Importance Of Clean Room Particle Counting And Counting Devices
Particle Counting
What Is Particle?
If we evaluate the particle at the simplest level; let’s call it a particle. They are microscopic particles suspended in the air.
Why Is Particle So Important?
Particle in the environment; It causes the concentration of the product to deteriorate, its purity to change, its safety to decrease, its stability to deteriorate, and accordingly, “Loss of Money” and, most importantly, “Loss of Time” .
Particle in the environment is very important in the field of health, space science and electronic circuits, and it can cause irreversible errors.
What Are The Purpose And Rules Of Use In The Field Of Biotechnology And Pharmaceuticals?
To think simply;
- Our red blood cells are 5 µm in size,
- Our capillaries are between 5 and 10 µm in diameter,
- Our balls and arteries are 10-50 µm in diameter,
Accordingly, the rates are tabulated in ISO14644-1 and EU GMP Annex1 standards. In cases where these rates are above, the persons to be applied;
- increased risk of infection,
- Increasing allergic reactions
- It can cause negative effects such as embolism as a result of vascular occlusion.
| EC GMP | ISO | At Rest | In Operation | ||
|---|---|---|---|---|---|
| Grade | Class | 0,5 µm | 5.0 µm | 0,5 µm | 5.0 µm |
| A | 4.8 | 3,520 | 20 | 3,520 | 20 |
| B | 5 | 3,520 | 29 | 352,000 | 2,900 |
| C | 7 | 352,000 | 2,900 | 3,520,000 | 29,000 |
| D | 8 | 3,520,000 | 29,000 | not defined | not defined |
| ISO 14644-1:2015 CLASSIFICATION NUMBER (N) | MAXIMUM CONCENTRATION LIMITS (PARTICLES/M3) | |||||
|---|---|---|---|---|---|---|
| 0.1 µm | 0.2 µm | 0.3 µm | 0.5 µm | 1.0 µm | 5.0 µm | |
| ISO Class 1 | 10 | – | – | – | – | – |
| ISO Class 2 | 100 | 24 | 10 | – | – | – |
| ISO Class 3 | 1.000 | 237 | 102 | 35 | – | – |
| ISO Class 4 | 10.000 | 2.370 | 1.020 | 352 | 83 | – |
| ISO Class 5 | 100.000 | 23.700 | 10.200 | 3.520 | 820 | – |
| ISO Class 6 | 1.000.000 | 237.000 | 10.200 | 3.520 | 8.320 | 298 |
| ISO Class 7 | – | – | – | 352.000 | 83.200 | 2.930 |
| ISO Class 8 | – | – | – | 3.520.000 | 832.000 | 29.300 |
| ISO Class 9 | – | – | – | 35.200.000 | 8.320.000 | 293.000 |
To explain with an example; If you look through a window on a sunny day and see dust shimmering in the sunlight, you’ve demonstrated the theory behind a light scattering sensor or a particle counter. A sunbeam is like a laser, your eyes are like a photo detector, and if you organize and count particles in a stream separately, you become a particle counter.
Methods Used In Particle Counting
- Continuous particle measurement method (Continuous monitoring system); Continuous measuring devices used in this method are divided into two. With internal pump and external pump. Apart from these, for the environment; program to control and monitor, Alarm indicators, wiring. This method can be used for A and B classification.
- Sequential monitoring method (Sequential Monitoring); In this method, up to 32 points can be measured. C and D fields can be used for counting. It can be extended up to 30 m hose length. Particle counter, manifold (multiplier), tubing, and sampling points for this method
- Handheld and Portable particle measurement; They are devices used to take measurements at regular intervals in a clean area.
Working Principle Of Particle Counting Systems
Particle counting is done by light scattering method. Light-scattering sensors detect particles by scattering or reflecting light from the particle’s surface. B uses an advanced optical system to collect the scatter and focus it on the detector. When the particle passes through the light, it reflects the light to a curved reflector, the light scattered from this reflector is converted from photonic energy to electrical energy and counted according to the particle size.
Our Particle Measurement Systems Solutions
1) Continuous Meter with External Pump
Our Beckman Coulter MET ONE 6000 series device is used. Our device needs an external vacuum pump. This series is the industry leader. It is suitable in terms of cost compared to the internal pump system and can be used according to your SOP standards in terms of maintenance and sustainability. Calibration is done by removing the device from the clean area. We have options as 0.3 µm and 0.5 µm. With the LED light indicator on it, the device status can be seen instantly. Our devices have long-lasting laser diode equipment. Upon request, temperature and humidity sensors can be installed on the device. We have 0.1 CFM (2.83 lt/min) or 1.0 CFM (28.3 lt/min) air flow options for measurement in the area to be used. To communicate with the program; Analog 4-20mA, RS232, RS485 (ModBus RTU), Ethernet (TCP/IP) options are available. Complies with ISO 14644, FDA CGMP and EU GMP Annex1.
