IQ/OQ for Refrigerators
In some clinical trials the highest standards in the compliance of the storage temperature may be required. A well documented qualification (IQ/OQ) of the refrigerator on site is then practically mandatory.
During the IQ/OQ a number of parameters are checked and subsequently a 24 h temperature mapping is performed at 9 defined positions. During this period, a door opening event is simulated. The results are documented in a comprehensive IQ/OQ report. Typically, the refrigerator is loaded with dummies to simulate a realistic setting.
The IQ/OQ process starting from drawing up specific IQ/OQ documents up to performing the actual IQ/OQ on site is usually performed in a close collaboration with the customer’s QA division.
LABFISH offers IQ/OQ services for all rental instruments.
IQ/OQ FOR OTHER EQUIPMENT
Usually, IQ/OQ during clinical trials is required for refrigerators. Some clinical trials also require IQ/OQs for other equipment like centrifuges.
For more information:
The Labfish Quality – IQ/OQ