What is a Cleanroom ISO 14644 Standards?

Posted by Amos Fred on July 17th, 2019

The cleanliness of the air is used to classify cleanrooms, ISO Clearance Standards says. That is to say, the number and size of particles permitted for every volume of air are crucial in getting the room classified. Because cleanroom ISO 14644 standards make use of a specific particle count in the laboratory’s air, understanding the chapter will help ensure better compliance for your facility.

Definition of ISO 14644

This is a set of regulations that specifies classes of air cleanliness based on the number of particles present in a concentration of air volume, the PDA says. As a standard method, it is also known as another method for testing to identify the cleanliness class of your facilities or cleanroom areas.

Revision purposes

The general 14644 standards were revised to provide an updated version of standards as required by companies in the industry. The revision has also set out to simplify the classification process. That includes the removal of any need to evaluate the 95% upper confidence limit for low sample location. The revision has made it possible to make changes to ensure that the classification procedure applies to today’s clean room operations.

Instrument calibration

To prevent cross-contamination, you will need to start calibrating your instruments. A valid calibration certificate is a must. The frequency, as well as the method of calibration, must be dependent on currently accepted practices.

Replacing instruments

However, if you start seeing signs that your instruments are damaged in any way, don’t proceed. Replace all that with new instruments. That will ensure a better outcome. If you persist in using non-compliant instruments, then that is going to lead to more problems and issues for your facility.

Shopping for instruments

You can prevent compliance issues by replacing your instruments. If you have instruments that don’t quite fit the bill, then it may not provide you with the results you want. Get the outcome that favors you by replacing your instruments with better options from a clean room equipment provider.

Choosing a supplier

Not all equipment suppliers are alike, though. You need to find out more about the firm before you move forward with any buying decisions for tools and equipment designed for cleanrooms and associated controlled environments. For instance, how old is the company? How long has it been around? What kind of products does it offer? If it focuses on cleanroom products, then that is a good sign.

Doing your homework

Aside from replacing instruments in your clean room, do your homework. Don’t stop researching your options. You can save on costs when you partner with a trustworthy equipment supplier for your clean room needs.

Conclusion

Use the best practices for contamination control. Upgrade, revise or replace your clean room equipment to ensure strict and stringent processes. The revised ISO standards now require companies to employ stricter measures in keeping their clean rooms clean and sterilized. While that’s going to present a few more challenges, the results are well worth it, especially in preventing contamination and improving patient safety levels.