Top 5 Reasons You Should Hire a Particle Counter

Maintaining appropriate levels of cleanliness is a top priority for cleanroom operators. Particle counters are an essential tool within controlled environments as they monitor airborne particulates, allowing you to validate your cleanroom equipment and processes. 

Regular cleanroom monitoring using a particle counter is the only way to evidence a facility is consistently meeting air quality parameters set by industry regulations. From handheld particle counters to remote options, cleanrooms should include routine air monitoring to verify their operations are performing optimally. 

However, some of the barriers to regular particulate monitoring, especially for smaller businesses, are limited budgets and the lack of access to specialist equipment including particle counters. In this blog, we’ll explore the benefits of hiring particle counter equipment and how you can choose the right options for your cleanroom. 

Particle counters are a piece of equipment used within a controlled environment under both ‘at rest’ and ‘in operation’ conditions. This is performed to identify and quantify the level of airborne particles, validating the cleanroom against industry standards including ISO 14644 and GMP. 

As the only guaranteed method of recording and evidencing accurate air cleanliness levels, particle counters are widely used by a range of cleanroom environments and industries, including pharmaceuticals, electronics and semiconductors, research and development, and injection moulding.

Particle counters display readings in two columns: differential (depicted by ∆ delta) and cumulative (depicted by ∑ sigma). The differential reading shows the number of particles within a specific, defined size range, and the cumulative reading shows the number of particles from a minimum size, upwards. 

ISO 14644 and GMP standards define acceptable airborne particle levels in order to achieve a certain classification or grade, with maximum allowable concentrations of particles per m³. However, regardless of ISO classification or GMP grade, all cleanrooms should implement the appropriate tools and procedures to effectively reduce contaminations and maintain acceptable particle levels.

a All concentrations in the table are cumulative, e.g., for ISO class 5, the 10,200 particles shown at 0.3µm include all particles equal to and greater than this size. 
b These concentrations will lead to air sample volumes for classification. Sequential sampling procedure may be applied.
c Concentration limits are not applicable in this region of the table due to very high particle concentration.
d Sampling and statistical limitations for particles in low concentrations make classification inappropriate.
e Sample collection limitations for both particles in low concentrations and sizes greater than 1µm make classification at this particle size inappropriate, due to potential losses in the sampling system.
f In order to specify at this particle size in association with ISO class 5, the macroparticle descriptor M may be adapted and used in conjunction with at least one other particle size.
g This class is only applicable for the in-operation state.

a) For grade D, in operation limits are not predetermined. The manufacturer should establish in operation limits based on a risk assessment and on routine data, where applicable.

By hiring a particle counter, you’ll eliminate the upfront cost and investment required to purchase these specialised instruments, ideal for small businesses, universities, and start-ups. Opting for this approach will allow you to allocate resources and budget in other areas, especially for short-term projects or infrequent monitoring needs. 

Hiring a particle counter provides flexibility to scale up and adapt based on your project’s demands. Whether you need additional units for a larger validation or a specific model for a unique application, hiring a particle counter can quickly accommodate your cleanroom’s evolving needs. 

By hiring a particle counter, you’ll receive expert support and guidance to ensure your team can effectively operate the particle counter equipment and interpret the data, enhancing your overall monitoring capabilities and maintaining compliance with regulatory standards.

Rental particle counters will arrive pre-calibrated, allowing you to promptly monitor your cleanroom’s air quality, whilst providing you with reassurance that you’re getting accurate results. 

Particle counters are an effective way to detect contamination incidents early and get real-time results on changes in particle levels, mitigating the risk of cleanroom downtime. Hiring a particle counter provides you with a rapid solution to identifying malfunctions or errors in your cleanroom processes of equipment. 

Particle counters are essential for routine environmental monitoring, during cleanroom validation, or following a contamination incident to identify the root cause. There are several particle counter options to choose from depending on your cleanroom’s requirements and classification. 

• Portable Laser Particle Counter: A handheld device that identifies and quantifies particles via a laser beam passing through the air or liquid sample.
• Handheld Particle Counter: A portable, handheld device that measures the number and size of airborne particles in a specific location. 
• Remote Particle Counter: A stationary device that continuously measures the number and size of airborne particles, transmitting the results to a separate data collection platform.

GMP (particularly grades A) mandates continuous monitoring of airborne particles during operations using a portable laser particle counter, with a minimum flow rate of 28.3L/min. Under ISO, handheld or remote particle counters are a requirement during the validation and revalidation processes; however, it’s best practice to routinely monitor airborne particles to ensure your cleanroom remains compliant and operational.