| MET ONE 6003 | MET ONE 6005 | MET ONE 60013 | MET ONE 60015 | |
|---|---|---|---|---|
| Flow Rate | 0.1 CFM | 0.1 CFM | 0.1 CFM | 0.1 CFM |
| Measuring Range | 0.3 m – 100 m | 0.5 m – 10 m | 0.3 m – 10 m | 0.5 m – 10 m |
| Standard Channel | 0.3 m ve 0.5 m | 0.5 m ve 5.0 m | 0.3 m ve 0.5 m | 0.5 m ve 5.0 m |
| Optional Channel | 0.3 ,0.5 ,1.0 ,5.0 µm | 0.5 ,1.0 ,5.0 ,10.0 µm | 0.3 ,0.5 ,1.0 ,5.0 µm | 0.5 ,1.0 ,5.0 ,10.0 µm |
| Source of light | Long Life Laser Diode | |||
| Exterior Material | 304 Stainless Steel | |||
| Status Indicator | Multi-Color LED Light Normal Status, Count Alarm, Count Alert, Sensor Problem, Flow or Connection Problem |
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| Vacuum Source | External Pump (minimum 40.6cm/Hg Vacuum) | |||
2) Continuous Meter with Built-in Pump
Our Beckman Coulter MET ONE 6015P device is used. It is the leader of the industry. It provides the vacuum required for measurement with its internal pump. The maintenance cost is very low, and maintenance and calibration are done in the field. In this way, calibration problems that may occur after transportation are minimized. There are 0.5 µm and 10.0 µm standard channel measurements. 1.0 CFM (28.3 lt/min) flow is provided by the internal pump. With the LED indicator on it, the device status is instantly observed. An optional external temperature and humidity sensor can be attached to the device. It is easy to integrate into the system and has Analog 4-20mA, RS232, RS485(ModBus RTU), Ethernet (TCP/IP) communication options. It meets 21 CFR Part 11, FDA cGMP and EU GMP Annex 1 standards.
| MET ONE 60015P | |
|---|---|
| Measuring Range | Standard 2 channels, Optional 4 channels |
| Source of light | Long Life Laser Diode |
| Vacuum Source | 1.0 CFM flow (28.3 lt/min) with Internal Pump |
| Exterior Material | 304 Stainless Steel |
| Signal Outputs | Analog 4-20 mA RS-232 RS-485(ModBus RTU) Ethernet (TCP/IP Protokol) |
| Status Indicator | Multicolor LED Normal Status, Count Alarm, Count Alert, Sensor Problem, Flow or Connection Problem |
You can view our product and request a presentation from the MET ONE 6000P Series Continuous Measurement Particle Device link.
3) Portable Particle Counters
It is used for routine environmental air particle counter in GMP and Clean Rooms. It allows users to directly upload the SOP sampling map and sampling configuration for each location to the system in routine counting. In this way, the points defined on the SOP can be mapped and ordered on the device. For these users and institutions; It helps to reduce training requirements and avoid missing data and errors.
A) MET ONE 3400+ Series
The new touch screen MET ONE 3400+ series helps you to download the SOP online, define the areas and take measurements in the defined areas sequentially with standard 6 channels. Fields and places to be measured within the fields can be defined in the device. Users can make measurements by entering their own user name and password, and get 21CFR part 11 compliant report output with e-signature.
