A shift in focus to quality-by-design rather than quality-by-test, along with an increased focus on patient safety and product quality, has lead to increased focus on controlling and monitoring storage conditions. Warehouse and storage area mapping is a key element of meeting USP 1079 and cGMPs in the biotech/pharmaceutical industries, especially when concerning environmentally sensitive products or process components.
Temperature and humidity mapping is performed per customer or Masy BioServices protocol, and the mean kinetic temperature (MKT) is calculated in addition to statistical calculations for each parameter (per the protocol). MKT calculations shows the effect of above or below average temperature readings on stored product, as single high or low readings have a greater effect on the MKT than the statistical average.
Warehouse mapping is typically done seasonally (winter and summer), though some applications require less frequent mapping. The purpose of the seasonal mapping is to see the affect of seasonal climate changes on the environmental conditions being tested.
Masy employs trained validation engineers and specialists, and has available a fleet of wireless data loggers and related equipment required for all warehouse and storage area mapping. We will execute the warehouse qualification protocol using sensors with a NIST-traceable calibration for both temperature and humidity. Pre-study calibrations and post-study calibration verifications can be performed on the test instruments at Masy BioServices in our primary standards lab.
Contact Masy BioServices today for your warehouse mapping needs.