Our partner ROTRONIC offers solutions for medical device manufacturers, especially oxygen ventilators; with sensors to detect O2 leakage
Our partner ROTRONIC is part of the PST (Process Sensing Technologies) group, which provides solutions for medical device manufacturers, especially oxygen ventilators. For the latter, it offers a wide range of oxygen sensors for leak detection. It also includes a monitoring system (RMS). The monitoring system helps ensure product quality. It also helps the manufacturer of regulated medical devices to comply with the required regulations. These include FDA 21 CFR-part 820 and ISO 13485 and ISO 14644.
The main aim of an oxygen ventilator is to deliver an oxygen mixture that helps the patient breathe. Manufacturers of oxygen ventilators must ensure that the medical device is safe for the patient’s use. At the same time, users should be warned of the potential dangers of use.
Medical device manufacturers selling non-invasive oxygen ventilators must comply with IEC 60601-1. The latter relates to the safety and performance of medical electrical equipment.
PST offers a range of sensors using different sensor technologies that comply with IEC 60601-1. They are classified as:
– optical (SST LuminOx optical oxygen sensor),
– zirconium (SST miniature zirconium oxygen sensor),
Their expertise can help you determine which technology is best suited to your oxygen fan, depending on your needs. V app you can find a range of PST sensors with more detailed descriptions and purpose.
Medical devices are products regulated by the FDA (a government agency within the US Department of Health, Food and Drug Administration). The FDA, as the world’s most influential agency in this field, requires manufacturers to establish and maintain quality systems to ensure the usability and safety of products. Quality systems for FDA-regulated products are based on Good Manufacturing Practices, or GMP. GMP compliance requirements for medical devices are described in the Federal Code. The same GMP rules are also implemented by the EMA (European Medicines Agency).
ROTRONIC Monitoring System (RMS) is a real-time environmental monitoring system designed for GMP applications. It helps control critical process parameters that ensure product quality.
RMS is an FDA 21 CFR compliant software solution offering full data integrity for recording purposes.
RMS helps to meet the following ISO 13485 requirements:
– 6.3 Infrastructure
– 6.4 Working environment and pollution control
– 7.5.1 Control of the supply of production and services
– 7.5.6 Validation of processes for the supply of production and services
PST consists of a group of manufacturers who together provide an unparalleled collection of instruments, analysers and sensors for precision measurements in industrial process control, environmental monitoring, natural gas and petrochemical processing, and food and drug applications. PST Group provides support, service and calibrations for control and monitoring equipment and calibration processes as well as validations based on GAMP®5 recommendations worldwide.
PST also offers solutions for monitoring compliance with ISO 14644 for clean rooms and related controlled environments.
PST also offers a range of services for GMP applications such as:
Cost savings; increased energy efficiency with reduced process disruption; direct improvements in profitability; maintaining compliance with strict industrial regulations.
Author Katarina Žunko, source PST: ”Solutions for oxygen ventilator medical device manufacturers”