between particulate ingress through a mousehole at various operating pressures. Data from a 7-day simulated media fill reveals a very robust system for contamination control.
_______________ Hydrogen Peroxide Gas Sterilization Trials Performed on a Prototype Enclosed Vial Filler
Feasibility testing performed on a prototype vial filler isolator to determine if the system could be decontaminated using hydrogen peroxide gas. BI sterilization, isolator aeration, and sterilant ingress data are presented.
_______________ Simulated Media Challenge and Environmental Qualification for an Isolated Filling Line
Media fill and environmental qualification data is reviewed for an isolated filling line approximately two months prior to license application submission.
_______________ COMING SOON
Issues for Transferring Items between Isolators
Tips for Increasing Productivity in Sterility Testing Isolator Systems