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The importance of cleanroom validation

30 August 2023MediaHugo Woudsma

Do you know whether your cleanroom still meets the desired ISO class?

Managing Director Niels Ferguson explains: “Due to use, aging, contamination or damage to components, it is possible that the cleanroom no longer achieves its desired ISO class. A higher than desired ISO-class can have very adverse effects on the work process and end product(s).”

For example:

  • More time and effort may be required to clean the end product to the correct specifications (Grade 4 and Grade 2 specs, for example). Which results in a lower production speed.
  • Larger amount of cleaning products are needed to achieve the desired specifications. Which results in higher production costs per product.
  • The product can become contaminated after cleaning and inspection, before it is packaged.

“Cleanroom – Room in which the concentration of airborne particles is controlled and classified, and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the area.”

Ref. International standard ISO14644 first edition 2015.

Cleanroom Standard Cleanroom Classification Guidelines
ISO 14644-1 Class 3 Class 4 Class 5 Class 6 Class 7 Class 8
Federal Standard 209E 1 10 100 1.000 10.000 100.000
EU GGMP – – A/B – C D
Air changes / hour 360-540 300-540 240-480 150-240 60-90 5-48
Validation interval

According to ISO14644-1:2015, cleanroom and flow cabinet have to be validated in accordance with a maintenance and validation program tailored to the individual process.

In practice, this usually leads to a validation interval of 12 months of cleanrooms with ISO class 6 or higher. For cleanrooms or flow cabinets with ISO class 5 or lower, the validation interval is usually 6 months.

ProCleanroom validation
In consultation, our qualified CTCB-I engineers can perform the test below:

  • Particle counts (concentration of airborne particles) – standard
  • Measurement of air velocity
  • Measurement of light intensity (lux)
  • Air Changes (circulation rate)
  • Pressure difference test
  • Aerosol smoke visualisation test
  • Measurement of noise – sound pressure level (dB (A))
  • Temperature and humidity measurements
  • HEPA or ULPA filter integrity test/efficiency test (Aerosol challenge/DOP test)

Selected Airborne Particulate Cleanliness Classes

For cleanrooms and clean zones shown in ISO 14644-1:2015

ISO Classification Number Maximum concentration limits (particles/m³ of air) for particles equal to and larger than the considered sizes shown below
≥0.1µm ≥0.2µm ≥0.3µm ≥0.5µm ≥1.0µm ≥5.0µm
ISO Class 1 10 – – – – –
ISO Class 2 100 24 10 – – –
ISO Class 3 1.000 237 102 35 – –
ISO Class 4 10.000 2.370 1.020 352 83 –
ISO Class 5 100.000 23.700 10.200 3.520 832 –
ISO Class 6 1.000.000 237.000 102.000 35.200 8.320 293
ISO Class 7 – – – 352.000 83.200 2.930
ISO Class 8 – – – 3.520.000 832.000 29.300
ISO Class 9 – – – 35.200.000 8.320.000 293.000
Do you want a cleanroom or flow cabinet that continues to perform according to the specifications? Then make an appointment!

ProCleanroom also validates fixed cleanrooms by other suppliers.
𝗣𝗿𝗼𝗖𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺: 𝗕𝘂𝗶𝗹𝗱 𝘆𝗼𝘂𝗿 𝗲𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲.

Get in touch with our specialists.

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Tags: cleanroom, cleanroom technology, ISO class, precision technology, ProCleanroom, validation

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ISO class-7 cleanroom for Cyberfreight Pharma Logistics

17 December 2018Hugo Woudsma

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