Tips for particle concentration compliance under ISO 14644-1:2015

Ensuring that your cleanroom is compliant with the new standard is a must. Here are a few tips to help you make that happen. Read on to determine changes you need to make to your work environment as soon as possible.

Shop for the right tools

Tests will need to be conducted to check if your cleanrooms follow compliance guidelines. That indicates the need to invest in calibrated instruments, including fogging machines, that can determine cleanliness of your cleanroom, the European Pharmaceutical Review says. Choosing the right distance and the processes that need to be monitored are also important, the R&D Magazine says. Keep these things in mind when you test your cleanrooms.

Pick a trusted supplier

When you look for instruments to help you test if your cleanrooms are compliant with the ISO 14644 standard, go over options from trusted suppliers. Pick a company that’s been in the business for a long time. That’s one way to find reputable suppliers for the testing instruments you need.

Check the number of particles for cleanroom class

Check the number of particles set for related cleanroom class. Use the table on ISO classes of air cleanliness, with the classifications determined by particle concentration.

Look for changes

Before you use the table, make sure you check for any changes. The particle diameter has been changed for ISO classes 1 and 2 as well as 3 and 5. You’ll need to keep those changes in mind before you carry out any tests or exams.

Determine minimum sample locations

Before you proceed with any tests, be sure to check the information on minimum sample locations. Figure out if this is going to affect your cleanrooms or not. If you have no problem following the requirement, then go right ahead to the next step.

Ditch the calculations

With a table, you won’t need to make an upper confidence limit calculation between 1 to 9 locations, at least not with any statistical calculations any longer. All you will need to do is the counting. That should make for less effort and work on your end.

Use the ISO 21501-4

When you carry out the test for your cleanrooms, make sure you base the calibration upon the ISO 21501-4, with the frequency as well as method of calibration should be based on practice, one that’s current and accepted. However, that doesn’t automatically mean there is no longer any room for non-compliant particle counters in the note section. Some cannot be calibrated. If that happens, you’ll need to make a note of your decision to use the counter in your test report.

Determine the tube length

Tube lengths for the particle counters must be determined. Some manufacturers of particle counters send over a 3 m sampling tube. But if a tube of this size comes with cranks and too many bends, then that will lead to particle loss in the tubing. That’s why it may be better for you to go for a transit tube that is as short as possible.


Ensure compliance in your cleanrooms. Make sure you follow these tips.



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