Clean Steam Energy Conservation Process Design

Abstract

Abstract ― The objective of this article is to design the sterilization methodology and processes needed in a product or equipment that requires the injection of clean steam to create a sterile environment. Clean steam is preferred over plant steam which is created by the boilers carrying undesirable contaminants and additives that may be in contact with the product or equipment. The use of clean steam in pharmaceutical manufacturing is determine by Good Manufacturing Practices (GMP) and ruled by the Code of Federal Regulations CFR Title 21, Part 211[1]. These general rules will not provide any specific recommendation regarding the steam, but focusing on facility, operations, equipment, and systems requirements. The clean steam purity is defined by the purity of the condensate that is often referenced with water purity standards. Steam sterilization is injected to a piping to create a sterile environment or into an autoclave were components are exposed to it.