<aside> 💡 **Here's how I recommend collecting the appropriate information when developing your Temperature Mapping Protocols.
Remember: The success in completing your temperature mapping qualification is all in how you manage it.
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This will serve as your firm foundation for generation and development for any of your qualification protocols.
It is my goal with this digital product offering to provide some foundational understanding to a successful qualification approach and protocol start.
I know this may be a lengthy note, but I wanted to provide you as much content as you may need. Please let me know if I missed anything - we can always stand to improve.
Remember: It’s progress not perfection we seek.
Ok, lets get started.
Here is where we will uncover the sequence of steps when developing and executing a temperature-controlled chamber.
Download Sequence of Steps below:
Sequence of steps for temp-controlled units.pdf
<aside> 💡 💁♂️ 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.
Need help? Just let me know.
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URS Generation:
IQ/OQ/PQ Generation:
Protocol Development:
These are the qualification activities you'll see during the protocol development and execution phase.
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.
Here is a list of what a basic temperature-controlled chamber qualification (temperature mapping protocol) should contain:
The cover page of your document should typically incorporate an ‘approval block’ listing the author of the document and the people responsible for the piece of equipment and a description of the document in the header.
The second page of the document should include a table of contents for what the body of the document will include.
Section 1: Purpose
Section 2: Scope
Section 3: Responsibilities
Section 4: Equipment Description
Section 5: Qualification Procedure or Approach to Qualification
Section 6: Installation Qualification
👉 Study Participant Signature Verification
👉 Standard Operating Procedure Verification
👉 Equipment and Utility Installation Verification
👉 Documentation and Drawings Verification
👉 Calibration Status of Critical Instruments
👉 Test Instrument Calibration Information
👉 Installation Check
Section 7: Operational Qualification
👉 Operational Controls and Setpoint Verification
👉 Alarm Verification (High and Low Temperature Alarm - BMS and Local)
👉 24 hour Empty Chamber Temperature Mapping Study (empty condition without any load inside the storage area)
👉 Open Door Verification Test
👉 Power Loss Temperature Test
Section 8: Performance Qualification
👉 24 hour Loaded Chamber Temperature Mapping Study (loaded condition should mimic a fully loaded storage space - or at least 60-70% loaded condition inside the storage area).
<aside> 💡 Loaded chamber testing is conducted to provide documented verification that the system performs per its intended use when operated under routine challenged conditions and that the unit meets the pre-approved criteria.
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IQ/OQ/PQ Summary Report
👉 When all installation, operational & performance testing has been completed, all exceptional conditions (if any) have been documented and resolved and all acceptance criteria have been met, the completed IQ/OQ/PQ protocol shall be circulated for post-execution approval.
<aside> 💡 🏁 Once the IQ/OQ/PQ has been approved by all appropriate departments, the temperature mapping qualification of the CTU shall be considered completed.
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If you made it this far, congratulations. You’re taking the future of generating Temperature Mapping Protocols into your own hands and actually doing something about it. You should be proud.
👉 I would like to introduce you to the idea of a Prerequisite Form.
What is a Prerequisite Form?
The prerequisite form is a tool I created that is emailed to our clients or the owners of the equipment to capture all pertinent information that ensures we generate documentation in the most effective way possible.
The prerequisite form is an easy to fill out Adobe PDF form.
We all know that when trying to generate a document or even when executing a document - unfulfilled prerequisites are a major cause of downtimes and wasted money. 👎
Therefore my form enables us to cut down costs and is essential to delivery of a thorough temperature mapping protocol. 👍
Without further ado - here is what you paid good money to see 👇 👇 👇
Complete the following form sections to successfully initiate protocol development.
Download Prerequisite Form below:
👉 Section 1: Customer Contact Information
👉 Section 2: Roles for Protocol Review and Approval
👉 Section 3: General Information (Equipment ID, Manufacturer, M/N, S/N, etc.)
👉 Section 4: Specifications (setpoints)
👉 Section 5: Calibration (calibration date, due date)
👉 Section 6: Qualification Information (protocol number, SOP no., etc.)
👉 Section 7: Documentation Upload (pertinent files for development, e.g. manuals, templates, user manuals)
👉 Section 8: Scheduling (execution start, completion date)
Congrats! After your customer or equipment owner fills out the easy adobe pdf form and 📩 returns it to you - it’s time to begin drafting your protocol (see the sequence of steps above).