Human beings will always pose the biggest risk of contamination. This means careful attention needs to be given to the likely movement patterns and workflow of your operational staff.
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.
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.
| 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 |
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.
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:
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.
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:
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).
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.
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:
You will also, of course, need to plan for mechanical room space, which could be anywhere from 250-1500 square feet.
ALUMA1 Modular & Flexible Cleanroom Systems are the go-to choice for organizations with demanding cleanrooms, such as Dalton Pharma, PharmHouse, and Baylis Medical.
Ready to discuss your project? You can reach out to us at [email protected] or by calling 1.866.625.8621.
