Setting up an EMS in the field of radiotherapy
54
differential
pressure sensors
38
temperature sensors
20
sensors
relative humidity
Thanks to its experience in cleanroom qualifications, the HeX + safyr. group was able to respond to the specific problems of this project and provide pragmatic solutions for our customer Telix.
"Our response immediately appealed to both the end customer and the design office in charge of the project. As the world of cleanrooms is fairly small, the customer knows how rigorous we are when it comes to qualifying cleanrooms. So it was in a very good climate of mutual trust that the project got under way".
Installation
Radiotherapy requires specific infrastructures. We therefore worked in two parts
1 / PRODUCTION
To ensure proper data transmission, the production section, which is difficult to access because of lead walls, is equipped with wired sensors with Modbus communication.
2/ LABORATORY QC-R&D
The QC and R&D laboratory is equipped with wireless probes for greater flexibility in equipment monitoring.
On a TECHNICAL level
The various data feeds have been physically divided into two specific cabinets.
These cabinets are pre-wired at the factory and pre-equipped with pressure probes in order to optimise the final installation time on site.
In the event of a gateway crash, each cabinet can take over and the instruments are on a back-up power supply. In addition, each of the cabinets is equipped with a 4G router and a small UPS.
"If there is a network outage, the customer and our technical department are instantly informed via alarms. The router can be switched on at the click of a button, so there's no loss of data feedback."
"What's more, each gateway has the capacity to store a week's worth of data, which is reassuring in terms of service continuity."
Installation and data upload to the software in just 4 days
The plus
An additional light signal, placed above each door, indicates whether or not it is safe to enter the room. This light signal is controlled by the differential pressure feedback. In addition to the simple interloc, the operator must also check that the pressure is correct using this simple light signal.
"We manage to respond to this type of request thanks to the very open system of our solution, allowing:
- to integrate an infinite number of sensor brands selected according to the user's requirements and needs,
- to transmit data in any language,
- to transform wired data into non-wired or < br>- to send information such as light signals"
LYRA software
From a software point of view, the two cabinets are brought together in a single common environment.
The software used for data feedback meets the requirements of 21 CFR part 11 and is designed in line with GAMP5 recommendations. It is supplied in the form of a subscription, in drawer-on-demand mode, allowing flexibility adapted to individual needs with no hidden costs.
Development in agile mode using current scrum technologies in 3 consecutive modes - dev - staging - prod - means that we can make regular improvements while remaining very robust when it comes to commissioning a new version.
A technical and commercial success for the EMS development team, thanks to their expertise and ability to adapt to the customer’s specific requirements.
