The Challenge

A large international airline company needed to have temperature controlled storage at two major U.S. airports for the transport and short-term storage of Time and Temperature Sensitive Products (TTSPs).  As part of IATA’s (International Air Transport Association’s) certification process, a temperature mapping is required of all temperature controlled storage areas to be used for this purpose.  This particular airline chose to have two 53’ conditioned trailers permanently docked at each airport location, one to be used for room temperature storage and the other to be used for refrigerated storage.  Additionally, a walk-in freezer was added to one of the locations for frozen storage capability.

The Solution

Performance Validation (PV) was selected for the project because of their extensive temperature mapping experience within the pharmaceutical industry.  Additionally, the airline company felt the mapping package offered by PV would adequately and completely satisfy the requirements of the IATA.  PV was responsible for development and execution of the initial and subsequent summer season mapping documentation for all of the temperature controlled storage areas at both locations.  PV was integral to the project from the mapping protocol development phase, working with airline personnel for the mapping execution, analyzing and summarizing the mapping results, and providing guidance on permanent monitoring sensor installation/placement.

The Results

The customer was very pleased with mapping protocol development, execution, and management by PV.  Although new to the IATA certification process and to working with an airline customer, PV was able to research the current governing IATA Temperature Control Regulations (TCR) standard and incorporate the associated World Health Organization (WHO) guidance for temperature mapping of storage areas to confidently provide a fully compliant documented mapping for the customer. PV communicated very well with the customer and fostered a collaborative effort, getting review and agreement from key stakeholders, throughout the entire project.

The Benefits 

The project accomplished the following for the airline cargo company:

• Provided complete and thorough initial and summer season temperature mapping documentation for all temperature controlled storage areas at both airport locations to support IATA certification for transport and storage of TTSPs.
• Provided justification for the installation and location of permanent monitoring devices for long term monitoring/alarm of all temperature controlled storage areas.
• Demonstrated impact of door openings on storage area temperatures to provide guidance on acceptable door open durations and permanent monitoring system alarm settings.

Have a question on the design, development, or implementation of a mapping study for temperature controlled storage?  If so, please contact us using use our Contact Us form and one of Performance Validation’s team members will be in touch.

About Performance Validation:  Performance Validation is a 100% employee-owned company serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.  We are not a virtual company, a staffing agency, or a “body shop.”  Our projects are managed and staffed by our own employees. We live by our Mission, which is to provide our clients with peace of mind, and we have been doing so for more than 30 years.

For more information:

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