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What is a 100,000 Class Clean Area?
A 100,000 class clean area, as defined by the ISO 14644-1 standard, is a controlled environment where the maximum allowable particle concentration is 100,000 particles per cubic meter for particles sized 0.5 microns or larger. In practical terms, this means that within this clean area, the air quality must be maintained to comply with specific cleanliness levels suitable for various industrial and laboratory applications. This classification is particularly common in environments such as pharmaceutical manufacturing, biotechnology, and Electronics, where contamination control is essential.
The 100,000 class clean area is typically characterized by its ventilation system, which must provide a sufficient amount of air changes per hour to dilute and remove airborne contaminants. Usually, this translates to at least 10 to 20 air changes per hour, depending on the specific application and design of t
he clean room. The air is filtered using High-Efficiency Particulate Air (HEPA) filters, ensuring that particles are effectively trapped before circulating back into the space.
In addition to airborne particle control, a 100,000 class clean area must have strict protocols regarding personnel attire and behavior to minimize contamination risks. Personnel must wear appropriate cleanroom garments, including gowns, gloves, masks, and shoe covers, to prevent the transfer of particles from clothing and skin. Regular cleaning and maintenance schedules are also crucial to uphold the cleanliness of the environment.
Monitoring systems should be in place to continuously measure particle counts and other environmental parameters, such as temperature and humidity. This ensures compliance with the cleanliness requirements and allows for immediate corrective actions if standards are not met. Overall, the 100,000 class clean area plays a crucial role in industries where product quality and purity are paramount.
Related Standards and Guidelines:
ISO 14644-1: Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness
iso 14644-2: Cleanrooms and Associated Controlled Environments – Part 2: Monitoring to Provide Evidence of Cleanroom Performance Related to Aircleanliness
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
What is Clean Area Classification?
Clean area classification refers to the systematic categorization of controlled environments based on the cleanliness levels of the air within those spaces. The classification is determined by the concentration of airborne particles, with specific limits set for different particle sizes. The most widely recognized standards for CleanRoom Classification are established by iso 14644-1, which divides clean areas into classes ranging from ISO1 (the cleanest) to ISO9 (the least clean). For example, ISO ISO 5 allows a maximum of 3,520 particles (≥0.5 µm) per cubic meter, while ISO Class 100,000 permits up to 100,000 particles. These classifications are essential in industries such as pharmaceuticals, biotechnology, and aerospace, where even minimal contamination can compromise product quality or safety. Compliance with these classifications ensures that clean areas meet the necessary requirements for the intended applications, helping to maintain product integrity and reliability.
| Class | Max Particles (≥0.5 µm) per m³ |
|---|---|
| ISO 1 | 10 |
| ISO 5 | 3,520 |
| ISO 6 | 35,200 |
| ISO 7 | 352,000 |
| ISO 8 | 3,520,000 |
| ISO 9 | No specific limit |
How to Determine Cleanroom Class?
Determining the cleanroom class involves several steps. The process requires careful measurement and analysis of airborne particle concentrations, as well as compliance with established cleanliness standards.
1. Initial Assessment: The first step is to conduct an initial assessment of the intended CleanRoom environment. This includes understanding the specific requirements of the processes or products that will be handled within the cleanroom.
2. Selection of Standards: Identify the relevant standards, such as ISO 14644-1, to guide the classification process. The chosen standard will dictate the acceptable levels of particle concentration for the intended cleanroom class.
3. Air Sampling: Perform air sampling using calibrated particle counters. These devices measure the concentration of airborne particles in real-time or through periodic sampling over a designated time frame, typically during operational conditions.
4. Analysis of Results: Analyze the collected data to determine the concentration of particles of varying sizes, particularly those larger than 0.5 microns. This analysis will help identify the cleanroom's particle count against the limits set by the relevant classification.
5. Comparison with Standards: Compare the results with the classification criteria outlined in the applicable cleanroom standards. If the particle counts fall within the limits for a particular cleanroom class, it can be classified accordingly.
6. Documentation: Document the findings and classification results thoroughly. This documentation should include details of the air sampling methodology, results, andthe classification determination, as this is essential for compliance and for future audits.
