ISO Cleanroom Standards to Stay Compliant
lab worker looking through microscope

Over 70% of cleanrooms worldwide comply with ISO 14644 standards, which shows that people take them very seriously. In the US, for example, OSHA provides oversight and can issue regulatory fines. However, the possibility of contamination, product failures, or other issues can weigh heavily on a business.

With that in mind, are there any other ISO cleanroom standards you should pay attention to or specific ISO 14644 elements you need to enforce more carefully than others?

Reading this article, you will find a structured ISO standards guide that will help you understand how specific ISO cleanroom standards work, including:

  • ISO 14644-1 to ISO 14644-5
  • ISO 14644-8
  • ISO 14698-1 and ISO 14698-2

Use this information to break down key requirements and help you match global benchmarks. Read on to ensure cleanroom compliance and maintain safety and quality in your facilities.

ISO 14644-1: Cleanroom Classification and Compliance Standards

ISO 14644-1 defines a cleanroom and what it does. It also determines what specific level of cleanroom it is, from ISO 1-9, with “1” being the most strict in its lack of contamination. The ISO standard establishes clearly defined acceptable levels of airborne particulates, meaning that anyone wishing to follow them must follow steps to ensure air cleanliness is at its peak.

Following this standard might include leveraging:

  • Air filtration
  • Better gowning processes
  • More stringent material handling
  • Regular assessments or audits

Facilities must maintain a log of their meeting this standard to prove compliance. Their data should also include when there is both movement and no movement to ensure the shifting of dust due to air currents is taken into account.

ISO 14644-2: Ensuring Ongoing Compliance Through Monitoring

ISO 14644-2 specifies how an organization should monitor its cleanroom or clean zone. It discusses minimum requirements and defines the level of care to be taken during monitoring.

This requirement states that monitoring does not need to be continuous. However, it should happen regularly, and the rule specifies “sequential” or “periodic” monitoring.

The standard also discusses “alert levels” and what should happen when contaminant levels exceed defined quantities.

ISO 14644-3: Testing and Verifying Cleanroom Performance

High-quality cleanroom certification and monitoring testing methods are imperative to ensure you can meet or maintain the requirements set by other ISO regulations. These standards demand several tests, including:

  • Particle testing
  • Airflow measurement
  • Pressure differential tracking
  • Filter integrity and efficiency tests
  • Airborn particle size distribution checks
  • Air change rate assessments

These validation processes must repeat occasionally, as even minor changes can impact whether you comply with the standards. To ensure compliance, you must also demonstrate that you meet these standards, so strict documentation is essential. Fortunately, companies such as KHA offer various forms of document upkeep software to help ensure such documentation does not go out of date.

ISO 14644-4: Design and Construction for Maximum Compliance

These steps clearly define what guidelines you should be developing when it comes to both designing and constructing cleanrooms. They address aspects such as:

  • Material selection
  • HVAC requirements
  • Air handling processes
  • Layout optimization
  • Accounting for contamination control

The standard offers recommendations not only for the internal space but also for constructing the walls, floors, and ceilings. These must ensure that they do not accumulate particulates and should be easy to clean repeatedly to ensure any resting debris or dust does not remain.

Airflow should also be optimized to ensure that HVAC systems offer the greatest functionality and enable proper filtration. Similarly, the placement of airlocks and pressure-controlled areas must allow for seamless functionality and a low likelihood of contamination.

Once the construction is complete, the documentation and designs should remain on file. This effort ensures compliance with regulatory bodies such as OSHA and allows for simpler upgrades or ongoing adaptation to changing regulations and the operational needs of the cleanroom. These are something that a cloud-based system like what KHA offers can often do with little effort.

ISO 14644-5: Operational Protocols for a Compliant Cleanroom

These protocols define how a company should design cleanroom processes and operations to prevent contamination, either on purpose or by accident. It expands on creating protocols for areas such as:

  • Clothing options for preventing human-led contamination
  • Personnel training expectations
  • Monitoring of those using the cleanroom to ensure compliance
  • How to maintain or move equipment
  • What the criteria for appropriate equipment are
  • Personal cleaning procedures
  • Location maintenance and inspection procedures

Together, these steps offer a strong likelihood of maintaining a controlled and audited cleanroom environment. They prevent possible contamination caused by human activity.

ISO 14644-8: Airborne Molecular Contaminants (AMC)

AMC limits define how much airborne molecular contamination can be detected in any area at once. It discusses concepts including:

  • Volatile organic compounds (VOCs)
  • Organic solvents
  • Inorganic vapors (e.g., acid gases)
  • Acidic fumes
  • Basic fumes
  • Condensable contaminants
  • Siloxanes

The standard specifies how one should test for these materials and the nature by which locations must conduct routine audits or assessments. In addition, it lists the levels at which different contaminants will trigger specific alarms that require employers to take action.

ISO 14698-1 and ISO 14698-2: Microbial Control in Cleanroom Environments

These standards outline the steps a company should take to ensure a cleanroom remains free from contaminants. These steps are essential because microorganisms pose serious threats to cleanroom integrity. The health of those using products created in such a space is also at stake, so these rules are rigorous. 

ISO 14698-1 and ISO 14698-2 clearly define how microbial monitoring should occur and what to do depending on the results. The testing procedures should also be comprehensive and result in the ability to create a sanitized environment.

The ISO standard also defines how risk assessments should occur. They allow facilities to identify microbiological issues they may face and mitigate them.

Non-compliance with these standards can often result in product recalls or regulatory action, including significant fines. Therefore, facilities must ensure they record the steps they take to maintain microbial control.

Ensuring Long-Term Compliance with ISO Cleanroom Standards

Ensuring you maintain ISO cleanroom standards is not a single action. Maintaining a cleanroom’s certification takes ongoing work, meaning you need to monitor, document, and update your procedures regularly.

KHA offers solutions for this process to streamline both compliance and training to ensure all workers can follow these requirements. Their tailored environmental management and training software makes getting your team up to speed easier than ever. So, get in contact to learn what we can do for you and ensure your next OSHA audit goes smoothly.