2016 Temp Mapping Summary

During 2016, Performance Validation executed 29 projects that included a temperature mapping component of project work where we utilized PV’s mapping equipment.  These projects were completed with multiple clients, across both Pharmaceutical and Medical Device life science industries.  These projects included mapping studies using PV’s own inventory of Vaisala Veriteq data loggers measuring temperature only, or temperature and humidity, or using the Kaye Validator 2000 for projects involving extreme cold or heat.  Performance Validation maintains its temperature mapping equipment in a calibrated and validated state for use in the regulated life science industry.  A summary of the types of equipment mapped during 2016 are identified below:

Sub-Freezers/Cryogenic Storage:
Using the Veriteq 1416 low temperature loggers, completed a -80C ultra low freezer qualification for a contract pharmaceutical packaging company.

Using the Kaye Validator 2000:

  • Completed two liquid nitrogen dewar qualifications for an animal health manufacturer cell culture lab.
  • Completed an engineering study to verify cryo vessel storage temperatures during permanent monitoring system RTD thaw for a large pharmaceutical manufacturer central cell bank facility.

USP Freezers:
Using Veriteq VL temperature loggers:

  • Completed two reach-in freezer qualifications for a large pharmaceutical manufacturer.
  • Completed mapping of two walk-in freezers for a life sciences logistics provider.
  • Completed mapping of a large clinical trials walk-in warehouse freezer for a large pharmaceutical manufacturer.

USP Cold Storage Refrigerators or Chill Rooms:
Using Veriteq VL temperature loggers:

  • Completed two reach-in refrigerator qualifications for a large pharmaceutical manufacturer.
  • Completed mapping of two walk-in coolers for a life sciences logistics provider.
  • Completed mapping of a new large clinical trials walk-in warehouse cooler for a large pharmaceutical manufacturer.
  • Completed a walk-in cooler and a packaging room refrigerator qualification for a contract pharmaceutical packaging company.
  • Completed a new reach-in refrigerator qualification for an animal health manufacturer cell culture lab.
  • Completed a cold room mapping for a generic animal health manufacturer.
  • Completed mapping of three walk-in coolers at two different sites for a specialty distribution and solutions provider.
  • Completed mapping of four reach-in coolers for a pharmacy services company.

USP Controlled Room Temperature, Water Baths, or Incubators/Stability Chambers:
Using Veriteq VL temperature and humidity data loggers:

  • 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 a number of local and remote seasonal temperature mappings for multiple third party drug storage and distribution warehouses and provided recommendations for permanent monitoring locations within those facilities.
  • Completed mapping of a new large clinical trials warehouse for a large pharmaceutical manufacturer.
  • 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 several reach-in stability chamber requalifications for a lab facility at a large animal health manufacturer.
  • Completed several shaker incubator qualifications for a cell culture lab at a large animal health manufacturer.  
  • Completed several incubator/stability chamber qualifications for a large pharmaceutical manufacturer and a large combination device manufacturer.  

Autoclaves, Sterilizers, Steam-in-place (SIP):
Using the Kaye Validator 2000:

  • Completed revalidation of several different steam autoclave loads for multiple steam autoclaves for a central cell bank lab and a culture lab at a large pharmaceutical manufacturer.
  • Completed initial validation of several different steam autoclave loads for two new autoclaves for a cell culture lab at a large animal health manufacturer.

In summary, Performance Validation supported a wide range of temperature mapping activities for a broad range of clients, small and large, pharma and non-pharma, in 2016.  In addition to the projects detailed above and as another available service, Performance Validation rented Veriteq data loggers and Kaye Validator 2000 equipment to several different clients for internal completion of mapping work throughout 2016.  PV has the experience, expertise, and equipment to support the temperature mapping needs of the regulated life science industry.

For additional information contact:
Neil Enlow
Principal Validation Engineer
Performance Validation, LLC
Cell: (317) 341-2819