Tim Latham, MSc, C.Eng., MIChemE.

Course Outline

Clean steam is a utility service provided in facilities where contamination of products must be prevented, most typically in pharmaceutical manufacturing facilities producing sterile materials. Conventional plant steam contains boiler additives which can potentially cause contamination, and the purpose of clean steam is to avoid this. The requirement to produce chemically pure steam without additives leads to a number of significant differences from conventional steam systems, both in its generation and distribution.

This course examines the specifications for clean steam, relevant regulations, its uses, and the design and operation of generation and distribution systems.

This course includes a multiple-choice quiz at the end, which is designed to enhance the understanding of the course materials.

Learning Objective

At the conclusion of this course, the student should:

• Be aware of the uses of clean steam.
• Understand how impurities are defined and what they are.
• Be able to create a purity specification for clean steam.
• Be capable of outlining the differences between clean steam and conventional utility steam systems.
• Understand the fundamental principles for maintaining clean steam purity.
• Be familiar with the main types of clean steam generator.
• Understand the process and mechanical requirements for a clean steam distribution system.
• Be aware of the testing, supervisory and regulatory requirements for maintaining a clean steam system in operation.
• Understand the validation process for clean steam systems.
• Be aware of the principal regulations to which clean steam systems must conform.
  
  

Intended Audience

This course is intended for land surveyors, GIS professionals and engineers.

Benefit to Attendees

Process, piping, facilities and building service engineers involved in the design, validation or operation of clean steam systems in pharmaceutical manufacturing, hospitals or associated industries.

Course Introduction

Conventional utility steam is generated by heating water that has been treated with a variety of chemicals. These chemicals, which may include corrosion inhibitors and anti-scaling agents, as well as any contaminants in the original feed water, may be carried over into the steam. Usually utility steam is distributed in carbon steel piping, which rusts and contributes further contamination to the steam. Where the steam comes directly into contact with equipment or products, there is a risk of contamination with these chemicals.

In the manufacture of pharmaceuticals, and sterile materials in hospitals, steam is used for direct contact sterilization, usually in autoclaves but also sometimes for in-place sterilization of manufacturing equipment. Contamination of pharmaceutical and sterile medical products must be prevented, a requirement overseen in the USA by the Food and Drug Administration (FDA). In these industries, steam must be generated in a different way, from pure water and without the use of additives. It must also be distributed in systems which do not add contamination. Moreover, the process of sterilization depends upon the steam being saturated, and without superheat or significant non-condensable gases, and this presents further demands on the clean steam system design and operation.

The US Pharmacopoeia has defined standards for grades of water to be used in pharmaceutical manufacturing, namely Purified Water (PW) and Water for Injection (WFI). As yet there are no such defined requirements for clean steam, so each manufacturing organization must define its own appropriate specification for its clean steam, which must be such that the steam does not add contaminants to its products.

This course will:

• Review the types of contamination that can occur in steam, and the preparation of appropriate purity specifications that will meet the requirements of the FDA and other regulatory authorities.
• Describe the nature of clean steam generators, and explain the reasons underlying their design and the differences from conventional utility steam boilers.
• Describe the requirements for good steam distribution design that will ensure clean steam is delivered dry, saturated and at the appropriate purity to the point of use.
• Outline the regulatory requirements for validating, operating and maintaining a clean steam system.
  
  

Course Content

Once you finish studying the above course content, you need to take a quiz to obtain the PDH credits.