Winter is fast approaching in the US and soon there will be snow and ice covering the land! While nice for the holidays, those of us that are concerned about USP temperature controlled storage areas – winter brings with it the need to perform Winter Mapping. Do you have a continuous temperature monitoring system in place with a robust documented temperature mapping analysis of your storage space? USP guidelines require extreme seasonal temperature mappings to be performed where product storage temperatures are critical. Have you had increasing internal or external requests to demonstrate adequate temperature and/or humidity control within your facility?
Performance Validation has the resources and experience necessary to help provide a documented temperature mapping analysis of your facility, cold room, refrigerator, or freezer. Check out our project summaries for 2017 that identify the work performed by our Georgia team, or the 2016 summary that details the work executed with Performance Validation’s own mapping equipment. Our internally developed mapping/qualification protocol templates have been created based on USP guidelines and best industry practices and can be modified for your application quickly.
With offices and teams located in Indiana, Illinois, Michigan, Kansas, Georgia, and New Jersey – PV can provide a local solution to help meet your needs. Not located nearby? Our portable wireless data loggers can be programmed at our office, sent to your site for installation with your assistance, and returned to us for data download and analysis.
We are committed to providing our clients with up to date strategies that reflect changes in cGMPs and interpretation of regulatory guidelines. Performance Validation has earned a strong reputation for quality, integrity, and a willingness to work with other vendors and contractors in providing solutions for our customers. We also pride ourselves on our flexibility to meet our clients’ needs, whether we are supplementing their current staff or managing an entire project.