7. Periodic Reevaluation: Cleanroom classifications are not a one-time determination. Regular monitoring and reevaluation are necessary to ensure continued compliance with the established cleanroom class. This includes routine air sampling and maintenance checks to identify any changes in the cleanroom environment that could affect cleanliness.
By following these steps, facilities can ensure that their cleanrooms are accurately classified, allowing them to maintain the necessary standards for their operations and protect product integrity.
What Are the Requirements for a 100,000 Clean Room?
A 100,000 clean room, classified under ISO standards, has specific requirements that must be met to maintain its designation and functionality. The first requirement is related to air cleanliness. According to ISO 14644-1, a 100,000 clean room must not exceed 100,000 particles per cubic meter for particles measuring 0.5 microns or larger. Maintaining this standard involves using high-efficiency filtration systems, such as HEPA filters, which remove a significant percentage of airborne particles from the air.
Secondly, the design and operation of the clean room are critical to meeting the cleanliness criteria. The clean room must be equipped with a robust ventilation system that typically provides 10 to 20 air changes per hour. This ensures that contaminants are continually removed and replaced with filtered air. Additionally, the layout should facilitate smooth airflow patterns, reducing dead zones where particles can accumulate. Surfaces within the clean room must be constructed from non-porous materials that are easy to clean and resistant to microbial growth.
Lastly, personnel protocols play a significant role in maintaining the clean room environment. All personnel entering the clean room must follow strict gowning procedures, which include wearing cleanroom-approved garments, gloves, masks, and shoe covers. These measures minimize the risk of introducing contaminants from outside the clean room. Training for personnel on cleanroom protocols and hygiene is also essential to ensure compliance and maintain the integrity of the clean area.
FDA Classification of Clean Rooms
The FDA classifies clean rooms primarily based on the level of contamination control required for sterile drug manufacturing and other sensitive pharmaceutical processes. The classification system used by the FDA is aligned with the ISO standards, particularly in terms of air cleanliness levels and environmental controls. Here’s a breakdown of the FDA classification:
1. Class A Clean Rooms
These are the highest classification, suitable for aseptic operations. They must maintain a maximum of 3,520 particles per cubic meter (≥0.5 µm) and require the strictest controls, including laminar airflow systems and continuous monitoring.
2. Class b Clean Rooms
Used for supporting operations in aseptic processing, they typically allow up to 29,000 particles per cubic meter. These rooms must be designed to maintain cleanliness during the manufacturing of sterile products, with controlled airflow and strict gowning protocols.
3. Class C and D Clean Rooms
These classes are used for less critical operations. Class C allows up to 352,000 particles per cubic meter, while Class D allows up to 3.5 million particles. These clean rooms are often used in the early stages of pharmaceutical production or for the packaging of non-sterile products.
4. Regulatory Compliance
The FDA requires that clean room environments comply with Current Good Manufacturing Practices (cGMP). This includes regular monitoring, validation of air quality, and adherence to strict cleaning and maintenance schedules to ensure ongoing compliance with the designated class.
5. Documentation and Validation
Facilities must maintain thorough documentation of environmental monitoring results, cleaning protocols, and personnel training. Regular validation of the clean room's performance is also required to ensure that it consistently meets FDA standards.
What is the Highest Class Clean Room?
A designated clean area is a controlled environment specifically designed to minimize contamination and maintain strict cleanliness standards, often found in settings such as laboratories, manufacturing facilities, and healthcare environments.
These areas are crucial for processes that require a high degree of sterility, such as pharmaceutical production, Semiconductor fabrication, and surgical procedures. The design of a clean area incorporates various features, including controlled airflow, specialized ventilation systems, and materials that can withstand rigorous cleaning protocols.
The air quality is meticulously monitored, with particulate matter and microbial levels kept to a minimum, often achieved through the use of high-efficiency particulate air (HEPA) filters. Additionally, personnel entering these areas typically undergo strict gowning procedures to prevent the introduction of contaminants.
The clean area may be classified into different cleanliness levels, such as ISO classes, which dictate the maximum allowable particle counts for various sizes. This classification helps organizations adhere to industry standards and regulatory requirements, ensuring that products and processes are not compromised by contamination.
Overall, the creation and maintenance of designated clean areas are essential for ensuring product quality, safety, and reliability in sectors that demand the highest levels of cleanliness.
