Cryogenic Storage/Controlled Rate Freezers

Performance Validation has extensive experience with cryogenic storage and controlled rate freezer qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries.  These projects included mapping studies using PV’s own inventory of Kaye Validators and thermocouples.

Performance Validation resources have expertise with calibrating thermocouples in and mapping of liquid nitrogen storage applications and product load and freezing profile development for controlled rate freezers.  A summary of the types of recent projects completed are identified below:

• Completed qualification (IQ/OQ/PQ) for a new controlled rate freezer, including engineering studies to determine the optimum vial freezing profile for a large pharmaceutical manufacturer central cell bank facility.
• Completed two liquid nitrogen vial storage dewar qualifications for an animal health manufacturer cell culture lab.
• Completed an engineering study to verify cryo vessel storage temperatures during permanent monitoring system RTD thaw for a large pharmaceutical manufacturer central cell bank facility.
• Completed a walk-in freezer qualification for a plasma processing/storage facility.
• Completed a cryo storage vessel qualification (IQ/OQ/PQ) for a large pharmaceutical manufacturer central cell bank facility.

For additional information on cryogenic storage mapping and controlled rate freezing, contact:

Neil Enlow

Principal Validation Engineer

Performance Validation, Inc.

Cell: (317) 341-2819