ICS Delivers Specialized Calibration for Medical Storage

Navigating Cleanroom Compliance and Extreme Cold: ICS Delivers Specialized Calibration for Medical Storage

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A medical manufacturing company required temperature and humidity calibration for their ultra-low freezers (as cold as -80°C), while meeting stringent regulatory compliance and cleanroom protocols.

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The Challenge

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Environments with regulatory mandates for accuracy

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Freezers calibrated at -80°C

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Required adherence to cleanroom sterilization protocols

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Needed integration with their internal monitoring system

The Opportunity

ICS had to innovate a method that balanced strict industry standards with the client’s internal processes. Objectives included:

Background (6)

Enable calibration at -80°C using custom probes

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Ensure sterilization and compliance with
cleanroom access procedures

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Allow data tracking across both ICS and client platforms

The Solution

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Procured a specialized probe for ultra-low temperature calibration

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Adopted cleanroom attire and sterilization standards

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Customized process workflow to align with client’s regulatory needs

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Integrated calibration results directly into the client’s system, along with ICS Live

Benefits

Met or exceeded regulatory requirements

Maintained cleanroom integrity

Enabled real-time monitoring through dual-system updates

Demonstrated technical flexibility and industry awareness

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Results

Layer 1 (4)

Accurate and compliant calibration for critical storage systems

Layer 2 (3)

Seamless integration into the client’s internal tracking system

Layer 3 (4)

Seamless integration into the client’s internal tracking system