Mapping of 2 Incubators Using Wireless Dataloggers

Project Scope:

  • Validate 2 incubators
  • Fast turn-around, with minimum on-site time
  • Customer-designed protocol
  • Masy Quality Department reviews all documents

Personnel:

  • 1 Validation Project Leader
  • 1 Validation Technician
  • 1 Quality Review Specialist

Equipment:

  • 2 PCs with DataTrace™ software and base stations
  • 32 DataTrace™ wireless dataloggers

Results:

  • 12 days total, including 3 days on-site
  • Final billing under quote / purchase order

Project Summary:

Masy BioServices successfully validated two incubators, meeting the customer’s need for quick completion.

Due to the depth of trained Masy personnel and available inventory, Masy was able to accommodate this immediate request within the customer’s requirements. The field work, including project preparation and post-project wrap-up tasks, was completed in 5 days, including only 3 days on-site. Final reports were completed, reviewed, and delivered 7 days following completion of the on-site work.

This project required the use of wireless transmitting dataloggers placed within a clean room environment. Masy chose the DataTrace™ wireless datalogging package use to their ease-of-use and reliability. The incubators were validated using a 100% load of various customer-specified, sterilized test items. Each incubator was validated to a different temperature setpoint.

All work was completed and final validation reports were submitted within the customer’s requirements. The customer found no errors in our documentation.

This customer continues to call Masy regularly for validation projects. 
 

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