2014 Temperature Mapping Project(s) Summary

During 2014, Performance Validation executed 34 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 2014 are identified below:

Sub-Freezers:

Using the Kaye Validator 2000, completed several -80C sub-freezer qualifications for a pharma contract manufacturer.

USP Freezers:

Using Veriteq VL temperature loggers:

  • Completed a raw material walk-in and reach-in freezer qualification for a contract pharmaceutical manufacturer.
  • Completed a new freezer qualification for a central cell bank lab at a large pharmaceutical manufacturer.
  • Completed several walk-in freezer re-qualifications for contract pharmaceutical manufacturers.

USP Cold Storage Refrigerators or Chill Rooms:

Using Veriteq VL temperature loggers:

  • Completed a walk-in chill room re-qualification for a large pharmaceutical manufacturing company.
  • Completed a new walk-in chill room qualification for a pharmacy services provider.
  • Completed walk-in chill room and reach-in refrigerator temperature mappings for a pharmaceutical and medical supply company.

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

Using Veriteq VL temperature and humidity data loggers:

  • Completed a number of walk-in stability chamber qualifications and requalifications for a pharma contract manufacturer.
  • Completed a number of 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 and storage areas.
  • Completed several reach-in stability chamber qualifications and requalifications for a lab facility at a large animal health manufacturer.
  • Completed several shaker incubator qualifications for a lab facility at a large pharmaceutical manufacturer.

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

Using the Kaye Validator 2000, completed revalidations of several different steam autoclave loads for a pharma contract manufacturer.

Equipment Rental:

Performance Validation maintains its temperature mapping equipment in a calibrated and validated state for use in the regulated life science industry. As part of our Temperature Mapping Service Offering, Performance Validation rents our temperature mapping equipment to clients for internal execution of Temperature Mapping Work. Our equipment available for rental includes:

    • Veriteq Data Loggers
      • VL2000 Temp & RH, Ranges -25 to +70C, 10-90%RH
      • VL1000 Temp, Range -25 to +70C
      • VL1416 Low Temp, Qty (4 external sensors each), -90 to +50C
      • Net Book computers with the validated applications installed for your use
    • Kaye Validator 2000 Equipment
      • Kaye 2000 Unit, SIMS, & IRTD
      • LTR-140 Temp Bath -25 to 140C
      • Thermocouples – Performance Validation can make up TC’s to your needs, priced / foot.
      • Net Book computers with the validated applications installed for your use

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 2014. Additionally, Performance Validation has provided Veriteq data loggers and Kaye Validator 2000 equipment for rent to several different clients for internal completion of mapping work throughout 2014. PV has the experience, expertise, and equipment to support the temperature mapping needs of the regulated life science industry. Contact us to request a quote for your mapping or equipment needs.

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