LASENSOR specializes in laser detection technology to provide accurate, efficient, and real-time measurement and diagnostic instruments. The company offers two main products with full intellectual property rights: laser bioaerosol monitoring and identification systems, and automated medical testing instruments. Additionally, LASENSOR provides design and manufacturing services for optical measurement instruments, detection systems, and lenses.
How to Choose the Right Dust Particle Counter?
Dust Air Laser particle counters are widely used in industries such as pharmaceuticals, electronics, machinery, and microbiology. They are employed to monitor and test the purification effects and cleanliness levels of various clean workbenches, laboratories, cleanrooms, and clean workshops to ensure product quality. This article will first introduce the testing basis and standard specifications for suspended particles in cleanrooms, and then guide you in selecting an appropriate dust particle counter.
1-The air cleanliness levels in pharmaceutical industrial cleanrooms are specified in GMP (2010) as four grades: A, B, C, and D. So, what are the criteria for classifying pharmaceutical clean areas into Grades A, B, C, and D?• Grade A: High-risk operation areas Examples include filling areas, areas where rubber stoppers are placed, open ampoules, open vials, and areas for sterile assembly or connection operations. These areas are typically maintained by unidirectional airflow workstations (hoods). The airflow in the working area of the unidirectional airflow system must be uniform, with a velocity of 0.36-0.54 m/s (guideline value). There must be data to prove the unidirectional airflow status and it must be validated. In closed isolators or glove boxes, unidirectional airflow or lower airflow velocity can be used.• Grade B: Background area for high-risk operations in Grade A zones This refers to the background area for sterile compounding and filling operations in Grade A zones.• Grade C and D: Clean operation areas with lower importance in the production of sterile drugs
In summary, Grades A and B are equivalent to Class 100 clean areas, with Grade A having stricter requirements and a higher background environment. Grade C is equivalent to a Class 10,000 clean area, and Grade D is equivalent to a Class 100,000 clean area. (The cleanliness of cleanrooms is measured by the number of dust particles with a diameter greater than or equal to 0.5 um per cubic meter of air.)
2- What are the occupancy states for cleanroom classification?
The classification of cleanrooms or clean areas based on airborne particle concentrations should be specified under one or more of the following occupancy states: "as-built," "at-rest," and "operational."• As-built: The cleanroom or clean area is equipped with all service facilities and is ready for use, but there are no equipment, furniture, materials, or personnel present.• At-rest: The cleanroom or clean area is fully constructed and equipped, operating in the agreed manner, but without personnel present.• Operational: The cleanroom or clean area is operating in the agreed manner with a specified number of personnel working in the agreed manner.
03 What are the industry standards for clean environment classification?
When testing Grade B and Grade A areas,
the minimum sampling volume is 1,000L. If the sampling rate is 2.83L/min, the sampling time required for each test would be 350 minutes, which is excessively long. However, if a detection instrument with a higher sampling rate of 28.3L/min is chosen, the sampling time for each test would be reduced to only 35 minutes.
Therefore, for small-sized Grade B and Grade A clean areas with few sampling points, a dust particle counter with a sampling rate of 28.3L/min is sufficient to meet the requirements.For Grade A and Grade B areas with large sizes and numerous sampling points, considering the time required to complete a comprehensive test, it is advisable to use detection instruments with even higher sampling rates. Dust particle counters with sampling rates of 50L/min or 100L/min would be appropriate to meet the requirements in such cases.
When testing Grade C and Grade D areas,
the minimum sampling volume required is greater than 6.9L. If the sampling rate is 2.83L/min, the sampling time for each test would not exceed 3 minutes. In this case, a dust particle counter with a sampling rate of 2.83L/min is sufficient to meet the requirements.
