Which Particle Counter?

Which Particle Counter?

Which Particle Counter Is Right For You?

Climet offers a large variety of particle counters, each differentiated by flow rate, and other features.

This article specifically addresses the life science industry, and in particular biopharmaceutical production of medicinal products.

Standards and Particle Sizes of Interest

In compliance with the 2017 PIC/S Guide to Good Manufacturing Practices For Medicinal Products (Part 1) and the 2008 EU GMP Annex 1 standards, most medicinal product manufacturers are concerned with the  >0.5 µm and >5.0 µm channels.

At 1 CFM (28.3 LPM), it takes 35.3 minutes to sample a cubic meter, which may be a significant demand on human resources. Climet pioneered higher flow rates in response to this problem, being the first to introduce instruments with 50 LPM,  then 75 LPM, and ultimately 100 LPM flow rates.

What is the optimal flow rate for my sample area?

The following are guidelines for red biotechnology or pharmaceutical producers.

GRADE A: Grade A zones (ISO Class 4.8) are high risk / critical areas that generally use aseptic processes, have laminar flow, and are monitored continuously (i.e., during the duration of the critical process) at 1 CFM. In these applications, one of our CI-3100 models would be recommended with a facility monitoring solution.  Per the above standards, full cubic meter sampling is required in Grade A areas when manufacturing medicinal products.  When aseptic monitoring is required, we recommend our pharmaceutical grade microbial air samplers.  For monitoring high pressure gases, an autoclavablehigh pressure diffuseris recommended.

GRADE B: It is industry best practice among biopharmaceutical producers to do full cubic meter sampling in Grade B areas (ISO Class 5). The frequency of monitoring Class B areas may be reduced in some cases.  If your risk assessment allows for sequential monitoring, then a high flow rate portable particle counter is generally recommended. A 75 LPM portable particle counter will take 13.3 minutes to sample a full cubic meter, and a 100 LPM portable particle counter will take 10 minutes to compete a full cubic meter sample. Otherwise, when continuous monitoring is required, one of Climet's CI-3100 models would be recommended.

GRADE C & D: ISO Class 7-8 areas respectively, will require sequential routine monitoring, generally with a sample volume of at least 2 liters AND sample time of at least 1 minute. In these circumstances, a 1 CFM (28.3 LPM) or 50 LPM portable particle counter is recommended. In either case, a 1 minute sample would generally be taken. On rare occasions we have seen full cubic meter sampling in Grade C & D areas, which in this case a higher flow rate of 75 LPM or 100 LPM would be recommended.

Higher flow rates are generally accompanied by a nominally higher price, which is usually more than offset by the reduction in labor expenses due to less time spent sampling. Therefore, a contributing factor for determining the appropriate flow rate may be the size of your production facility and number of sample points.

What type of data interface do I need?

Climet offers a variety of data interfaces from Serial Data, Ethernet, Wi-Fi, USB, PDF (Portable Document Format) and 4-20 mA. Our portable particle counters also have a built-in printer.

For more information about compatibility with 3rd Party LIMS providers, Click Here.  Otherwise, learn about Climet Facility Monitoring Solutions by Clicking Here

We would be happy to recommend an appropriate solution for you application, and would welcome an opportunity to answer any further questions.  Please, feel free to contact us anytime!