BioMetrix
Services for the Life Sciences



Our Freezer Validation Services Include:
  • Protocols aimed at robust compliance
  • Use of NIST-traceable Kaye Validators and three-point premium sensor calibration prior to qualification activities and verification after qualification is complete
  • Empty & full chamber mapping to assess temperature distribution
  • Power loss recovery test and open door recovery studies
  • An audit-ready final document package
Freezer Validation

Biometrix can validate your freezer to the strictest of requirements, whether you are preparing for an FDA audit, or complying with 21 CFR Part 211 or ISO-13485

Each of our Validation Engineers has over ten years of field-service experience in executing FDA-compliant protocols, coupled with extensive training in current Good Manufacturing Practices (cGMP) and safety protocols

Our Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols reflect a customized approach aimed at delivering robust and efficient regulatory compliance coupled with the desired degree of confidence

We include our clients in the review, edit and approval cycles of all testing protocols

An array of high-performance premium calibrated thermocouples are used to qualify the operation and performance of your freezer. All test equipment is calibrated to NIST-traceable standards before and after your validation to ensure the utmost accuracy

Your audit-ready documentation package includes a summary report, completed protocol and detailed data with all requisite statistical calculations and attachments including calibration certificates

Our competitive pricing reflects our many years of experience coupled with our extensive library of hundreds of executed protocols, which we reference to expedite new document packages. This time-savings approach is gladly passed on to you as lower pricing. We also structure our hours on-site to not interfere with your peak activity periods, thus minimizing equipment down-time

Let's get started today! A quick call to our toll-free number 1-800-890-8909 will reach one of our experienced engineers with informative answers to your questions and same-day pricing (24 hours or less)

We look forward to being of service!

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  • Biometrix Corporation
  • 301 Edgewater Place, Suite 100
  • Wakefield, MA 01880
  • www.biometrix.com
  • Tel: (978) 338-5263