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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2014)

Donning by Design: Sterile Cleanroom Gowning Evolves to Help Minimize Contamination Risk

Damon Larkin

Introduction: In the pharmaceutical industry, the investments needed to bring a product to market are staggering. In fact, it is widely reported that the fully capitalized cost to develop a new drug can range from $800 million to nearly $900 million. The steep price of product rejects and recalls makes it crucial to ensure high product yields by maintaining strict cleanroom cleanliness and sterility. That is one of the reasons that the U.S. Federal Drug Administration (FDA) mandates that any product that is injected, or used in the eyes or on open wounds must be sterile, i.e., free from viable microorganisms. That is because, if contaminated with microorganisms, these pharmaceutical products can adversely harm patients. 

 

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