How to Classify a Clean Room Effectively: 1 Minute to Mastering Clean Room Classification

Properly classifying a clean room is fundamental for industries such as pharmaceuticals, electronics, medical device manufacturing, and aerospace where controlling contamination is critical. Clean room classification refers to categorizing the environment based on the concentration of airborne particles and cleanliness standards, primarily following ISO 14644-1 or, in some industries, the older FED-STD-209E standard. Here’s an effective step-by-step approach to classify a clean room:

1. Understand Standards: Familiarize yourself with common standards like ISO 14644-1, which specifies the allowable number of particles per cubic meter at different particle sizes. For instance, ISO Class 5 is much stricter than ISO Class 8.
2. Set Operational Parameters: Determine the clean room’s intended use, necessary cleanliness level, and any specific processes or sensitive equipment present. This ensures the classification aligns with actual needs.
3. Conduct Airflow and Pressure Analysis: Measure air changes per hour, airflow patterns, and pressure differentials. Consistent, unidirectional airflow helps maintain cleanliness by sweeping particles away.
4. Perform Particle Count Testing: Using calibrated particle counters, measure airborne particles at representative locations within the clean room under both “at rest” and “in operation” conditions.
5. Analyze Data Against Standards: Compare test results against classification limits set by standards like ISO 14644-1. The clean room gets its classification based on the largest number of particles measured at the specified sizes.
6. Document and Maintain: Document all testing procedures and results. Ongoing monitoring and periodic recertification ensure continued compliance with the designated class.

From a designer's point of view, efficient clean room layout and spatial planning are pivotal in maintaining cleanliness standards. Seamlessly designed flow paths for people and materials, integrated airlocks, and separation of clean and less clean areas all contribute to sustained classification performance. Utilizing digital tools for precise floor planning enhances both compliance and operational efficiency while future-proofing the space for potential upgrades.

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Involve multidisciplinary teams—including facility managers, designers, and process engineers—early in the clean room planning and classification process. Their combined expertise ensures all technical, operational, and compliance needs are met from the outset.

FAQ

Q: What is the primary standard used for clean room classification?

A: The most widely recognized standard is ISO 14644-1, which outlines classes based on particle counts per cubic meter at various particle sizes.

Q: How often should a clean room be reclassified?

A: Clean rooms are typically reclassified or recertified annually, or whenever significant changes occur in the facility or processes.

Q: What’s the difference between “at rest” and “in operation” conditions in clean room testing?

A: “At rest” means the clean room is complete with equipment installed but not operational, while “in operation” refers to testing when personnel and processes are active.

Q: Can digital tools help with clean room classification?

A: Yes, digital 3D planning and simulation tools can optimize layout, airflow analysis, and operational workflows, aiding in efficient classification and compliance.

Q: Why is ongoing particle monitoring important in a clean room?

A: Continuous monitoring alerts operators to contamination events, ensuring standards are maintained and helping quickly address deviations.