Our previous posts shared knowledge about clean room supplies, clean room technology. And the clean room classifications and standards. But do you know how to how to test the clean room? And what is the clean room testing procedure? What are the clean room testing standards?

As we all know, the production environment has great relations with the product quality, especially for the food manufacturing industry and pharmaceutical industry. That’s why the FDA clean room requirements are very strict. In this post, we will share with you all the information about clean room testing. 

Our company is a professional cleanroom supply manufacturer since 2005. With about 16 years of experience, our clean room system can pass the third party’s testing. We mainly produce clean room air filters, clean room purification equipment, and cleanroom furniture. Ok, now let’s dive into the clean room testing post. 

What is the clean room testing procedure?

The cleanroom certification process will have two main testings: usage modeling and test planning process and statistical testing and certification process. As you can see in the below flow chart image, these two processes are at the end of the workflow beforehand the key to the customer. 

 

What is the clean room testing equipment?

There are several kinds of monitoring test types of equipment, and they have different advantages. Below are the testing equipment styles:

Handheld Particle Counters

Handheld particle counters provide spot-checking over smaller, localized areas for proactive assessments on a day-to-day basis.

Handheld Particle Counters

Remote Particle Counters

Small particle counters connect to a dedicated facility monitoring system (FMS) and thus do not require on-screen displays.

Portable Particle Counters

Portable Particle Counters

Portable particle counters handle a higher airflow volume than handheld units and provide a dedicated solution for long-term data collection.

Remote Particle Counters

Vane Anemometers

Vane anemometers measure velocity and volumetric flow rate for industrial ventilation systems and cleanroom HVAC systems.

Vane Anemometers

Hotwire Anemometers

Hot Wire Anemometers operate best when air velocity is low or near standard air conditions. Commonly used in HVAC ventilation testing.

Hotwire Anemometers

What are the cleanroom testing standards?

Well, the cleanroom testing standards will be according to the ISO or the US FED STD standards. Please note these two standards have different grades. The US FED STD grade one equals the ISO grade 3. Please kindly check the below image for more information.

cleanroom cleanliness iso standards

cleanroom cleanliness iso standards

Clean room inspection checklist

Since the clean room inspection is a system work, it’s best to have an inspection checklist. We have listed below 14 points for your reference. 

  1. Stakeholder consultations
  2. Clean Room Grade
  3. Protrusions
  4. HVAC Ducts
  5. Power Supply to Site
  6. Equipment
  7. Power Supply
  8. Lighting
  9. Containment
  10. Change rooms
  11. Dust explosions
  12. HVAC filters
  13. Surfaces
  14. Waste Flow

GMP clean room guidelines

Good manufacturing practice (GMP) is a system for ensuring that the product’s production process is consistent and controllable. Its destination is to minimize the risks involved in any pharmaceutical production, which are difficult to eliminate through testing the final product.

We have found the EU GMP guidelines, and you can download them here: Sampling Programme For GMP Environments Final Version.

Clean room levels certification

The third-party will carry out the clean room testing, and they will send the certificates to the applicant. Below are the sample of the clean room levels certificate.

clean room testing certificates

 

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