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Is the safyr OPC solution applicable to all cleanroom sectors ?
In the field of clean rooms and associated controlled environments, in addition to initial qualification or periodic qualification, monitoring the performance of installations has become essential. This is because surveillance provides a flow of real-time data, offering a more detailed and, above all, more accurate view of the behavior and performance of assets. Clean room monitoring offers many advantages:
- Faster response to undesirable events and conditions
- Ability to develop trends over time based on recorded data
- Integration of data from multiple instruments
- Better knowledge of the installation and process, for more effective risk analysis
- Better control of operating costs and product losses.
Meeting regulatory requirements
In the pharmaceutical sector, in August 2022, Annex 1 of the GMP/BPF on good manufacturing practices for medicinal products for human use was revised. This approach is an integral part of a contamination control strategy that must be implemented throughout your facility. In the hospital sector, more and more departments are subject to regulatory requirements (IVF/PMA, human tissue banks, hospital pharmacies, cell therapies, etc.).
In the field of clean rooms and associated controlled environments, in addition to initial qualification or periodic qualification, monitoring the performance of installations has become essential. This is because surveillance provides a flow of real-time data, offering a more detailed and, above all, more accurate view of the behavior and performance of assets. Clean room monitoring offers many advantages:
- Faster response to undesirable events and conditions
- Ability to develop trends over time based on recorded data
- Integration of data from multiple instruments
- Better knowledge of the installation and process, for more effective risk analysis
- Better control of operating costs and product losses.
Currently, the market for particle monitoring solutions is very exclusive and mainly targets the industrial pharmaceutical sector, which is subject to GMP/BPF certification and has the ability and obligation to allocate a significant budget (research, purchase, installation, qualification, maintenance, calibration, repair, etc.).
Once again, for cost reasons, monitoring is generally limited to Class A environments (requirements in Annex 1). It is recommended that similar systems with a reduced sampling frequency be used only in Class B rooms.
The main objective of the safyr OPC solution is to democratize continuous particle monitoring and make it accessible to a wide range of users, industries, and applications, thereby improving control of particle contamination risk across all sectors.
That is why safyr has taken particular care in developing this solution, meeting all clean room requirements (materials, design, size, HEPA filtration, H2O2 resistance, etc.) and making it flexible and easy to use (wireless operation, battery and/or mains power, built-in accelerometer, etc.).
Monitoring data is accessible in real time via the Lyra software or can be used by integrators who already have a monitoring software solution.
That is why safyr has taken particular care in developing this solution, meeting all clean room requirements (materials, design, size, HEPA filtration, H2O2 resistance, etc.) and making it flexible and easy to use (wireless operation, battery and/or mains power, built-in accelerometer, etc.).
Monitoring data is accessible in real time via the Lyra software or can be used by integrators who already have a monitoring software solution.
safyr OPC has also been designed to comply with the requirements of ISO 21501-4. From a metrological point of view, comparative studies with other measuring instruments dedicated to clean room qualification have shown that safyr OPC easily meets industry requirements.
From a purely technical standpoint, safyr OPC has been carefully designed to meet monitoring objectives.
Our safyr OPC solution has also enabled users to familiarize themselves with the actual performance of their installations when in operation. This data is not currently accessible using traditional monitoring methods (differential pressure, temperature, humidity, speed, etc.).
Our safyr OPC solution has also enabled users to familiarize themselves with the actual performance of their installations when in operation. This data is not currently accessible using traditional monitoring methods (differential pressure, temperature, humidity, speed, etc.).
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