September 14, 2021

How to Ensure Your Cleanroom Meets All Regulatory Inspections

You’re investing a lot of time and money into your cleanroom. The last thing you want is to find out you need to invest even more because it’s non-compliant in any way, following a regulatory inspection.

Issues found during inspections are often expensive and can lead to a lot of wasted time.

For example, your airflow rates and patterns need to be compliant, as they are critical to protecting people and processes in a critical environment such as a Cleanroom.

This is why you need to ensure that your system is HEPA filtered and meets the particulate control specifications, while hitting the laminar airflow rates with static pressures.

Let’s take a look at how SMARTHEPA Filters can ensure you’re always compliant.

The Volume of Air Supplied and the Velocity

Insufficient airflow, velocities or turbulent patterns will create more issues and endless troubleshooting of a system that ultimately isn’t in control.

Regulatory agencies look for a few key points to make sure a Cleanroom meets the regulatory requirements:

  1. Air Balancing reports to confirm sufficient volumes and velocities of air are supplied and air change rates are sufficient
  2. The air volumes are then further confirmed through Environmental Monitoring and validation results for both particulate and microbial contamination
  3. Smoke Studies showing a visual demonstration of the airflow patterns and that the critical process locations are protected by unobstructed laminar flow “first-air” over those areas

A suitable HEPA filter ensures you’re meeting and maintaining these standards across the board. Selecting Cleanroom HEPA filtration specification is straightforward, using industry standard MERV specifications.

Fan Filter Power

It can be even more challenging to select Fan Filter Modules that:

  • Provide sufficient power
  • Provide enough control
  • Can fit into the design space

SMARTHEPA excels at providing ample fan horsepower with Modbus control. It is also easily adjustable, without having to disrupt the physical facility configuration. They also deliver consistent performance and airflow rates. They can handle challenging applications to overcome significant static pressures.

This gives you a broad range of control for precise setpoints that easily meet the laminar airflow patterns and velocity requirements.

“We have replaced a number of older style HEPA fan filters with SMARTHEPAs, which provide better airflow control and fit into an existing tight plenum space,” said Jim Kanaris,.

He added that, “SMARTHEPAs have helped increase the airflow and actually hit the 90 FPM required for regulatory requirements.”

The larger horsepower ECM fan motor provides exceptional energy efficiency and the extra power sometimes required to overcome static pressures within a facility design.

If you have any other questions about SMARTHEPA technology or how it can help you, please click here to contact us any time.

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