Introduction

In the pharmaceutical industry, maintaining a clean and controlled environment is crucial to ensure product quality and patient safety. This is particularly important in sterile and non-sterile areas of pharma facility packaging and manufacturing. To achieve this, environmental monitoring is performed to assess the level of particulate contamination in these areas. The classification of filters used in these areas plays a vital role in maintaining the desired cleanliness levels. In this article, we will define the filter class for both sterile and non-sterile areas as per the ISO and FDA 209E table. We will also discuss the latest version of the standards and the permissible size of particulate matter in the current era.

Filter Class for Sterile Area

ISO (International Organization for Standardization) and FDA (Food and Drug Administration) provide guidelines for the classification of filters used in sterile areas. These guidelines help in determining the efficiency of filters in removing particulate matter of specific sizes. The latest version of the ISO standard for cleanrooms and associated controlled environments is ISO 14644-1:2015. It replaced the previous version ISO 14644-1:1999. According to ISO 14644-1:2015, there are various filter classes defined based on the maximum allowable concentration of airborne particles per cubic meter of air. The classification is as follows: - ISO Class 1: Maximum allowable particle concentration of 10 particles of size 0.1 μm or larger per cubic meter of air. - ISO Class 2: Maximum allowable particle concentration of 100 particles of size 0.1 μm or larger per cubic meter of air. - ISO Class 3: Maximum allowable particle concentration of 1,000 particles of size 0.1 μm or larger per cubic meter of air. - ISO Class 4: Maximum allowable particle concentration of 10,000 particles of size 0.1 μm or larger per cubic meter of air. - ISO Class 5: Maximum allowable particle concentration of 100,000 particles of size 0.1 μm or larger per cubic meter of air. It is important to note that the above classification is for particles of size 0.1 μm or larger. The standard also provides guidelines for monitoring particles of larger sizes.

Filter Class for Non-Sterile Area

In non-sterile areas, the requirements for filter class are relatively less stringent compared to sterile areas. However, it is still important to maintain a controlled environment to prevent contamination and ensure product quality. The filter class for non-sterile areas is defined by the FDA in its standard FDA 209E. The latest version of this standard is FDA 209E-2019. According to FDA 209E-2019, the filter class for non-sterile areas is determined based on the maximum allowable concentration of airborne particles per cubic foot of air. The classification is as follows: - Class 100,000: Maximum allowable particle concentration of 100,000 particles of size 0.5 μm or larger per cubic foot of air. - Class 10,000: Maximum allowable particle concentration of 10,000 particles of size 0.5 μm or larger per cubic foot of air. - Class 1,000: Maximum allowable particle concentration of 1,000 particles of size 0.5 μm or larger per cubic foot of air. Similar to the ISO standard, the FDA 209E-2019 also provides guidelines for monitoring particles of larger sizes.

Permissible Size of Particulate Matter in the Current Era

As technology advances and our understanding of particulate contamination improves, the permissible size of particulate matter in the current era has been re-evaluated. The latest versions of ISO and FDA standards take into account these advancements and provide guidelines accordingly. In both sterile and non-sterile areas, the focus is on particles of size 0.1 μm or larger. However, it is important to note that smaller particles can also pose a risk, especially in sterile areas where the utmost cleanliness is required. Therefore, some facilities may choose to monitor and control particles of smaller sizes as well. It is worth mentioning that the permissible size of particulate matter may vary based on the specific requirements of the pharmaceutical product being manufactured or packaged. Some products may have more stringent cleanliness requirements, while others may have less stringent requirements.

Conclusion

Maintaining a clean and controlled environment in the sterile and non-sterile areas of pharma facility packaging and manufacturing is crucial for ensuring product quality and patient safety. The classification of filters used in these areas, as per ISO and FDA standards, helps in achieving the desired cleanliness levels. The latest versions of these standards, ISO 14644-1:2015 and FDA 209E-2019, provide guidelines for filter class and permissible size of particulate matter. It is important for pharmaceutical facilities to adhere to these standards and continuously monitor and control the particulate contamination levels to ensure the highest quality standards are met.

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