Technical Paper Series
Cleanroom Product Selection:
Recommended Practices
This technical paper series explains how controlled environments should develop criteria for the selection of critical cleanroom products; gloves, wipers, and garments in accordance with IEST Recommended Practices, ASTM, and ANSI Standards.
The series emphasizes the significance of
- Performance Criteria
- Specification Process
- Testing methods
Navigating Cleanroom Standards:
A Comprehensive Guide to Organizations, Regulations, and Associations
This technical paper series provides a comprehensive overview of the entities such as;
- General Standard Organizations (IEST, NIST, ASTM, ANSI, NEBB)
- Controlled Environment Focus Standard Organizations (ISO, IEST and ICCCS)
- U.S. Government Agencies (DOD, FDA, USDA and NASA)
- Life Science NGOs and Industry Trade Associations
- Advanced Materials NGOs and Industry Trade Associations
Standard Operating Procedures for Controlled Environments
Standard Operating Procedures (SOPs), or work instructions, are the foundation of quality management systems across industries. They provide consistent, detailed instructions for operations, covering materials, methods, equipment maintenance, and administrative tasks. Clear SOPs ensure compliance, uniformity, and high-quality standards, creating a unified company knowledge base and consistent corporate culture.
The FDA Code of Federal Regulations (CFR) mandates written SOPs and document controls for all life science operations. Written SOPs demonstrate compliance with quality, cleanroom, industry standards, health, safety, environmental, and manufacturing regulations.
This technical series covers following chapters:
- Introduction to Writing Internal SOPs for Controlled Environments,
- Optimizing Cleanroom Operations: SOPs for Gowning Protocols,
- SOPs for Cleanroom Operator Requirements and Training,
- SOPs for Facility Maintenance, Cleaning, and Sanitization,
- SOPs for Critical Cleaning.
Innovative Solutions for Critical Environments