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A cleanroom technician in full blue sterile garments, safety goggles, and a face mask writes on a clipboard inside a controlled environment with stainless steel surfaces.

Introduction to Writing Internal SOPs for Controlled Environments

This is Chapter 1 of Valutek's Technical Paper Series:
Standard Operating Procedures for Controlled Environments
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Overview

Whether you manage production workflows, enforce quality protocols, or oversee facility sanitation, this chapter offers a practical and standards-aligned roadmap for creating SOPs that support repeatable, validated outcomes.

Drawing from FDA CFR Title 21, ISO 14644, and IEST Recommended Practices, this chapter explore the structure and life cycle of effective SOPs within controlled environments.

By the end of Chapter 1, readers will understand how to:


  • Develop SOPs that promote uniformity and reduce risk
  • Align documentation with operational and compliance objectives
  • Establish sustainable review, revision, and training protocols

"Clear and concise SOPs ensure compliance and maintain uniformity and consistency in the quality of products and services across all levels of an operation."


Explore More Resources

Continue deepening your understanding of SOPs for controlled environments:
Jan Eudy is a cleanroom/contamination control and microbiological subject matter expert with more than 30 years of industry experience in semiconductor, microelectronics, pharmaceutical, biopharmaceutical, medical device, food manufacturing, compounding pharmacies, aerospace, and automotive. As the corporate quality assurance manager for Cintas Corp., Jan oversaw research and development, directed the quality system and ISO registration at all cleanroom locations, and supported validation and sterile services. During her time with the company, Jan also implemented and maintained the HACCP risk management program at all Cintas industrial laundries. She is also a Past President and Fellow of the Institute for Environmental Sciences and Technology (IEST).

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