Masy BioServices- Calibration Services, GMP Validation, & Biostorage

05/22/2018

Summer validation isn’t just about looking good in a swimsuit once the warm temperatures hit, it’s about safeguarding your products and inventory when the outside humidity and temperatures shift as well. Even in a climate controlled environment, what’s happening outside can affect your warehouse and chambers in unexpected ways that can put the integrity and quality of your products at risk. Warehouse thermal mapping is critical to meeting USP 1079 as well as maintaining cGMP and cGxP. Small deviations in temperature and humidity can have big consequences and thermal mapping your warehouse is essential in both winter and summer to assure product and, ultimately, patient safety. 

Validation and Qualification

Key equipment is also susceptible to performance changes in the summer months as it may work harder to stay at peak operating temperature in response to external environmental factors or internal ones such as continuous AC or lack of AC.

Masy's thorough validation services provide confidence in product safety by making certain that environmental conditions are optimal and equipment is performing up to expectations.

Our team of Validation Engineers makes it easy and cost-effective, as we customize temperature & humidity mapping solutions to your specific needs. We perform IQ, OQ and PQ and have particular expertise in large warehouse thermal mapping and large scale multiple chamber qualification. We also help small labs and start-ups meet regulatory compliance, bringing best in class processes they need to compete and thrive. 

Masy uses precise humidity and temperature sensors to assure all thermal mapping, validation and qualification projects are done to the most exacting standards. We only uses sensors with a NIST-traceable calibration performed in our primary standards lab. Pre-study calibrations and post-study calibration verifications will also be performed by our skilled technicians. In addition to statistical calculations for each measured parameter-- whether a custom protocol or following your Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols in accordance with US Food and Drug Administration-- mean kinetic temperature (MKT) is calculated. MKT calculations demonstrate 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.

Masy has provided expert validation and qualification services for over 35 years and our warehouse thermal mapping is an integral component to our business and yours, as losing product is never in anyone’s best interest. Contact Masy for summer mapping today.

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