Temperature Mapping Tools for compliant mapping and qualification

Introducing Temperature Mapping Tools for compliant temperature mapping and qualification.

Download our free, simple, and practical tools that are helping people like you develop, execute and approve successful temperature mapping studies and equipment qualifications (IQ, OQ, PQ).

🌟 Temperature Mapping eBook - Just added to the main bundle. 👍

This eBook is a must-have for anyone working with controlled temperature units. Learn more: https://temperaturemapping.gumroad.com/l/ebook

1. Qualification Sequence of Steps
   • Here is where you will uncover the qualification sequence of steps when developing and executing a protocol.
   • Installation Qualification (IQ) & test scripts
   • Operational Qualification (OQ) & test scripts
   • Performance Qualification (PQ) & test scripts
2. Prerequisite Form
   • Do you know the general questions one would have when beginning to draft qualification protocols?
   • 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. 👍
3. Validation In Progress Signage
   • Let's not forget to add the Validation In Progress sign to your CTU during Temperature Mapping.
4. Post Execution Validation Checklist Template
   • Here is something that may help some of you out in the field writing and/or reviewing documents. Take a look at this review checklist and see how it can be useful.
   • A self-review checklist is needed most of the time. So many times, people turn documents in without giving it a correct review. 
   • Use it yourself, email it out to people, modify as you see fit. Best to print it out or review it digitally and use it before you hand in protocols for review/approval.
5. CTU User Requirement Specification (URS) Template
   • The URS process should enable clear communication and management of the critical requirements of a system throughout its life cycle.
   • Requirements should be documented in a clear and precise manner, written such that they can be tested.
   • Take a look at the CTU template provided here to help get you started.
6. CTU Validation Protocol Template
   • For those of you that aim to comply with regulatory requirements there’s a continued emphasis by regulators on the need to perform temperature mapping on controlled temperature storage units.
   • Regulations also require that manufacturers in healthcare industries, pharmaceutical companies, and research laboratories use equipment, systems and processes that are up-to-date and fit for purpose.
   • A properly developed qualification protocol will help ensure that the equipment meets all of the documentation requirements and performs as expected. This includes ensuring that the temperature mapping study is carried out correctly.
   • Take a look at the CTU validation protocol provided here to help get you started.
7. Sensor Location Checklist Template
   • Industry guidance instructs us that when determining mapping locations, the potential storage location should also be considered along with the following:
     • Evaluating the size of the space
     • Identifying the airflow
     • Determining the usage of the space
   • Using a location checklist can aid in determining and provide the rational when selecting the mapping locations.
   • Please use the sensor location checklist provided here, as reference, when determining mapping locations.
8. Steam Quality Testing Report Template
   • The purpose of Steam Quality Testing (SQT) is to verify the steam supplied to the autoclave is of sufficient quality to perform effective steam sterilization according to European Union (EU) requirements, indicated in standards HTM 2012 & EN-285.
   • Take a look at the SQT Report provided here to help get you started.
9. Turnover Package (TOP) Template, plus a TOP Checklist
   • The purpose of this template is aimed at providing a guideline for the generation of Turnover Packages (TOP’s) for utilities, equipment and associated control systems.
   • TOP’s are a repository for equipment and system related documentation generated during commissioning. This procedure also provides a template for TOP checklists used during compilation of the TOP’s.
10. Incubator Operation and Maintenace SOP - Example
    • The purpose of this SOP sample is to provide you a starting point, an example for outlining the operation, maintenance, and calibration of your Controlled Temperature Chamber.

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-Nate

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