The Standards For Cleanroom Validation
- View 10
If you want to keep your facility clean and safe, it is important for you to put cleanrooms to use. As the name suggests cleanrooms are areas that are designed to keep certain particulate matter and contaminants out of the room. No matter what industry in which you operate, you can probably benefit from a cleanroom. However, if you really want to take full advantage of this space, it is important for you to get it validated. What is cleanroom validation, and what is the process like? Remember to rely on experienced professionals who have the tools and training necessary to properly validate your cleanroom.
Why Cleanrooms Are Important
Your cleanroom has a direct impact on the health and safety of your employees. By removing particulate matter from the air, you reduce the chances of your employees getting sick.
Cleanrooms also have a direct impact on the efficiency of your manufacturing processes. Without a suitable cleanroom, your production may suffer.
Your cleanrooms also have a direct impact on your rates of customer satisfaction. If you are unable to keep up with their demands, your satisfaction rates may suffer, harming your reputation.
If you want to take full advantage of these benefits, you must make sure you understand the standards related to cleanroom validation. What do you need to know?
The Standards for Cleanroom Validation
If you want to get your cleanroom validated, there are several standards you need to meet. They include:
You need to show that the air supplied to your gmp cleanroom for medical devices will either remove or dilute any contaminants present in the room.
You also need to show that the air is clean enough that it will not add to the contaminants that are present in the room.
You must ensure that the air in the cleanroom moves from an area that is clean to an area that is less clean, and not the opposite.
The validation test will also have to show that the air movement within the room takes place in such a way that there are no pockets of concentration that could heighten the contaminant levels in that specific part of the room.
Finally, you will also need to show that your manufacturing processes can be completed in an environment that does not add to the contaminants in the room.
If you want to show that your cleanroom meets all of these standards, it is important for you to get it validated by a team that understands how this process works.
The Process of Getting Your Cleanroom Validated
When people think about medical device cleanrooms validation, they usually think about counting particles. Even though this is an important part of the process, there is so much more that has to be done to ensure that your cleanroom meets the right standards. If you want to get your cleanroom validated, there are several tests that need to be completed. They include:
An airborne particle count test
An airflow test
An air pressure differential test
An airflow direction test
A filter leakage test
A humidity test
A flow visualization test
A recovery test
A contaminant leak test
A temperature test
These tests can be complicated, and you need to work with a professional team that has experience in this area. It might even be beneficial to work with a team prior to designing your cleanroom. That way, you can get the design qualified properly which can streamline the process in the future.
After these tests are done, your cleanroom will be classified according to ISO standards. There might be certain standards that need to be met depending on the industry in which you work, so you should be familiar with the different classifications. If there is a specific classification you need to meet, you may want to work with a professional team that can make this happen.
That is where we can help you. At Kwang Cleanroom, we are familiar with the latest standards, and we can help you design your cleanroom in such a way that you meet all relevant standards in your industry. Rely on our team to assist you.
If you want to get your cleanroom validated, there are certain steps you need to follow. At Kwang Cleanroom, we can streamline the process for you, making it as easy as possible for you to follow cleanroom compliance and get your cleanroom validated. We can also advise you on certain types of equipment you may want to use to make your blow molding film purification cleanroom as clean as possible. We can make it easier for you to design your cleanroom appropriately. reach out to us to speak to our team about how you can get your cleanroom validated.