2015 Temperature Mapping Project(s) Summary

During 2015, Performance Validation executed 33 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 2015 are identified below:

Sub-Freezers:


Using the Vaisala DL1016-1416 low temperature loggers, completed several -80C sub-freezer qualifications for a central cell bank lab at a large pharmaceutical manufacturer.

USP Freezers:


Using Veriteq (Vaisala) VL temperature loggers:
-Completed a raw material walk-in freezer qualification for a contract pharmaceutical manufacturer.
-Completed a new freezer qualification for a central cell bank lab at a large pharmaceutical manufacturer.

USP Cold Storage Refrigerators or Chill Rooms:


Using Veriteq (Vaisala) VL temperature loggers:
-Completed a reach-in refrigerator qualification for a pharmaceutical contract manufacturing company.
-Completed several walk-in chill room qualifications for a large pharmaceutical manufacturer.

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


Using Veriteq (Vaisala) VL temperature and humidity data loggers:
-Completed a new reach-in stability chamber qualification for a pharma contract research laboratory.
-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, 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 culture lab facility at a large pharmaceutical manufacturer.
-Completed several incubator qualifications for a central cell bank lab at a large pharmaceutical 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 a new steam autoclave for a pharma contract research laboratory.

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 2015. In addition to the projects detailed above and as another available service, Performance Validation rented Veriteq (Vaisala) data loggers and Kaye Validator 2000 equipment to several different clients for internal completion of mapping work throughout 2015. 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