8 Steps in Creating an Efficient and Compliant Cleanroom

A well-thought-out and well-designed cleanroom will ensure that you can maintain a high level of industry compliance, operational efficiency, and cost-effectiveness. However, a poorly designed cleanroom will only frustrate you will ongoing issues, while it hemorrhages spendings.

To ensure you’re doing things correctly, here are 8 steps you need to follow to create an efficient and compliant cleanroom.

1. Staff and Material Flow

The cleanroom’s workers will pose the biggest risk of contamination. This means careful attention needs to be given to the likely movement patterns and workflow of your operation.

Your cleanroom’s most critical zone should only be accessible via a single point, which prevents any traffic to or from less critical spaces.

You also need to plan for how/where materials will be handled by defining your raw material inflow routes and finished product outflow routes.

2. Classification

Your cleanroom’s ISO class is determined by the concentration of particles of various sizes ranging from 0.1 microns to 0.5 microns.

Today’s common ISO standard 14644-1 (ISO 5, 6, 7, 8) replaced the Federal Standard 209 classification (Class 100; Class 10,000; Class 100,000) in 1999 before being updated in 2015.

There are still organizations that utilize and recognize the Class 100; Class 10,000; Class 100,000 terminology.

Comparing ISO standard 14644-1 to Federal Standard 209

ISO Standard 14644-1 Federal Standard 209
ISO 3 1
ISO 4 10
ISO 5 100
ISO 6 1,000
ISO 7 10,000
ISO 8 100,000

3. Pressurization

To further prevent contamination, your cleanroom will likely be positively pressurized. Your pressure cascade should see the highest level cleanroom with the highest pressure. An adjacent cleanroom with a lower classification would have lower pressure. Next, your growing room would have even lower pressure. And finally, the non-cleanroom area would have the least.

4. Determine Airflow

Your cleanroom’s class (ISO 5-6-7-8, GMP A-B-C, etc) defines the cleanliness level required.

However, the other factors will include:

  • The number of people working in the cleanroom and their movement
  • How much and the type of equipment, furniture, and instruments inside the cleanroom
  • The size of your cleanroom
  • The number of rooms within your cleanroom
  • Estimated heat gain

An online air changes per hour (ACH) calculator can give you a very rough ballpark number, but these tools don’t factor in any of the variables above.

5. Air Exfiltration Flow

A 1% to 2% volume leakage rate is acceptable for a well designed and well-sealed cleanroom

You need to account for exfiltration into adjoining spaces having lower static pressure through:

  • Electrical outlets
  • Light fixtures
  • window frames
  • Access and door frames
  • Wall/floor/ceiling interfaces

6. Space Air Balance

You also need to determine how you will maintain space air balance by accounting for the airflow entering the space (supply, infiltration) and all the airflow leaving the space (exhaust, exfiltration, return).

7. Temperature, Humidity and Other Environmental Factors

To ensure your staff is comfortable and productive under their protective attire, you will want to keep a temperature range between 19-21 degrees celsius.

In a stringent cleanroom setting, temperature and humidity must be as precise as ±0.25°C and ±2% in a cleanroom setting.

8.Mechanical System/Room Layout

Many of the areas we’ve already discussed will dictate how your mechanical system is laid out. Of course, there are always other factors such as:

  • Spatial availability/ constraints
  • Funding and budget
  • Process requirements
  • Required reliability

Energy/ utility cost

  • Building/zoning codes
  • Local climate

You will also, of course, need to plan for mechanical room space, which could be anywhere from 250-1500 square feet.

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