Far-UVC and ISO 14644 Compliance in Cleanrooms

Maintaining air and surface cleanliness is a top priority in pharmaceutical cleanrooms, where even the smallest microbial contamination can compromise product integrity. ISO 14644 is the international standard that defines cleanliness classifications and contamination control requirements for cleanrooms. To meet these strict standards, pharmaceutical companies must adopt effective solutions to mitigate microbial contamination. One such solution is Far-UVC technology.

Understanding ISO 14644 and Its Revisions

ISO 14644 is a series of standards that define the classification and operational guidelines for cleanrooms and controlled environments. The standard was introduced in 1999 and has since undergone several revisions to enhance contamination control measures.

Key Revisions and Their Impact

• ISO 14644-1:2015 – This revision refined the particle concentration requirements for cleanrooms, eliminating the need for the 5-micron particle size class in higher-grade cleanrooms (ISO 5 and cleaner). The revision also introduced updated sampling methods to ensure compliance.

• ISO 14644-2:2015 – Focused on monitoring requirements, this revision emphasized continuous and periodic assessment methods to ensure cleanroom compliance over time.

• ISO 14644-3:2019 – Provided updated guidance on cleanroom test methods, including microbial monitoring strategies.

• ISO 14644-4:2022 – A recent revision that enhances recommendations for cleanroom design and construction, ensuring that new technologies can be integrated into contamination control measures.

These updates highlight the growing need for advanced contamination control solutions, and Far-UVC technology presents a novel and effective approach.

The Role of Far-UVC in Cleanroom Contamination Strategy

Far-UVC light (222 nm) is an approach to microbial control in cleanrooms. Unlike traditional UVC light at 254 nm, which poses risks to human health and contains mercury, Far-UVC is safe for occupied environments while effectively inactivating airborne and surface microbes.

Key Benefits of Far-UVC in Cleanrooms

1. Decontaminate Gowned Cleanroom Operators before entering the Cleanroom - With Far-UVC Cleanroom operators can enter the Cleanroom clean.

2. Continuous Air and Surface Decontamination– Far-UVC light provides ongoing microbial control, reducing the risk of contamination between cleaning cycles.

3. Safe for Human Exposure – Studies have shown that 222 nm Far-UVC light does not penetrate human skin or eyes, making it a viable option for use in occupied cleanroom environments.

4. Reduction of Airborne Contaminants – By inactivating airborne pathogens, Far-UVC helps maintain the stringent microbial contamination limits required by ISO 14644.

5. Enhances Existing Cleaning Protocols – While traditional cleaning methods focus on removing particles, Far-UVC adds an extra layer of microbial defense.

6. Minimizing Downtime – Continuous decontamination allows cleanroom operations to proceed with fewer interruptions for deep cleaning.

Far-UVC Solutions for Cleanroom Compliance

UV Medico provides Far-UVC solutions designed specifically for cleanroom applications. Our products seamlessly integrate into existing cleanroom infrastructure, offering an additional layer of protection against microbial threats. Here’s how our key products help meet ISO 14644 requirements:

UV222 Booth

The UV222 Booth is a standalone Far-UVC decontamination unit designed to provide localized microbial control in high-risk areas. This solution is particularly beneficial for:

• Personnel decontamination before entering cleanroom environments.

• Targeted decontamination zones within cleanrooms where microbial load is higher.

• Supplementing gowning procedures with an additional layer of contamination control.

Learn more about the UV222 Booth

UV222 Step-On

The UV222 Step-On is a standalone foot-activated Far-UVC device designed for the targeted decontamination of footwear. It ensures that personnel entering the cleanroom do not introduce microbial contamination from their shoes. The key benefits include:

• Effective Shoe Decontamination reducing the risk of microbial transfer from footwear into cleanrooms.

• Standalone or Combined Use – Can be used independently or in conjunction with other Far-UVC solutions like UV222 Booth for comprehensive personnel decontamination.

• Personnel simply step on the unit for a quick and automated Far-UVC exposure to ensure shoes are decontaminated before entry.

Learn more about the UV222 Step-On

Cleanroom Downlight

The Cleanroom Downlight is a ceiling-integrated Far-UVC lighting system that continuously disinfects air and surfaces in cleanrooms. Its key advantages include:

• Seamless integration with existing cleanroom lighting systems.

• Continuous 222 nm Far-UVC exposure to maintain microbial cleanliness in compliance with ISO 14644.

• Low maintenance requirements, providing a cost-effective contamination control measure.

Learn more about the Cleanroom Downlight

Vertex 222

Vertex 222 is a flexible Far-UVC solution designed for various cleanroom environments, featuring:

• Adjustable installation options for optimal decontamination coverage.

• A combination of air and surface microbial reduction strategies.

• Ideal for areas where traditional UVC systems cannot be safely used.

Learn more about the Vertex 222

How Far-UVC Enhances Compliance with ISO 14644

ISO 14644 mandates strict control over airborne and surface contamination, and Far-UVC technology directly addresses these requirements. By continuously inactivating airborne and surface pathogens, UV Medico’s Far-UVC solutions offer:

• Increased Cleanroom Sterility – Helping maintain ISO 14644 class limits by reducing microbial contamination.

• Reduced Cleaning Burden – Minimizing reliance on manual decontamination procedures.

• Enhanced Monitoring Compliance – Supporting the continuous monitoring requirements introduced in ISO 14644-2:2015.

Pharmaceutical companies operating cleanrooms under ISO 14644 regulations must leverage advanced technologies to ensure compliance and maintain high-quality production environments. Far-UVC technology is a game-changer in microbial control, offering continuous, safe, and effective decontamination. UV Medico’s Far-UVC solutions, including the UV222 Booth, Cleanroom Downlight, and Vertex 222, provide an innovative way to support cleanroom cleanliness, ensuring regulatory compliance and product safety.