Validation of every material and piece of manufacturing equipment in the biopharmaceutical industry is an expensive and time-consuming process, costing drug companies and contract manufacturers millions of dollars and delaying time-to-market for a new medication. To reduce the impact of this challenge, manufacturers have moved toward the use of disposable manufacturing equipment — bioreactors, chromatography columns, hold bags for storage, etc.

These products are part of a larger concept known as the “disposable factory” or “factory in a box.” These concepts are all part of the Six Sigma lean manufacturing best practices currently taking place in the pharmaceutical industry as well as many other industries.

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