Managing Viable vs. Non-Viable Particles in Cleanrooms

For industries where minimizing contamination is critical, such as biotechnology, semiconductor manufacturing, pharmaceuticals, and healthcare, cleanrooms are vital. One of the biggest challenges in maintaining cleanroom conditions is keeping particles under control that could compromise the product’s safety and quality. These particles come in two varieties: viable and non-viable. In this blog, we’ll examine the distinctions, impacts, and useful ways to handle of these particles.

Understanding Viable and Non-Viable Particles

Viable Particles: Living microorganisms, including fungi, yeast, and bacteria, are referred to as viable particles. In sectors like pharmaceuticals, where patient safety and product quality are extremely important, these microbes can multiply in the right circumstances. Microbial sampling methods, such as settle plates, contact plates, and air samplers, are frequently used to detect viable particles.

Non-Viable Particles: Inert particles, such as dust, skin flakes, fibers, and other minute detritus, are classified as non-viable particles. Non-viable particles can contain live particles and function as vectors for microbial infection even if they are not living. Particle counters are commonly used to quantify non-viable particles, with particular attention paid to tracking particles with sizes between 0.5 µm and 5 µm.

Sources of Particles in Cleanrooms

Personnel: A significant source of both viable and non-viable particles is human activity. Skin flakes, hair, fibers from clothing, and respiratory emissions can all be major sources of pollution.

Materials and Equipment: Both kinds of particles can be introduced by packaging, inadequately sterilized equipment, and incoming materials.

Air Supply: The cleanroom may become infiltrated by particles from the surrounding environment due to inadequate filtration or airflow.

Processes: Particles produced during manufacturing operations including filling, transferring, and mixing can add to the particle load in the cleanroom.

Managing Non-Viable Particles

Maintaining cleanroom classifications and making sure that viable particles have fewer surfaces to attach to are dependent on managing non-viable particles. Important tactics for managing non-viable particles include of:

High-Efficiency Particulate Air (HEPA) Filters: A HEPA filter can remove 99.97% of particles smaller than 0.3 µm. Reducing non-viable particle counts requires HVAC systems with HEPA filters that are properly designed and maintained.

Airflow Control: Preserving unidirectional airflow, also known as laminar airflow, reduces the dispersion of particles and guarantees their prompt capture by HEPA filters. Achieving a low particle count requires careful consideration of the airflow’s direction and velocity.

Cleaning and Disinfection Protocols: For particle collection on surfaces to be minimized, regular washing and disinfection are necessary. To prevent creating extra particles, non-shedding cleaning agents and appropriate methods must be applied.

Material Selection: Reducing contamination primarily requires the use of materials and equipment designed to reduce particle production. For cleanroom settings, smooth, non-porous surfaces that don’t shed are perfect.

Particle Monitoring: Real-time data on non-viable particle levels can be obtained through continuous particle monitoring with laser particle counters. This information is useful for verifying ISO classification conformance and evaluating the efficacy of control mechanisms.

Managing Viable Particles

In businesses where microbiological contamination could threaten patient safety and product sterility, effective particle management is essential. Among the successful methods for limiting viable particles are:

Personnel Training and Gowning: One of the main sources of viable particles is human personnel. Strict gowning practices can greatly lower microbiological contamination. These practices include the use of sterile gloves, masks, and coveralls.

Environmental Monitoring: To find signs of microbial contamination, regular environmental monitoring is necessary. Techniques such as active air sampling, passive air sampling (settle plates), and surface sampling (contact plates) are used to detect live particles.

Disinfection Procedures: Disinfection is essential to getting rid of microbes. Using sporicidal chemicals and rotating disinfectants can assist stop the growth of resistant bacteria populations. The effectiveness of every cleaning product against the intended organisms should be confirmed.

Maintaining Differential Pressure: Contaminated air cannot migrate between cleanroom zones if the differential pressure is maintained properly. By ensuring that air moves from clean to less clean places, positive pressure helps lower the possibility of viable particle penetration.

Restricted Access: Contamination is less likely to enter cleanrooms when access to materials and staff is restricted. Only individuals who are properly gowned and permitted should be able to enter the cleanroom, according to established procedures.

Monitoring Viable and Non-Viable Particles

It is essential to monitor both viable and non-viable particles in order to keep a cleanroom environment. Frequent monitoring helps detect possible problems before they get worse and guarantees that contamination levels are within allowable bounds. Common methods of observation consist of:

Non-Viable Particle Counting: Real-time measurements of airborne non-viable particles are made using laser particle counters. Keeping up with ISO 14644 compliance depends on these measures.

Viable Particle Monitoring: Viable particles are found using settle plates and microbial air samplers. In order to evaluate how clean the walls, equipment, and work surfaces are, surface sampling is also done.

Data Analysis and Trending: Continual surveillance produces vast amounts of data. Examining patterns, looking into anomalies, and putting remedial measures in place when necessary are all aided by trend analysis over time.

Conclusion

In cleanrooms, controlling both viable and non-viable particles is crucial to preserving the integrity of the controlled environment and guaranteeing the safety and quality of the products. Industries can reduce the danger of contamination and comply with regulations by comprehending the distinctions between these kinds of particles and putting in place efficient control systems.

Effective particle control requires a comprehensive strategy that incorporates improved filtration, airflow management, disinfection, staff training, and diligent monitoring. Continuous enhancement of these procedures will assist satisfy the more demanding requirements of contemporary industry as cleanroom technology advances.

If you’re looking for expert guidance on your cleanroom projects, we’re here to help. ACH-A Cleanroom Hub offers comprehensive solutions tailored to meet the unique requirements of your industry, from pharmaceuticals to electronics manufacturing. Our team of specialists is ready to assist you at every stage of your cleanroom build. Get in touch with us today to explore how we can support your project and ensure your cleanroom meets all necessary standards and expectations. Let’s connect and bring your cleanroom vision to life!