I. System Overview With the expansion of the influence of FDA and EU GMP in China and the launch of the new version of GMP in China, the dynamic monitoring of the clean area environment of pharmaceutical companies, especially the dynamic monitoring of suspended particles, has become a threshold that pharmaceutical companies must cross. Since the online monitoring system can simultaneously monitor particles, temperature and humidity, differential pressure, wind speed and other parameters for 24 hours, and can complete data storage, management and other functions, it is now also commonly used in...

1. Vacuum pump (need a backup) 7. Online biological air sampler 12. Sound and light alarm 2. Vacuum buffer tank 8. Online temperature and humidity sensor 13. Alarm control module 3. Air pump distribution control cabinet 9. Online differential pressure sensor 14. Spot displaying screen 4. R200 or R300 series particle sensor 10.Online wind speed sensor 5. R210 or R310 series particle sensor 16. Online ozone detector 6. 28.3L flow automatic controller (built-in micro flow rate regulator)

III、Decentralized sampling Type 1. R210 or R310 series particle sensor 2. Online temperature and humidity sensor 3. Online differential pressure sensor 4. Online wind speed sensor 5. Online ozone detector 6. Sound and light alarm 7. Alarm control module 8. R200 or R300 series particle sensor 9. Online biological air sampler 10. Spot displaying screen 11. Network hub 12. Online monitoring computer

IV、Wireless sampling Type 1 1. R210 or R310 series particle sensor 2. R200 or R300 series particle sensor 3. Online ozone detector 4. Online temperature and humidity sensor 5. Online differential pressure sensor 6. Online wind speed sensor 7. Sound and light alarm & control module 8. Wireless Signal Receiver 9. Online monitoring computer 10. Spot displaying screen 11. MES system

The design of the online monitoring system must first comply with the national standard GB 50073-2013 "Cleanroom Design Code" and the international standard ISO 14644-1:2015 "Air Cleanliness Classification" regarding sampling points. The new version of GMP also defines the monitoring requirements of clean environment. The frequency of monitoring and sampling volume for Class A areas should enable timely detection of all human interventions, episodic events and any system damage. This requirement excludes the use of sequential monitoring in these areas and the sampling must be continuous. Regarding...

Clean area (m2) is less than or equal to Minimum number of sampling points to be tested（NL） 1: 2015 Edition - Sampling points for the cleanroom area in at working surface height. The chart on the right shows ISO 14644- distributed throughout the entire area of the cleanroom and located standard also emphasizes that the sampling points should be evenly exceed the grade limits at a minimum 95% confidence level. The specifies that at least 90% of the cleanrooms or clean areas will not sampling points for each cleanroom or clean area to be graded and cleanroom area in question. Table 1 provides the...

China 2010 (GMP) cleanroom levels and monitoring requirements 2010 GMP Cleanroom levels： 1) The design of clean areas must meet the appropriate cleanliness requirements, including meeting the "static" and "dynamic" standards. Cleanroom Level Maximum allowable number of suspended particles/m3 Risk operation area, such as exposure machine in the loading and unloading port; coating photoresist equipment loading port; after the development of the unloading port, etc. To confirm the level of Class A clean area, the sampling volume of each sampling point should not be less than 1 m³. The level of airborne...

China 2010 (GMP) cleanroom levels and monitoring requirements 3) Dynamic monitoring of suspended particles in the clean area should be carried out according to the following requirements：  Based on the results of the cleanliness level and air purification system confirmation and risk assessment, determine the location of sampling points and conduct daily dynamic monitoring.  Suspended particle monitoring should be performed in the Class A clean zone during the entire process of critical operations, including equipment assembly operations. When contamination during production may damage the...

Particle sensor, biological sensor, temperature and humidity, differential pressure, wind speed and other sensors can form a separate LAN or be connected to the user's internal LAN 24-hour continuous realtime monitoring Complete event log. 1.The working status of the system 2. The working status of the sensors 3. all operations of the logged-in user (change of parameters, data query, data export, etc.) 4. All alarm events Software users are divided into 3 levels of administrative rights: administrator, engineer and operator Two sets of vacuum pump systems are adopted, one for backup and one for...

R series airborne particle counter The R series dust particle sensors can be installed with one or more monitoring points according to the actual site conditions, and the measured data will be displayed directly on the display of each monitoring point. The R series dust particle sensors can monitor particles of 0.3μm, 0.5um and 5.0um and meet the requirements of GMP, FDA and ISO21501-4, etc. Customers can choose the model that suits their needs.  Reasonable structure design, compact size, easy installation Particle size channel: 0.3um-25um selectable Sampling flow rate: 1CFM (28.3LPM) or 0.1CFM...

R series sensor Item： Display： Communication： Power supply： Pumped type： External pump N：without display D：2.4 inch OLED display D：2.4 inch OLED display R：RS485(modbus T：TCPIP(modbus) I： 4-20mA current output（2 channels） V： 0-5V voltage output（2 channels） E： relay output（2 channels） W：WiFi L：LORA 12-24V（RS485（modbus）12-24V、48V POE（TCPIP（modbus)） internal pump（R210） external pump（R310） 0.9Kg 135×120×60（mm）

Sampling flow rate: 28.3L/mim, 50L/min, 100L/min Sampling head volume: ￠100×50mm Sampling head material: 316L stainless steel Sampling head weight: 1.6Kg With field start/stop control switch Working environment: temperature: 0-50 ℃, humidity: <85% RH Real-time recording of sampling volume, sampling date, sampling time and other key parameters of each sampling point Easy to replace the cuvettes, take down the collection port can replace the cuvettes (using standard general cuvettes diameter ￠ 90 × 15)