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Clean room technologies of the 1990s
1Cogito Consult AB, Angelholm, Sweden.
Summary
This review covers 40 years of cleanroom standards and guidelines, highlighting benefits from cross-industry learning in this complex technology. It updates on current standards development.
Area of Science:
- Contamination Control Engineering
- Industrial Microbiology
- Regulatory Science
Background:
- Cleanroom design and operation is a complex, multidisciplinary technology with broad industrial applications.
- Cross-sectoral awareness of cleanroom advancements can yield significant benefits.
- Historically, advancements have occurred across diverse industries utilizing controlled environments.
Purpose of the Study:
- To provide a comprehensive review of cleanroom technology developments over the past four decades.
- To consolidate information on general, medical device, and pharmaceutical industry standards.
- To offer an update on ongoing efforts in new cleanroom standards development.
Main Methods:
- Literature review of historical developments in cleanroom technology.
- Analysis of general and industry-specific cleanroom standards (medical device, pharmaceutical).
- Survey of current activities related to new standards.
Main Results:
- A historical overview of cleanroom design and operation advancements spanning 40 years.
- Compilation of key standards and guidelines relevant to various industries.
- Identification of emerging trends and ongoing work in standards creation.
Conclusions:
- Understanding cleanroom advancements across different sectors is crucial for technological progress.
- Existing standards provide a foundation, but continuous updates are necessary.
- Active participation in standards development ensures relevance and addresses future needs.