In the world of industrial production, product quality and safety are essential. In particular, they are in sensitive sectors such as pharmaceuticals and electro-medical. In order to ensure that systems, equipment and production processes function correctly, a validation process divided into different phases is used.
One of the most critical phases is Performance Qualification (PQ), or performance qualification.
What is Performance Qualification (PQ)?
Performance Qualification is a crucial phase in the qualification cycle that verifies whether a piece of equipment or a production process is able to function consistently and effectively in real operating conditions. In other words, PQ is used to test the actual ability of the system to produce results compliant with specifications when used for its intended function.
The Role of ISO and IEC Standards
Organizations such as ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) play a key role in defining guidelines and requirements for the validation of processes and equipment. For example, the ISO 13485 standard, specific to medical devices, provides quality management guidelines that include the validation of production processes.
Another relevant example is the IEC 60601 standard, which concerns the safety and performance of electromedical equipment. These standards do not explicitly mention PQ, but require that each device or process involving critical equipment be tested and qualified, which also includes the Performance Qualification phase.
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The Importance of PQ in the Electromedical Sector
The electromedical sector is an example to explain the difference between safety standards in the production of equipment, such as ISO and PQ proper. In fact, electromedical instruments must function safely and effectively during clinical use but also achieve a certain level of performance. Instruments such as defibrillators, ventilators or blood pressure monitoring devices must demonstrate that they can operate accurately in complex and variable environments, such as hospitals or clinics, and maintain high performance standards.
Climatic Chambers for Electromedical Testing
To ensure that electromedical devices are actually ready for use in any condition, a fundamental element of the PQ phase is the climatic chamber test.
Climatic chambers allow you to simulate a wide variety of environmental conditions, including extreme ones, to check whether the equipment can function correctly even in non-optimal conditions.
For example, a mechanical ventilator could be tested in a climatic chamber to ensure that it functions correctly both at very low temperatures and in hot and humid environments, thus ensuring that the device can be used safely in different parts of the world.
Here we have discussed in more detail the climatic chamber test on electromedical devices.
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The FDM Climatic Chamber for PQ
For over 70 years, FDM - Environment Makers has been designing climatic chambers approved to the best international standards.
Our climatic chambers are able to perform all the tests we have talked about and ensure the Performance Quality of your products.
FDM can draft the PQ (or IQ-OQ) procedures for you that a third party will implement at your business, or it is possible to send one of our technicians directly on site to implement the same procedures we created.
For further doubts and questions, please do not hesitate to contact us.
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