Selecting the cleanroom classification primarily involves matching
the sensitivity of the production process to particles and
microorganisms. Here's a clear decision framework for you:
1. Clarify your core needs
First ask yourself: What does your product fear the most? Is it
micron-level dust or invisible microorganisms? This determines
whether you should follow the ISO standard (for particle control)
or the GMP standard (which addresses both microorganisms and
particles). For example, chip manufacturing fears dust, while
biopharmaceuticals fear microorganisms.
2. Refer to typical industry classifications
Different industries have established conventions, which serve as a
great starting point:
ISO Class 1-3 (Class 100/1,000): Semiconductor lithography and
production of high-end medical device implants, with zero tolerance
for sub-micron particles.
ISO Class 5 (10,000): Used for sterile pharmaceutical filling and
precision optical component manufacturing, requiring strict
microbial control.
ISO Class 7-8 (Class 100,000): Suitable for food packaging and
general medical device assembly, meeting basic dust control
requirements.
ISO Class 9 (Class 100,000): Suitable for raw material storage and
simple assembly, with relatively low cleanliness requirements.
3. Consider three practical principles
Precision Matching: Avoid blindly pursuing high cleanliness levels.
For instance, a food raw material warehouse only requires a Class
100,000 standard, while a chip lithography area must meet a Class
100 standard.
Reserve for Upgrades: If future process improvements are possible,
design with reserved space and piping interfaces to reduce later
renovation costs.
Regional Differentiation: Divide the same workshop into
different-grade zones, such as a "Class 100,000 raw material area +
Class 10,000 packaging area," which meets requirements while
reducing costs.
4. Focus on key parameters
In addition to the rank, it also depends on:
Air change rate: For Class 100 (ISO Class 4), it should be ≥200
times/hour; for Class 100,000 (ISO Class 7), approximately 15-20
times/hour.
Temperature and Humidity Control: Typically maintained at 18-24°C
and 45-65% humidity.
Pressure differential design: Prevent contamination from
low-cleanliness areas to high-cleanliness areas.
5. Seek Professional Support
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