2017 Temp Mapping Summary


2017 Temp Mapping Summary

During 2017, Performance Validation executed 31 projects that included a temperature mapping component of project work.  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 2017 are identified below:

Sub-Freezers/Cryogenic Storage:

Using the Veriteq 1416 low temperature loggers, completed a -80C ultra low freezer qualification for a large pharmaceutical manufacturer central cell bank facility.

Using the Kaye Validator 2000:

  • Completed a walk-in freezer qualification for a plasma processing/storage facility.
  • Completed a cryo storage vessel qualification for a large pharmaceutical manufacturer central cell bank facility.

USP Freezers:

Using Veriteq VL temperature loggers:

  • Completed a reach-in freezer qualification for a large pharmaceutical manufacturer fermentation culture lab.
  • Completed qualification of a new walk-in freezer and three existing reach-in freezers for a third party drug storage and distribution provider.

USP Cold Storage Refrigerators or Chill Rooms:

Using Veriteq VL temperature loggers:

  • Completed two new reach-in refrigerator qualifications for a large pharmaceutical manufacturer central cell bank facility.
  • Completed qualification of a new walk-in cooler and seven existing reach-in coolers for a third party drug storage and distribution provider.
  • Completed walk-in cooler and packaging room refrigerator qualifications for a contract pharmaceutical packaging company.
  • Completed several cold room mappings for a large pharmaceutical manufacturer.

USP Controlled Room Temperature, Water Baths, or Incubators/Stability Chambers:

Using Veriteq VL temperature and humidity data loggers:

  • 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 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 hot room mappings for a large pharmaceutical manufacturer.
  • Completed two new shaker incubator qualifications for a large pharmaceutical manufacturer central cell bank facility.
  • 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.
  • Worked through a stability chamber manufacturer to complete three walk-in stability chamber qualifications and an oven qualification for a large medical device manufacturer engineering test lab.

Autoclaves, Sterilizers, Steam-in-place (SIP):

Using the Kaye Validator 2000:

  • Completed validation of several different steam autoclave loads for an R&D lab for a large animal health manufacturer.
  • Completed annual revalidation of several different steam autoclave loads for two autoclaves for a cell culture lab at a large animal health manufacturer.
  • Completed annual revalidation of several different steam autoclave loads for two autoclaves for a fermentation culture lab and three autoclaves for a central cell bank facility for a large pharmaceutical 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 2017.  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 2017.  PV has the experience, expertise, and equipment to support the temperature mapping needs of the regulated life science industry.

For additional information on how Performance Validation can assist you with your mapping needs please contact Neil Enlow or use our contact us form.

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