how to find particle sizes in class 100 cleanroom
A cleanroom is a controlled environment where the particles are regulated to reduce contamination. The class of a cleanroom determines the maximum number of allowed particles of a given size. Cleanrooms can vary from Class 1 to Class 10,000. A cleanroom with a Class 100 rating is the most stringent, allowing only 100 particles per cubic foot. It is crucial to monitor the particle sizes regularly to prevent contamination and ensure the cleanroom's compliance with the Class 100 standard.
Here are some steps on how to find particle sizes in a Class 100 pharma clean room.
Understanding Particle Size
Before we dive into the process of finding particle sizes in a cleanroom, it is essential to understand the size of the particles we are looking for. Particles in cleanrooms are measured in micrometers (m). A micrometer, also known as a micron, is one-millionth of a meter or one-thousandth of a millimeter. Contaminants in cleanrooms are divided into two types: viable (microorganisms) and non-viable (particles). Non-viable particles may vary in size, ranging from 0.1 to 10 m.
Selecting The Particle Counter Instrument
A particle counter is a device used to measure the number and size distribution of particles in the air. It works by drawing air into a chamber, where the particles are detected and counted. The selection of particle counter instruments depends on the particle size range, air volume, environmental conditions, and other factors. In a Class 100 cleanroom, a handheld laser particle counter is typically used to measure particle sizes of a range between 0.3 m to 10 m and airflow velocity measuring units are applied to determine volume of airflow.
Sampling Plan Establishment
A sampling plan is a well-structured approach to collect representative data from a specific area within the cleanroom. It is essential to ensure accurate and reliable measurement of particle sizes. A sampling plan should include the following aspects: the location of sampling points, the sampling time, the sampling frequency, the sampling duration, and the number of samples. Sampling points should be selected based on the risk assessment and criticality analysis of the cleanroom's process.
Sampling Procedure Execution
Once the sampling plan has been established, the actual sampling procedure must be executed. Before taking any particle measurements, the particle counter must be calibrated according to the manufacturer's instructions. The next step is to select the sampling point and hold the particle counter at the designated location. The particle counter should run for the designated sampling time and record the data. Repeat this process until all the sampling points have been measured.
Data Analysis and Management
After executing the sampling procedure, the data should be analyzed and organized to generate a particle count report. The data analysis will show the particle sizes, particle count, and other necessary information. The report should be accessible by the cleanroom management, and any deviations from the Class 100 standard should be addressed immediately.
Conclusion
The process of finding particle sizes in a Class 100 cleanroom is crucial to maintain compliance with the standard and prevent contamination from non-viable particles. It is vital to follow the above steps to ensure accurate and reliable measurement of particle sizes. A cleanroom is only efficient if it is well-maintained, and particle size monitoring is an essential aspect of maintaining a cleanroom.
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