Many Advantages. Drug developers need to manufacture large quantities of material in the shortest period of time in order to meet their goal of getting their drug into the clinic. Often there is limited time available for scale-up and optimization of the process. Single-use, disposable processes and components offer many advantages for drug developers.
Ready to Use. Disposable components are clean and ready to use when supplied which mitigates the need for sterilization and decreases the requirement for formerly essential services such as water for irrigation systems and steam generators.
Eliminate Cross Contamination. Disposable components are single-use only and therefore not used for subsequent operations, eliminating the chance of cross contamination or product carry-over between process runs.
Shorter Timelines. Long lead times for equipment installation are avoided because the need for stainless steel equipment is reduced or eliminated.
Reduction in Complex Systems Costs. Systems are less complex, resulting in fewer engineering requirements and elimination of clean-in-place or steam-in-place operations along with the associated piping, valves, controls and pressure rating of vessels.
Validation Benefits. Employing single-use components greatly reduces the complexity of validation. As there are substantially fewer reusable components, fewer items need to be tracked and extensive validation studies for sterilization and cleaning are eliminated.
Rapid Systems Reconfigurations. By eliminating most, if not all, hard piping and stationary tanks, single-use components allow for operations to be more rapidly reconfigured for new process runs.
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