With the expansion of the influence of FDA and EU GMP in China and the launch of the latest version of GMP in China, dynamic monitoring of particles in key areas of high-risk drug production has become a threshold that pharmaceutical companies must cross. In this context, the online monitoring system for dust particles has also been increasingly valued by pharmaceutical companies. The online monitoring system for dust particles installs multiple remote particle sensors at various key sampling points in the workshop, samples and calculates the air in the monitoring area through sensors, and transmits the monitoring results to the control computer. Then, professional pharmaceutical monitoring software that complies with 21CFR PART11 can be used to achieve the dynamic monitoring effect of dust particles. Environmental parameters such as floating bacteria sampling, pressure difference, temperature and humidity, and wind speed can be included in this monitoring system to form dynamic environmental monitoring of the entire aseptic production process, which complies with the relevant regulations of the US FDA, European GMP, and the new version of China's GMP for aseptic production, and provides reliable data support for pharmaceutical companies to obtain FDA and EU GMP certification.

Original imported particle counter, monitoring particle size 0.5μm, 5.0μm, flow rate 28.3L/min
Special software for the pharmaceutical industry, in compliance with GMP, ISO14644, and FDA standards.
Well-known brand vacuum pump, dual pump redundant switching control, one for backup and one for use
Loop pipeline laying to ensure uniform gas volume
Special stainless steel material for clean rooms
Compatible with temperature and humidity, pressure difference, wind speed and other monitoring
Real-time data monitoring, historical data storage and export
Historical data trend analysis, export, printing
On-site sound and light alarm
Audit tracking function
Electronic signature
Remote display control of particles and floating bacteria
With expansion capabilities
Multi-level authority management
Verification file

Features of dust particle online monitoring system:

Reduce labor costs, avoid factors such as manual inspection and interference with the clean room environment;
Meet the requirements for obtaining continuous production data, so that the entire production process can be monitored in real time:
The monitoring points are fixed in time and space, and the particle count quality is high, meeting the requirements for accurate data;
The data monitored at the same sampling points are comparable and referenceable. Continuous monitoring will establish a typical monitoring baseline in the production process. Based on this baseline, the alarm limit and movement limit can be determined based on experience, providing sufficient data for finding the root cause of changes in the production environment as required by GMP.
 

The clean areas required for sterile pharmaceutical production can be divided into the following four levels:

Class A:High-risk operation areas, such as filling areas, stopper placement areas, container opening areas, and areas for aseptic assembly or connection operations. Laminar flow operating tables (hoods) are usually used to maintain the environmental conditions of the area:
Class B:Refers to the background area where high-risk operations such as aseptic configuration and filling are located in Class A areas:
Class C and Class D:Refer to the less important clean operation areas in the production of sterile drugs.