| MET ONE 3413+ | MET ONE 3415+ | MET ONE 3423+ | MET ONE 3425+ | MET ONE 3445+ | |
|---|---|---|---|---|---|
| Standard Dimensions | 0.3, 0.5, 1.0, 3.0, 5.0, 10.0 µm | 0.5, 1.0, 2.0, 3.0, 5.0, 10.0 µm | 0.3, 0.5, 1.0, 3.0, 5.0, 10.0 µm | 0.5, 1.0, 2.0, 3.0, 5.0, 10.0 µm | 0.5, 1.0, 2.0, 3.0, 5.0, 10.0 µm |
| Flow Rate | 28.3 LPM (1.0 CFM) | 28.3 LPM (1.0 CFM) | 50 LPM (1.77 CFM) | 50 LPM (1.77 CFM) | 100 LPM (3.53 CFM) |
| Flow Rate Tolerance | ±5% | ||||
| Source of light | Long Life Laser Diode (10 years) | ||||
| Pump Types | Built-in, Filtered ISO3 standards | ||||
| Battery Type and Number | 1,2 or 3 Li Ion can be recharged. | 3 Li-Ion rechargeables. | |||
| Continuous Measurement Battery Runtime / 1 | 3 Moments | 3 Moments | 3 Moments | 3 Moments | – |
| Continuous Measurement Battery Runtime / 2 | 6.25 Moments | 6.25 Moments | 6.5 Moments | 6.5 Moments | 6 Moments |
| Continuous Measurement Battery Runtime / 3 | 9.25 Moments | 9.25 Moments | 9.75 Moments | 9.75 Moments | 5.5 Moments |
| Maximum Battery Charge Time | 3.5 hours (with 2 batteries) | 6.75 Hours (with 3 Batteries) | |||
| Dimensions | 26.7 cm(Width) x 26 cm(Height) x 21 cm(Depth) | ||||
| Weight(Without Battery) | 5.6 Kg | ||||
| Weight(With Battery) | 6.5 Kg (with 2 Batteries) | 6.9 Kg | |||
| Exterior Material | 316 Stainless Steel | ||||
| Screen | 10” High Definition LCD (1024×768) | ||||
| Display Sensitivity | High Sensitivity Touch Screen – Can work with Double Gloves | ||||
| alarms | Unlimited alarms per user-defined measuring channel or ambient sensor head | ||||
| Sampling Configuration | Sampling by time or volume up to 100 cycles with user-defined time intervals | ||||
| USB Output | 3 Adet USB Type A 2.0 | ||||
| USB Cihaz | 1 Adet USB Type B | ||||
| Ethernet | 1 802.3 Compatible 10/100 Base-TX Auto with MDI-X | ||||
| WiFi | 802.11 b/g 2.4 GHz WiFi Radio | ||||
| External Probe. | Probe for Relative Humidity and Temperature Sensor. | ||||
You can review our product and request a presentation from the Portable Air Particle Counters link.
B) MET ONE HHPC+ Series (Handheld Measurement)
Provides easy ISO Class 5 to 7 monitoring in hard-to-reach places. Lightweight with a high resolution display, these handheld meters are ideal for routine monitoring of controlled environments and mini-environments, easy filter leak troubleshooting for particulate contamination issues, spot control in critical areas, and targeting particle formation within process equipment. Easy network connection possibility, transfer via USB. ISO 14644-1 industry standards, 21 CFR Part11 standards, 0.3 µm – 10.0 µm particle measurement, 2 – 3 – 6 channel options, One hand operation
| Particle Size Range | Count Channels ISO 14644-1 (FS 209E) industry standards HHPC 6+ and HHPC 3+ (0.3µm version) – 0.3 µm – 10 µm HHPC 2+ and HHPC 3+ (0.5µm version) – 0.5 µm – 5 µm |
|---|---|
| Number of Channels | HHPC 6+ 1. Kanal 0.3 µm sabit diğer 5 kanal; 0.5µm, 1.0 µm, 2.0 µm, 5.0 µm, 10.0 µm HHPC 3+(0.3 µm) 1. Kanal 0.3 µm sabit diğer 2 kanal; 0.5µm, 1.0 µm, 2.0 µm, 5.0 µm, 10.0 µm HHPC 3+(0.5 µm) 1. Kanal 0.5 µm sabit diğer 2 kanal; 1.0 µm, 2.0 µm, 5.0 µm HHPC 2+ 1. Kanal 0.5 µm sabit diğer kanal 1.0 µm, 2.0 µm, 5.0 µm |
| Weight | 680 gr |
| Flow Rate | 2.83lpm. (Amount per minute for 0.3 µm in accordance with ISO 14644-1 class 5) |
| Connection | By Ethernet or USB cable. Or via USB disk |
| Screen | 3,5” high resolution (320×240) with selectable size and width font option |
| Data Screen | Creating trend graphs over particles and time |
| Exterior Material | Durable polycarbonate ABS |
| External Dimensions | 10.7” x 3.9” x 2.1” |
| Battery Usage Time | 10 hours of normal use, 5.5 hours of continuous measurement use |
| Battery Charge Time | 3.5 seconds |
| Data Memory | 10,000 records (5,000 when 21CFRpart11 security is enabled) |
| Count Efficiency | HHPC 3+ (0.3 µm) ve HHPC 6+ ; %50 @0.3 µm ve %100 > 0.45 µm (ISO 21501) HHPC 2+ ve HHPC 3+ (0.5 µm) ;%50 @0.5 µm ve %100 >0.75 µm (ISO 21501) |
| Reset Count | 1 count / 5 minutes (JIS B9921) |
| Concentration Limits | 4,000,000 / ft3 @ 10% loss of concentration HHPC 6+ , HHPC 3+(0.3 µm) 2,000,000 / ft3 @ 10% loss of concentration HHPC 2+ , HHPC 3+(0.5 µm) |
| Count Modes | Raw count , N/ft3 , N/m3 , N/L Cumulative or Differential mode |
| Security | Admin password control (optional) CFR 21 part 11 compliant Excel file |
| alarms | User-defined particle channel and limit |
| Operating temperature | 10°C to 40°C < 95% humidity |
| Storage Temperature | -10°C to 50°C < 98% humidity |
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