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Guest blog: Temperature mapping studies - Simplifying with validation services

thermal validation, temperature mapping services - Validation & Qualification
Nathan Roman, Validation Director, Genesis AEC
Nathan Roman, Genesis AEC
Director of Validation
Published: Mar 23, 2022
Life Science

What is the current state of how GxP industry performs temperature mapping?


Current Good Manufacturing Practice (CGMP), according to the FDA's Code of Federal Regulations Title 21, requires that environments used to manufacture or process drug products be validated to ensure a high degree of quality and efficacy.  Each firm is responsible for selecting suitable equipment used in research and development, manufacturing, or storage to produce quality products in accordance with CGMP.

Handling of equipment, calibration, maintenance, including temperature and/or humidity mapping, qualification, or validation of storage environments must be performed to ensure conditions match the stability requirements of the products. This is also a requirement as per international standards to ensure that the products are always stored and distributed within the specified temperature limits.

To ensure and demonstrate that proper environmental conditions and temperature and /or humidity controls are obtained, qualification and/or validation is expected to be carried out. Temperature Mapping studies must be carried out regularly as part of the equipment installation and operational qualification (IOQ) to ensure that an environmental room or controlled temperature chamber is capable of accurate and repeatable performance.

Temperature Mapping Studies: Equipment Qualification

A properly developed qualification protocol will help ensure that the 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.

Generally, a protocol contains a documented approach to conduct the qualification process along with the procedure, scope, equipment description, responsibilities, test method, IQ/OQ/PQ test scripts, acceptance criteria, report and approval. 

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, periodic reviews and also provides examples and sample templates.

Quick Guide to Mapping Protocols

Here is a list of what a basic temperature mapping protocol should contain:

Installation Qualification

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

Operational Qualification

  • 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

  • Loaded Chamber Temperature Mapping Study
    Note: When determining mapping locations, the potential storage location should be considered. Probe locations; number of probes, distance between probes, usable space, direct path of air flow.

The goals of the qualification and mapping study’s can be summarized as: 

  • To demonstrate environmental uniformity for temperature and sometimes humidity
  • To identify unsuitable storage locations within an area
  • To determine representative monitoring points

Prior to performing a qualification or requalification on any controlled temperature unit, ensure you have all documentation required to meet the manufacturer and site requirements. It’s recommended to physically see the unit prior to starting any documentation to ensure that all the supplies/materials are all accounted for in order to meet the site requirements.

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

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Vaisala Validation/Qualification Services

Vaisala Mapping Service is offered in Great Britain, Europe, and Japan.

Learn more about Vaisala's mapping system

See how simple vLog software validation is in our vLog Installation/Operational protocol sample


Trusted Validation/Qualification Service Providers in America

In North Americas, these services can be provided by trusted providers in CQV who use Vaisala solutions. 

“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 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. Once I discovered the Vaisala data loggers and the vlog software, we saved a ton of time on mapping applications…” 

-    Nathan Roman, Director Validation Services, Genesis AEC
Learn about services from Genesis AEC services

“The vLog software is extremely easy to use. The system is comparatively user friendly and much simpler than any of the other systems we’ve tried. The batch setup feature is a huge time saver when using a large number of loggers and the graphs and reports are easily configurable to meet our needs. We recently had one large pharmaceutical customer who had experienced some issues with a non-Vaisala thermal validation system. The company had concerns with the accuracy of the devices and quality of the calibrations and documentation. They made an internal decision to use only Vaisala data loggers for thermal validation.”

-    Neil Enlow, Principal Engineer with Performance Validation
Learn about services from Performance Validation

For more information on Vaisala’s Environmental Validation and Qualification solutions, please see our brochure, or contact your local service center.

References:

Industry Guidelines:
There are many guidelines currently available on controlled temperature units and mapping guidelines. 

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Webinar on Qualifying Temperature Controlled Chambers and Validating for CGMP

Webinar: Controlled temperature chambers: qualification, mapping & monitoring

In this webinar, Genesis AEC's Validation Director Nathan Roman and Vaisala's Senior Regulatory Expert Paul Daniel discuss their industry experience with CTCs and their personal contributions to the recent revision of the ISPE's "Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring".

Join the discussion to learn how industry is solving old challenges in new ways. 

Agenda: 

  • History of Good Distribution Practice & the importance of mapping
  • Sensor choices for mapping and monitoring 
  • Calibration and qualification
  • Active vs passive CTCs
  • Best practice for documenting CTC qualification
  • Updates to the ISPE’s CTC Good Practice Guide

Learn more

GAMP & GxP Validation

The viewLinc Continuous Monitoring System is ideal for GxP/FDA-regulated applications and environments that contain high-value products. If you are required to maintain compliant environmental monitoring methods and documentation, we recommend you validate your viewLinc monitoring system.  A GxP-compliant Installation Qualification and Operation Qualification protocol document (view sample) is available from Vaisala. This IQOQ document is based on best practices in software validation outlined by regulatory bodies and GAMP5 principles. The documents ensure your system is installed correctly and will perform as expected. Ideally, IQOQ testing is performed by a qualified technician from your firm. Alternatively, you can have your system validation performed by Vaisala's skilled Field Services technicians.

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Roberto Eligio

May 3, 2022
Learn to mapping

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