Cleanroom Particle Counters
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 pharmaceutical production of medicinal products.
For questions regarding sample volume, recommended flow rate, and sample frequency we recommend using our online tool - Click Here
Standards and Particle Sizes of Interest
In compliance with the PIC/S Guide to Good Manufacturing Practices For Medicinal Products (Part 1) and the EU GMP Annex 1 standards, most medicinal product manufacturers are concerned with the >0.5 µm and >5.0 µm channels for routine monitoring.
At 1 CFM (28.3168 LPM), it takes 35.3 minutes to sample a full cubic meter, which may be a significant demand on human resources. Between 2005-2007, 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 biopharmaceutical producers.
GRADE A (ISO 5) : Grade A zones are high risk / critical areas that generally use aseptic processes, have laminar flow, and are monitored "In Operation" at 1 CFM continuously during the duration of the critical process. Continuous particulate monitoring is required, and frequent viable monitoring is also required (EU GMP, Annex 1; PIC/S, and WHO Annex 4). 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.
GRADE B (ISO 5) : Grade B areas are generally defined as Grade A support areas. It is industry best practice among biopharmaceutical producers to do full cubic meter sampling in Grade B areas. The frequency per U.S. FDA Aseptic Processing Guide, USP <1116>, and JP XVI is "Each operating shift." For EU GMP Annex 1, PIC/S and WHO Annex 4 , "In operation, frequent particle monitoring is required." Japan Aseptic Processing Guidance, "Each operating shift for airborne micro, surfaces and personnel; continuous particulate monitoring." (Ref. PDA Technical Report #13, page 9) As a result, most life science producers are doing sequential monitoring with a portable particle counter at 75 or 100 LPM flow rate. However, depending on the risk assessment, continuous monitoring may be required, and we would normally recommend one of Climet's CI-3100 models. When aseptic monitoring is required, we recommend our pharmaceutical and industrial grade microbial air samplers.
GRADE C & D (ISO 7 & 8): These areas will require sequential routine monitoring, generally with a minimum sample volume of at least 2 liters AND sample time of at least 1 minute per ISO 14644-1/2:2015. In these circumstances, generally a 1 CFM (28.3 LPM) or 50 LPM portable particle counter is recommended. However, on many occasions, generally to eliminate sample averaging requirements, we have seen full cubic meter sampling in Grade C & D areas, which in this case a higher flow rate of 100 LPM portable particle counter would be recommended. Climet recommends a 1 minute sample with a 100 LPM flow rate. The higher single sample volume of 100 liters may eliminate the need to take three low volume samples (at 28.3 liters x3) plus averaging calculations (Refer to your risk assessment). The frequency of routine monitoring would depend on the risk assessment according to EU GMP, Annex 1; PIC/S; and WHO, Annex 4. Guidance is provided in: (1) Japan Aseptic Processing Guide, which states, "Airborne viable monitoring twice per week, and airborne particulate once per month;" (2) JP XVI requires monitoring once per week; and (3) USP <1116> recommends each operating shift for ISO Class 7 (Grade C areas), and twice per week for ISO Class 8 (Grade D areas).
High Pressure Gases? For monitoring high pressure gases, an autoclavable high pressure diffuser is required.
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, 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 your application, and would welcome an opportunity to answer any further questions. Please, feel free to contact us anytime!