September 9, 2021

The 5 Most Crucial Aspects of Cleanroom Compliance

Regulatory compliance is never really achieved. It is maintained. Keeping your cleanroom in a constant state of compliance is the only way to ensure all inspections come and go uneventfully. This also ensures you’re constantly protecting the people and processes in your facility. A single airflow issue found in your cleanroom during a regulatory inspection can bring your productivity to a screeching halt, costing you massive amounts of lost revenue, productivity, and possibly even your brand’s reputation. Ensuring constant compliance is incredibly complex, with each respective industry presenting its own list of challenges. However, broadly speaking, these are the areas that most organizations will need to focus on to maintain constant compliance.

1. Walls, Floors, and Ceilings

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:

  • Poured seamless systems
  • Seamless sheet vinyl
  • Epoxy
  • Vinyl tile

And finally, your ceiling requires a special factory gasketed (or gel) grid system to support the HEPA filters, lights, and panels.

2. Airflow Rates and Patterns

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:

  1. Air Balancing reports showing that adequate volumes and velocities of air are supplied. They will also confirm that the air change rates are sufficient.
  2. Environmental Monitoring and validation results for both particulate and microbial contamination will also confirm air volumes.
  3. Smoke Studies providing a visual demonstration of the cleanroom’s airflow patterns.

Regulatory agencies also need to see critical process locations are protected by unobstructed laminar flow “first-air” over those areas.

3. Air Filtration

Your cleanroom’s air will be filtered through HEPA (High-Efficiency Particulate Air) or ULPA (Ultra Low Particulate Air) filters.

These filters are rated:

  • HEPA- 99.99 percent efficiency on 0.3 micron particles
  • ULPA- 0.128 micron particles

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 CFM27
1 000 CFM2

4. Environmental Controls

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:

  • How many staff members are working in the cleanroom
  • How staff will move within a zone, or from one zone to another
  • The equipment, furniture, and instruments required
  • The size of your cleanroom and the number of rooms within your cleanroom
  • Estimated heat gain from humans and equipment

5. Lights

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.

Industry-Leading Cleanroom Design and Installation Experts

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.

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