Thermal Mapping & Validation Solutions
Thermal mapping involves documenting, executing, and evaluating the validation of temperature-controlled units (TCUs) and warehouses, crucial for safeguarding time and temperature-sensitive pharmaceutical products (TTSPP). Its primary goal is to ensure temperature and/or humidity levels within these controlled units adhere to required specifications.
INVOLVED TESTS
A full mapping approach of newly installed CTU is generally executed when the system is not yet in use. It consists of:
- Static empty chamber study with determination of hotspot and coldspot to determine monitoring sensor(s) placement
- Placement of the monitoring sensor(s)
- Static loaded chamber study
- Dynamic loaded chamber study consisting of door openings, power failure and power recovery test.
The duration of a study of a storage area influenced by the outer temperature is at least 7 days, the duration of a storage area not influenced by the outer temperature (e.g. refrigerator) is at least 24 hours. These periods may differ per customer.
Thermal mapping of temperature controlled warehouse
As an example, we shortly explain how a thermal mapping of temperature controlled warehouse is executed.
The validation of the warehouse (15°C – 25°C) will include temperature and/or humidity mappings performed during summer and winter conditions if the temperature of the ambient warehouse can be influenced by outside temperature.
Prior to the dataloggers placement, the following factors could contribute to the temperature variability in a warehouse:
- Size and Height of the warehouse
- HVAC locations
- Racks & shelving
- Doors & windows
- Weekly workflow variation (human factors and traffic patterns)
- Environmental impacts
- Areas where products are stored
To ensure that all above factors are taking into account, the floor plan of the warehouse should be used as a schematic diagram for the dataloggers placement. For smaller CTUs we usually work according to the ‘box model’, but as the systems gets bigger or more complex more loggers can be placed.
Why Choose Agidens?
The Agidens Team
At Agidens, we have a team of over 150 consultants who serve clients in long-term validation projects. Within this group we have a specialized team of around 30 Validation Engineers who are available for shorter, more scope driven projects regarding thermal validation studies.
Our Validation & Testing Engineers are fully trained in a variety of thermal mappings for example:
- Freezers (-80°C, -20°C, -196°C), Fridges, Incubators, Ambient and cooled warehouses
- Autoclaves, Dryheat ovens, SIP installations, Washer desinfectors
This list is not limited. If you have a request we provide you a fitted solution with an experienced validation engineer, the right testing equipment that complies to your company standards.
Specific expertise
In the aftermath of the COVID-19 outbreak, we have successfully validated more than 500 temperature-controlled units with attention on speed to market. This achievement is a result of our strategic deployment of both our skilled workforce, efficient planning and state-of-the-art temperature sensors. By synergizing specific mapping procedures and combining multiple mappings, we have unlocked a remarkable level of efficiency.
If timelines are critical Agidens can also support working out an out of place mapping strategy to speed up overall timelines.
With over 15 years of experience in the business, our SMEs have built up a remarkable expertise. If clients have a specific issue or question, they know who to contact. Our portfolio is filled with diverse projects, containing temperature mappings for extensive warehouses, meticulous assessments of tabletop freezers, and everything in between.
If you have 50 temperature-controlled units that require a validation within a short deadline, Agidens can make it work.
PROVEN EXPERTISE, DAY AFTER DAY
- Over 25 years of experience in thermal validation studies
- Qualification of over 500 CTUs
- We supported over 20 customers with thermal mappings
- Net Promotor Score of 8,125
- Our SMEs support in setting up a mapping approach, root cause analysis on deviations …
TAKE YOUR THERMAL MAPPING TO THE NEXT LEVEL
Do you like our approach? We would love to hear from you!
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