Efficient temperature mappings for pharma

Discuss your needs with our validation specialists to pinpoint the ideal equipment amount and type for your specific study, be it stability studies or stress tests.

You receive a mapping kit containing everything you need. The kit contains:

• Calibrated, wireless data loggers compliant with GMP guidelines.
• Access to specialized validation software ensuring data integrity
• 4G router including SIM card

Create test plans and define data logger locations in the adjoining software. Need a hand? Our team specializes in risk mitigation and can guide you.

Place the loggers, plug the router into power, and connect all loggers with just one click.

The wireless data loggers will now automatically send data to the validation software allowing you to track the process in real-time and act on any issues right away.

The software provides various tools for you to analyze data efficiently.

“With the audit trail, it is easy to process a non-conformity or prove that everything is within set parameters, so we can have the report ready in compliance with GMP requirements.“

Dora Adanic, Chief Operating Officer at Genera Research Ltd.

After wrapping up your study, all you need to do is return the kit to us using the return label. We will then perform an exit calibration on the equipment, and once that is done, you can access the calibration certificate directly in the software.

Compliance rated high by Novo Nordisk-

Novo Nordisk audited our temperature monitoring solution and awarded it a “High” compliance rating.

“Eupry Aps provided enough documentation to conclude that procedures and efficient controls to ensure compliance are in place and well-functioning as intended in all key areas/processes, and that management and employees displayed strong understanding and positive attitude in regard to compliance,”

ISO AUDIT REPORT by Novo Nordisk, June 2023

FDA 21 CFR Part 11 compliance made easy.

The system has a specialized 21 CFR Part 11 module and makes it simple to comply with the regulation.

• Fully validated system
• Digitally sign changes
• Export audit logs ** And much more.**

Simple calibration without downtime.

No more worrying about (inefficient) calibration.

Our patented technology reshapes the way data logger calibrations are handled to greatly simplify the process.

New calibrated sensors are sent when you need them to be replaced in seconds. Data is automatically merged and certificates are stored in the software.

No extra loggers, no downtime, and no fragmented data.

Choose between ISO 17025 accredited or traceable 3-point calibration.

The calibration is included in the service with no extra costs.

“Particularly convenient is the automated calibration process where external calibrated sensors are replaced with new calibrated ones automatically,“

Eric Clausen, Distribution Manager at Freja

IT-validated compliance software your IT department will love.

The monitoring software is fully validated to ensure that the software meets pharma industry standards and compliance requirements, such as 21 CFR Part 11 and EMA Annex 11, reducing the risk of costly errors or data integrity issues.

IQ OQ Qualification protocol included.

The included Qualification Protocol helps you achieve GxP compliance with a custom-designed process for temperature monitoring.

This ensures:

• proper installation of the temperature monitoring system.
• correct configuration of all settings.
• effective procedures for managing alarms and deviations.

Secure storage of all your data.

Data security is handled according to ISO 27001 and Eudralex Vol. 4 Annex 11 Framework standards. All data is encrypted using AES and stored with continual backup procedures for up to five years.

Safe storage of personal data.

Personal data is handled according to CCPA and GDPR standards, providing an extra layer of assurance for your data's security. Given the stringent regulatory landscape in the pharmaceutical industry, the need for compliant data handling is particularly high, which is why our service is engineered to meet the highest standards, supporting your compliance.

We recommend our standard data loggers calibrated to ISO 17025 for temperatures between -30 and +50°C. Typically, 9 or 15 loggers placed in a grid do the trick for a standard fridge.

“Even small fluctuations in our freezer temperatures can have an impact on the quality of our samples. Eupry gives us trustworthy insights into this. This is essential in our work for making cancer vaccines real.”

Jennifer Bintz, Research Technician at InProTher

For the world of -80°C and below, our specialized external probes can be mounted through a service port or between the door and rubber gasket, thanks to their flat silicone cable making sure no unwanted openings are created eliminating deviations.

Typically, 15 loggers and sensors are sufficient. Each sensor comes with a 3-point calibration as per ISO 17025 standard, but additional calibration points can be added if needed.

Why it works:

• Specialized probes for extreme cold
• Easy mounting options through doors and lids
• ISO 17025-accredited calibration you can trust

For ambient storage areas with temperatures ranging from 15°C to 25°C, we recommend our standard data loggers – usually with sensors calibrated to three points in our ISO 17025-accredited lab.

The number of data loggers needed varies based on your storage size. A small room might require 15 to 30 loggers, while a larger warehouse could need over 300. Our in-house quality department can assist in assessing floor plans and defining the exact number of sensors for your needs.

All data loggers follow a naming convention to make it easier for you to locate specific devices in larger areas.

Why it works:

• Tailored recommendations based on your facility
• Custom logger counts based on space
• Consistent naming for easy identification

Our standard data loggers with ISO 17025 accreditation are also ideal for colder storage areas. The method follows ambient warehouse though the temperature variance might be higher in certain areas of the warehouse causing the need for further data loggers.

The number of data loggers needed varies based on your storage size. Our in-house quality department can assist in assessing floor plans and defining the exact number of sensors for your needs.

All data loggers follow a naming convention to make it easier for you to locate specific devices in larger areas.

Why it works:

• Tailored recommendations based on your facility
• Custom logger counts based on space
• Consistent naming for easy identification

Containers pose unique challenges because of fluctuating outdoor conditions and the question of connection.

Utilize the same equipment as for warehouse storage but include consideration about changing outside conditions when determining amount and placement (we can help you here). Battery-driven 4G router fixes any issues with connectivity.

The number of data loggers needed varies based on your storage size. Our in-house quality department can assist in assessing floor plans and defining the exact number of sensors for your needs.

Why it works:

• Durable for on-the-road conditions
• Tailored recommendations based on your facility
• Custom logger counts based on space