Performance Validation has extensive experience with controlled temperature and humidity storage mapping projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries.  These projects included mapping studies using PV’s own inventory of wireless Vaisala temperature and humidity data loggers.

Performance Validation resources have expertise with determining logger placement for mapping, identifying locations for permanent monitoring sensors, and working with our clients to resolve hot/cold spot issues.  For a more cost effective solution, PV has developed standard temperature mapping templates and reports for almost any application and, with help from our clients, are able to perform most mappings nationwide remotely.  A summary of the types of recent projects completed are identified below:

  • Developed and executed local and remote initial/seasonal temperature mappings for third party drug storage and distribution warehouses or raw material storage areas within pharmaceutical manufacturing facilities and provided recommendations for permanent monitoring locations within those facilities.
  • Completed a number of controlled area HVAC requalifications for a large dry products pharmaceutical manufacturer to verify temperature and humidity requirements within critical manufacturing, storage, and packaging areas.
  • Completed a warehouse and sample retention room mapping for a generic animal health manufacturer.
  • Completed a secondary packaging room temperature study for a contract pharmaceutical packaging company.
  • Completed initial and seasonal mapping of a new large clinical trials warehouse for a large pharmaceutical manufacturer.
  • Completed sample weigh room, secondary packaging room, and storage warehouse seasonal temperature and humidity studies for a contract pharmaceutical packaging company.
  • Completed remote winter and summer seasonal temperature mappings for a third party drug storage and distribution warehouse.
  • Completed a temperature/humidity study of a QC lab for a large combination device and pharmaceutical manufacturer.
  • Completed a summer season warehouse mapping for a large pharmaceutical manufacturer.
  • Completed seasonal warehouse temperature/humidity mappings for a veterinary drug distributor.
  • Completed validation of two new large distribution center/warehouse facilities, including walk-in coolers and DEA vaults for a large pharmaceutical manufacturer. Mapping included empty chamber, loaded chamber, door open/recovery, and power loss studies.

For additional information regarding controlled room temperature, please schedule a call with one of our subject matters experts. . 

Neil Enlow

Principal Validation Engineer

Performance Validation, Inc.

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