Clean Areas in Pharmaceutical Manufacturing
Clean areas play a significant role in production processes in the pharmaceutical industry. A clean area is defined as a specific area where the presence of pollutants (including physical, chemical, and biological particles) has been eliminated or kept to a bare minimum. Such areas usually contain costly materials and equipment that collect and harbor impurities.
Types of Clean Areas
Clean areas come in different classes, which are based on the degree of contamination control needed for specific manufacturing processes. The Federal Drug Administration (FDA) has established three levels of cleanliness for these spaces. They are classified as follows:
Class 100 – also known as ISO 5 – is the most stringent level of cleanliness and requires particulate counts to be below 100 particles per cubic foot. This level is often used when working with extremely sensitive materials or components such as those used in sterile drug production.
Class 10,000 – also known as ISO 7 – requires particulate counts to be below 10,000 particles per cubic foot. This level is sufficient for many general manufacturing processes, such as packaging or tablet coating operations.
Class 100,000 – also known as ISO 8 – requires particulate counts to be below 100,000 particles per cubic foot. This level is suitable for processes where less sensitive materials are being handled, such as mixing or weighing operations.
In addition to the particulate count requirements outlined above, there are other considerations when creating a controlled environment, such as temperature and humidity control, airflow patterns, and pressure differentials between rooms or zones within the same area. It’s important to note that all of these variables must be taken into account when establishing a quality system designed specifically for your facility’s needs.
Clean areas play an integral role in pharmaceutical manufacturing by providing a safe and controlled environment for workers to handle sensitive materials and equipment without fear of contamination from outside sources. Awareness of the specifications demanded by each clean area can help you establish a high-end quality system corresponding to the requirements of your organization as well as ensure that you comply with relevant safety and effectiveness standards. If you use appropriate procedures, you will be sure that your products conform to all safety and legal standards, therefore performing production operations as smoothly as possible. It is a good idea to invest in a properly constructed and optimized clean room since this may save you much money and effort in the future (due to the absence of possible damage).