MET has ISO 11608 Testing Accredited to ISO 17025
Aug 1, 2017
ISO 11608 is the key reference for design validation testing of prefilled syringes and injector pens. It details safety and performance requirements, such as dose accuracy under wide range of environmental conditions. As well as temperature challenges, resistance to vibration and shock are included. It guides the development of a design validation protocol to demonstrate robust, reliable injector performance.
MET’s laboratories have now added ISO 11608 to our accreditation under our ISO 17025 quality management system. Approved tests include: dose accuracy across regions, actuation forces and transit resistance.
ISO 17025 is the laboratory version of ISO 9000. It contains the standard QMS rules, which are supplemented by additional items such as; sample control and verification of results. Additionally, competence in specific analyses is assessed and accredited. Included in the scope are a very wide variety of test service suppliers and calibration organisations. Test protocols and their implementation are qualified in inter-laboratory studies or by comparison of results found by different technicians.
MET’s accreditations now include sterile barrier testing, shelf life studies and the ISO 11608 test regime. Please view our certificate here. We are audited by UKAS is the only government recognised accreditation body for test laboratories in the United Kingdom. They operate globally and their association with international groups such as EA, IAF and ILAC, provides for mutual recognition.
Injector pens for testing to ISO 11608
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