Any cleanroom’s walls, floors and ceilings hold the potential for issues such as leaks, pressure loss, and contamination.
Compliant walls should be made of an easy-to-clean and non-shedding material. They can be gypsum board with a seamless coating on metal studs, or they can also be modular.
Meanwhile, a cleanroom’s floors can be:
And finally, your ceiling requires a special factory gasketed (or gel) grid system to support the HEPA filters, lights, and panels.
You need to ensure your system is in control of your airflow, velocities or patterns.
Regulatory agencies look for a few key points to make sure a cleanroom meets regulatory requirements:
Regulatory agencies also need to see critical process locations are protected by unobstructed laminar flow “first-air” over those areas.
Your cleanroom’s air will be filtered through HEPA (High-Efficiency Particulate Air) or ULPA (Ultra Low Particulate Air) filters.
These filters are rated:
The Minimum Efficiency Reporting Value (MERV) measures the airborne contamination threats that can pass through a filter. HEPA filters range from MERV 17 at 99.97% up to MERV 20 at 99.999%.
A HEPA filter supplies an airflow of anywhere from 400 to 700 Cubic Feet Per Minute (CFM). For example, if your cleanroom is ISO 7 classified and 10’ x 15’ x 8’ in size, it will require 1,000 CFM and 2 HEPA filters, if itneeds 50 air changes per hour.
|Required AirflowCubic Feet Per Minute (CFM)||Number of HEPA filters(1 HEPA = 500 CFM)|
|13 333 CFM||27|
|1 000 CFM||2|
To ensure the accuracy of processes and constant compliance, your temperature and humidity need to be tightly controlled and monitored. They must be as precise as ±0.25°C and ±2%.
Both of these numbers can be heavily influenced by:
Your cleanroom will need specially constructed and airtight lights. They are typically 70-100 foot candles, and they will give off heat that you will have to account for.
You will also need to account for the cleanability of all the light fixtures, switches, and electrical outlets, being mindful of tiny nooks and crannies that can trap moisture or bacteria.
Compliance actually begins in the design stage. By building your cleanroom or critical environment correctly the first time, you can make maintaining compliance considerably easier.
Work with a firm that has proven success in your industry. 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.