Application of KANOMAX Dust Particle Online Monitoring System EP-CRMS

Application of KANOMAX Dust Particle Online Monitoring System EP-CRMS

Simultaneously monitoring particles, wind speed, temperature and humidity, differential pressure, planktonic bacteria, etc. in accordance with the relevant requirements of 21 CFR Part 11, data upper limits can be set to achieve flexible selection of sound and light warning and alarm functions. Real time monitoring system software can run on local area networks for the highest risk points such as filling machines, freeze-drying machines, high-temperature sterilization, and background areas. With authorization, functions and data can be set and viewed, providing services such as maximum risk point assessment and confirmation, scheme design, installation and construction, certification document production, and training

System Introduction

The clean room environment dynamic online monitoring system is a multi-point real-time testing and centralized data processing monitoring system that can dynamically monitor the number of dust particles, floating bacterial colonies, and environmental parameters (wind speed, temperature and humidity, pressure difference, noise, illumination, etc.) in various high-risk key areas during the production process, ensuring the safety, effectiveness, and controllability of the production process. It has functions such as real-time monitoring, data alarm, data review, audit tracking, electronic signature, system verification, data caching, intelligent maintenance, data backup, printing, etc.

Sensors: dust particle counting sensor, planktonic bacteria sampler, wind speed sensor, temperature and humidity sensor, pressure difference sensor .. . ..
Controller: line collection controller, particle sampling controller, planktonic bacteria sampling controller, alarm controller
Gas source: Vacuum gas source system
Monitoring: servers, monitoring computers, tablets, database software, system software
Verification: 4Q, FAT, risk assessment
Components: equal power sampling head, electronic control system, inner film sampling tube, gas source pipeline, installation bracket


Dust particle counting sensor

Adopting a long-life laser light source, with an average operating time of over 10 years and a 3-year ultra long quality guarantee;
3718/3719 has a cache function for 2000 sets of test data, ensuring that monitoring data is not lost and has traceability;
It has the function of resisting VHP, alcohol vapor, etc;
It has ModBus RTU/TCP communication protocol and can be compatible with other systems.

Wind speed, temperature and humidity, pressure difference sensors

Floating bacteria sampler
Meet the requirements of ISO 14698-1 and ISO 14698-1 Annex B;
Sampling flow rate (28.3L/min or 50L/min);
The sampling controller monitors in real-time and ensures that it reaches 1 meter3Sampling quantity;
The test results need to be cultivated and analyzed;

Sampling controller
Control the on/off of the gas source system;
The sampling controller monitors in real-time and ensures that it reaches 1m3Sampling quantity;
Control the opening or closing of sound and light alarms and equipment linkage;

Flexible selection of multiple testing parameters
Real time monitoring of the number of dust particles, floating bacterial colonies, and environmental parameters (wind speed, temperature and humidity, pressure difference, noise, illumination, etc.);

Professional settings, intelligent data statistics
Setting up personnel operation permissions, addresses, actions, and limits (alert, action, alarm) for each sensor;
Real time display and recording of data (cumulative, UCL, minimum, average, maximum) in the form of lists, curves, columns, etc;
Generate daily, weekly, monthly, and annual reports of data, conduct periodic reviews and historical comparative analysis, backup, output and print in EXCEL or PDF format;

Dual flow control, real-time monitoring of sampling volume
The particle counting sensor and planktonic bacteria sampler are equipped with sampling controllers to enable the opening or closing of the gas path and real-time monitoring of the sampling volume up to 1m3；

intelligentcall the police
When the sensor is abnormal (mechanical failure, data deviation, false counting, flow abnormality, signal failure, etc.), real-time sound and light alarm;
The system has multiple options for alarm reasons, which can be selected as comments or manually entered;

Smart Linkage
When data is abnormal, the system software can be used to pause and reset equipment such as filling machines and gas supply systems;

multi-levelpowerRestricted management
Authorize administrators, operators, process technicians, IT or QA personnel to operate monitoring systems or access data;

Audit tracking, electronic signature
Record information such as account creation, personnel login, permission changes, system running time and parameter changes, data, alarms, etc;
Data can be reviewed, saved, backed up, archived, and printed, and confirmed by relevant authorized personnel one by one or in batches, achieving electronic signatures;

Intelligent reminder maintenance
The system is based on the raw information of sensors and intelligently reminds the sensor of the calibration and maintenance dates, reducing labor costs;

data caching
Sensors have data caching function to avoid data loss caused by abnormal reasons such as power outages, and have traceability;

The gas source system operates reliably
Adopting a dual pump redundant vacuum system, two dry oil-free rotary vane vacuum pumps, one for backup and one for use, can switch between manual or automatic operation;

Convenient expansion of monitoring points
Testing points for parameters such as dust particles and planktonic bacteria can be added according to actual needs, making expansion convenient and easy to operate;

Strictly follow relevant standards
Meet the requirements of FDA and CRF Part 11, EU-GMP, GMP 2010, GB/T 16292-16293 and other standards;

Professional installation components
The power sampling head and installation components are made of 316 stainless steel, equipped with an inner film purification sampling tube, and the installation components comply with the requirements of GB 50591-2010 standard.

Participating standards

The company participated in the drafting of standards such as "Performance Test Methods for Dust Particle Counter GB/T 6167-2007", "Calibration Specification for Dust Particle Counter JJF 1190-2019", "Calibration Specification for Online Dust Particle Counter", "Calibration Specification for Aerosol Spectrophotometer JJF 1800-2010", and "Calibration Specification for Thermal Anemometer".

The company develops and produces products withTechnical calibration equipment, such as wind speed correction wind tunnel, standard particle generation device, temperature and humidity calibration device, dust calibration device, aerosol photometer calibration device, and air volume hood calibration device. Nearly a hundred metrology research institutes or third-party metrology and testing units in the vast majority of provinces and cities across the country have been equipped with kanomax dust particle calibration devices for the verification and calibration of dust particle counters and other products.

Application of KANOMAX Dust Particle Online Monitoring System EP-CRMS