Thermal Mapping Protocol Template – Validation Free Sample Download

CIQA Thermal Mapping Protocol Template - Full Version - front page 1

 

In this article, you will learn how to download and use a thermal mapping protocol template to perform a temperature distribution validation study fast and easily.

WHAT IS A THERMAL MAPPING PROTOCOL TEMPLATE?

It is a downloadable document ready to use and customize to handle your validation’s needs of temperature monitoring and distribution in your areas and equipment according to the 21 CFR Part 820.70 and 21 CFR Part 211.110 Production and Process Controls.  This document contains 20 pages and is fully editable in MS Word and contains copyright information only authorized to use within your company site.  Another distribution outside your company is prohibited.

 

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PROTOCOL TEMPLATE DESCRIPTION

This procedure provides instructions for the creation and implementation of the validation activities. To download a free validation protocol template sample in .pdf format, click here.  

Here is the table of contents of this validation protocol template.

CIQA Thermal Mapping Protocol Template - Full Version - Index Page

HOW TO AVOID MISTAKES PERFORMING A THERMAL MAPPING  VALIDATION STUDY.

  1. Identify the area to be validated.  Visit the area to evaluate where and how to place the temperature data loggers.
  2. Determine its size and dimensions. It is important to estimate the sampling locations and the total number of sensors and measuring instruments during the monitoring.
  3. Evaluate the materials of construction of the equipment or area, also determine the area classification or intended use.
  4. Determine the number of sampling locations and data loggers required to perform the validation study.
  5. Determine the temperature and % relative humidity range that is required by your process.
  6. Select the correct temperature data loggers appropriate to measure the temperature range necessary.
  7. Write a thermal mapping protocol.  In case you need to create or update your thermal mapping protocol, you can use a template protocol to accelerate the process to perform the validation study and monitoring.
    • To download a free sample of a thermal mapping protocol template in .pdf format, click here.  

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Moreover, soon you can use a Validation Management Software Application to handle all your qualification and validation documents from anywhere at any time.

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For more information about services to make the initial setup, configuration, and statistical summary reports with trending graphs, click here.

To rent temperature and humidity data loggers

To rent temperature and humidity data loggers

One of our data logger experts can set up, configure and bring to you the data loggers ready to use and be installed to collect information from your thermal mapping study.   At the end of your monitoring, you can send the data loggers back to us for data extraction, evaluation, and perform the statistical analysis and plotting with averages, maximums, and minimums.

brought to you by CIQA-thermal Mapping Distribution Studies

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. Rest assured of the safety or being in the right hands.

IF YOU HAVE ANY QUESTIONS ABOUT VALIDATION PROTOCOL TEMPLATES, FEEL FREE CONTACT US (Hablamos Español)

REFERENCES:

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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