Temperature Mapping Studies: Equipment Qualification Protocols

Biotech & Pharma’s most common way of establishing evidence or documenting test results is through the implementation of Protocols. 

That is why it is critical that all documentation follows good documentation practices (GDP). Documentation is the basis for all validation (and all GxP) activities.

Along with essential design and planning documents such as;

• User Requirement Specification (URS)
• Risk Assessment (RA)
• Design Review/ Design Qualification (DR/DQ)
• Validation Master Plan (VMP)

Protocols, such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), are the building blocks of the validation framework.

Protocol Generation

A properly developed qualification protocol will help ensure that your equipment meets all documentation requirements and performs as expected, including the temperature mapping study is correctly carried out.

A trusted validation service provider can work with you to determine whether your qualification protocol is sufficient or help you generate a protocol to meet your requirements.

Biotech & Pharma companies must ensure and demonstrate proper environmental conditions, temperature and /or humidity controls are obtained, and qualification and/or validation is expected to be carried out.

Temperature Mapping studies must be performed regularly as part of the equipment installation and operational qualification (IQ/OQ).

Generally, a protocol contains a documented approach to conduct the qualification process which includes;

• Purpose
• Scope
• Responsibilities
• Equipment/System Description
• Installation Qualification (IQ) Verification
• Operational Qualification (OQ) Verification
• References
• Exceptional Conditions or Protocol Deviations
• Summary Report
• Post-Execution Approval 

We all need proper guidance

Since these concepts are not entirely always clear, the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition) provides guidance on commissioning and qualification, temperature mapping, maintenance and periodic reviews - it also provides examples and sample templates.

Please be sure to reach out to me if you need any Temperature Mapping Support.

IQ/OQ/PQ (test scripts)

Here is a list of what a basic controlled temperature chamber qualification (temperature mapping protocol) should contain:

Installation Qualification IQ

• Standard Operating Procedure Verification
• Equipment and Utility Installation Verification
• Documentation and Drawings Verification
• Calibration Status of Critical Instruments
• Test Instrument Calibration Information

Operational Qualification OQ

• Operational Controls and Setpoint Verification 
• Alarm Verification
• Empty Chamber Temperature Mapping Study
• Additional qualification tests may include (as applicable – often for reference only): Open Door Verification test, Power Loss Temperature test

Performance Qualification PQ

• Loaded Chamber Temperature Mapping Study

Mapping location tip

When determining mapping locations, the potential storage location should be considered.

Note: Some products are sensitive to light or humidity. They will have a label saying to “store in a cool dry place or protect from light”.

Other probe location considerations:

• number of probes,
• distance between probes,
• usable space,
• direct path of air flow

By following the basic principles listed above, you will be on your way to successfully completing a temperature mapping study and well prepared for your next qualification.

Wrap up

Everybody knows what needs to be done, but they’re not always sure how to get there. We know how to get there because that’s what we do, over and over again. We do these things in ways that have been proven to be effective. We look at a process or system based on its objective, then we guide our clients to better solutions.  -   Nathan Roman, Director Validation Services

Here to help

To learn more about Temperature Mapping locations, recording intervals, pre/post calibration, protocol generation or would like help with your general validation needs please contact us directly at [email protected]