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Protocol · VAL-P03

Thermal Mapping Protocol - Stability Chamber and Incubator

Empty and loaded mapping of chambers, incubators, fridges and freezers.

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Purpose

To define the method for mapping the temperature (and humidity where applicable) distribution within stability chambers, incubators, ovens, pharmaceutical refrigerators and freezers, ultra-low freezers and controlled-temperature cabinets, as part of operational and performance qualification and periodic requalification, to demonstrate uniformity and stability within the specified tolerances throughout the usable volume.

What is inside

14 sections, about 3 pages when printed.

  1. 1. Purpose
  2. 2. Scope
  3. 3. Responsibilities
  4. 4. References
  5. 5. Definitions
  6. 6. Prerequisites
  7. 7. Acceptance criteria
  8. 8. Study design
  9. 9. Execution
  10. 10. Data analysis
  11. 11. Outcome
  12. Deviations
  13. Data integrity
  14. Report

How to complete it

  1. 1.Verify, synchronise and configure loggers (VAL-F08); record equipment identity, set points, controller and alarm settings, load and exclusion zones.
  2. 2.Place sensors per the diagram; photograph; complete VAL-F01; close the door and record the start time.
  3. 3.Do not open the door during the steady-state period. Record any alarms or events.
  4. 4.Perform the door-opening and power-interruption challenges at the planned times; record times and observations, including alarm activation (VAL-P08).
  5. 5.Retrieve loggers, download raw data unaltered, post-verify loggers, complete VAL-F08.
  6. 6.Analyse per section 10; record deviations (VAL-F09).

Before you use it

  • Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
  • Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
  • Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
  • Record the document in your own document register and set its review date.

Related documents

This is an original template published by ValiTrac. It does not reproduce the text of ISO/IEC 17025 or of any accreditation body publication, and it does not by itself confer or guarantee accreditation. Customise, review and approve it before use.