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Technical Paper Series

 
A Cleanroom operator adjusting his/her safety goggles.

Cleanroom Garment Programs: A Comparative Analysis of Launderable and Limited Use Solutions

Selecting the right cleanroom garment system is not a one-size-fits-all decision. It depends on factors like cleanroom class, manufacturing processes, and operational needs, including the number of operators and proximity to laundry services. Understanding garment washing processes is also crucial, as it ensures proper material use and maintains garment integrity.

Deciding between owning and leasing cleanroom garments involves weighing cost, control, and flexibility. Ownership offers long-term savings and control but requires a higher initial investment, while leasing provides flexibility with lower upfront costs but may be more expensive over time.

This technical paper series is divided into three essential parts to help you select, manage, and procure cleanroom garments effectively:

  • Selecting a Cleanroom Garment System
  • Managing a Launderable Cleanroom Garment Program
  • How to Procure Cleanroom Garments

 

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Banner: Standard Operating Procedures Technical Paper Landing Page

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.

 

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Banner: Valutek Cleanroom Product Selection Recommended Practices Technical Paper

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
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Banner: Valutek Navigating Cleanroom Standards Technical Paper

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
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Innovative Solutions for Critical Environments

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