Testing & Quality

To assure the outstanding quality of used materials and technologies, permanent testing and product development is needed. Our testing laboratory is equipped with devices that enable to measure a number of qualities, which are important for complete product evaluation. Continuous research is a foundation for new efficient products.
Pharma Systems makes daily in-house tests to ensure quality and to find the best solutions for manufacturing and use of HME and filter media. For the filtration efficiency evaluation our laboratory uses TSI Certitest 8310, recommended in the standard ISO23328-1 (Breathing system filters for anaesthetic and respiratory use – Part 1: Salt test method to assess filtration performance.)

The test rig for the HME efficiency testing is built in accordance with ISO 9360 (Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml). Every important parameter is measured and recorded through complete test duration.

 

In addition to our own test laboratoryr other testing sources are used for indipendent evauation.

Audited by Intertek

Pharma Systems is a certified and approved manufacturer holding the following certificates:

  • EN ISO 13485:2012
  • MDD 93/42/EEC

Pharma Systems manufacturing sites are FDA registered.