Monitoring system, a method for monitoring, and a room
AssigneeGEA Process Engineering nv
InventorsJames William Holman, Phillip Michael Gabb
Life of this patent
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Abstract
Disclosed is a monitoring system for monitoring performance of a contained system for processing pharmaceutical components, the contained system comprising one or more inlets for receiving one or more pharmaceutical components and one or more outlets, the monitoring system comprising a first sensor and a processing unit operationally connectable to the first sensor. Also disclosed is a method for monitoring performance of a contained system for processing pharmaceutical components and a room comprising a contained system and the monitoring system.
Claims20
A monitoring system for monitoring performance of a contained system for processing pharmaceutical components, the contained system comprising one or more inlets for receiving one or more pharmaceutical components and one or more outlets,
- the monitoring system comprising a first sensor and a processing unit operationally connectable to the first sensor, wherein the first sensor is configured to be arranged outside of the contained system at a first point, and the first sensor is configured to repeatedly provide to the processing unit a sensor signal indicative of a particle concentration of particles from the one or more pharmaceutical components having a size larger than 0.1 micrometre in air outside the contained system,
- wherein the processing unit is configured to compare the sensor signal with an expected sensor signal, and
- wherein the processing unit, where the processing unit determines that the sensor signal is different from the expected sensor signal, is configured to output an output signal indicative of an air particle concentration being different than an expected air particle concentration to indicate a containment breach of the contained system.
A method for monitoring performance of a contained system for processing pharmaceutical components, the contained system comprising one or more inlets for receiving one or more pharmaceutical components and one or more outlets, the method comprising:
- identifying a first potential leakage zone;
- arranging a first sensor outside the contained system in proximity to the first potential leakage zone, the first sensor being configured to repeatedly provide a sensor signal indicative of a particle concentration in the air of particles from the one or more pharmaceutical components;
- and
- determining a performance of the contained system based on the sensor signal,
- wherein the step of determining a performance of the contained system comprises comparing the sensor signal with an expected sensor signal, and where it is determined that the sensor signal is different from the expected sensor signal, outputting an output signal indicative of an air particle concentration being different than an expected air particle concentration to indicate a containment breach of the contained system.
A room comprising:
- a contained system for processing pharmaceutical components, the contained system comprising one or more inlets for receiving one or more pharmaceutical components and one or more outlets, and
- a monitoring system for monitoring performance of the contained system, the monitoring system comprising a first sensor and a processing unit operationally connectable to the first sensor, wherein the first sensor is configured to be arranged outside of the contained system at a first point, and the first sensor is configured to repeatedly provide to the processing unit a sensor signal indicative of a particle concentration of particles from the one or more pharmaceutical components having a size larger than 0.1 micrometre in air outside the contained system,
- wherein the processing unit is configured to compare the sensor signal with an expected sensor signal, and
- wherein the processing unit, where the processing unit determines that the sensor signal is different from the expected sensor signal, is configured to output an output signal indicative of an air particle concentration being different than an expected air particle concentration to indicate a containment breach of the contained system.
Dependencies are inferred from the claim text.