Validation Services

PARAMETER PROVIDES TURN-KEY, COST EFFECTIVE SOLUTIONS FOR YOUR VALIDATION NEEDS

 

Stability Chamber Validation and Temperature Mapping Service

Parameter has extensive experience in the development and execution of industry-proven stability chamber validation protocols. Parameter can provide and execute stability chamber validation protocols such as Installation, Operational and Performance Qualification.

All temperature data is collected using a Rotronic HW4 Mapping System and digital Rotronic HC2 dual Temperature and Humidity sensors, allowing for temperature and humidity measurements at each mapped point within the chamber.   All test equipment calibration is NIST traceable.

DOCUMENTATION

Parameter provides a complete document package tailored to your needs with each mapping study.  We can produce a complete mapping protocol for you, or follow a protocol that you have already created.  If you don’t need a full protocol for your mapping study, we can provide a basic validation plan prior to performing the study to specify the mapping details.

Regardless of the level of documentation you choose, after the mapping study has been completed you will be provided a clear comprehensive summary of the results.

Document Package results include:

  • Minimum, Maximum and Average Statistics
  • Mean Kinetic Temperature calculations
  • Detailed graphs
  • Test data
  • Deviations
  • The executed protocol
  • Test equipment calibration data with NIST-traceable calibration certificates.

Chamber Mapping studies include:

  • IQ/OQ/PQ
  • Empty Chamber Mapping
  • Full / Loaded Chamber Mapping
  • Simulated Power Outage
  • Open Door Recovery
  • Alarm Testing
  • Single and Multi-point Conditions
  • Calibration Verification

Once execution is complete, a validation report package is carefully prepared, reviewed and submitted for client approval.

Our Validation Engineers have extensive experience with temperature and humidity stability chambers and can provide you with the high quality service that will assure sample integrity and satisfy the most stringent regulatory requirements. Our ultimate goal is to leave you with the peace of mind that your company’s validation requirements are being met.

Chamber Graphs

These graphs show validation data performed on a large walk-in room, once while empty and again while full. Each color represents a different sensor located throughout the room. Notice the standard deviation rates for the entire data set represented on the right of the graphs, indicating that the walk-in room is being controlled very tightly throughout the validation cycles

Empty Chamber
Full Chamber