Validation Case Study: Blood and Plasma

Our client operates regional plasma donation centers. Plasma is used to create medicine that treats chronic illnesses, including immune disorders, liver disease, bleeding disorders, and cancer. There simply is not enough plasma for everyone who needs it, and our client aims to change that - one donation at a time.

Our client expanded their network with seven new blood plasma donation centers to meet the increasing demand for plasma collection and storage. Each site required plasma freezers capable of maintaining stringent temperature requirements to ensure product integrity and compliance with regulatory standards. To prepare these sites for inspection readiness, all units had to be fully qualified prior to operational use.

TRANSCAT’s Validation team was tasked with completing the Installation, Operational, and Performance Qualification (IOPQ) of multiple large-capacity plasma freezers across seven centers. The work needed to be standardized yet executed under site-specific conditions, while ensuring compliance with regulatory guidelines and meeting aggressive timelines for center openings.

TRANSCAT’s onsite engineers and support staff executed full qualification protocols for the Plasma Freezers, including:

• Installation Qualification (IQ):
  Verified freezer installation, mechanical integrity, environmental conditions, equipment identification, and calibration/preventive maintenance schedules.
• Operational Qualification (OQ):
  Confirmed that control systems, alarms, temperature settings, and monitoring components functioned in accordance with manufacturer and protocol requirements.
• Performance Qualification (PQ):
  Conducted comprehensive freezer performance testing, including:
  • 12-hour empty chamber mapping at -40°C
  • 24-hour loaded chamber mapping at -40°C
  • Daily packing and bi-weekly shipping movement studies to simulate operational use
  • Core freeze study ensuring plasma samples cooled to ≤ -25°C within 12 hours
    
  • Thermocouple calibration and verification for data integrity

Key Project Details

Schedule:

• Completed IOPQ across all seven plasma donation centers within the client’s aggressive startup timeline.
• Aligned validation activities with center opening schedules to prevent delays in site readiness.

Quality:

• Verified freezer performance met strict GMP/GLP requirements for plasma storage (≤ -25°C).
• Executed comprehensive performance studies (empty, loaded, movement, and core freeze) to confirm compliance.
• Ensured all deviations were documented, reviewed, and resolved in accordance with client and regulatory expectations.

Electronic Delivery:

• Protocols executed digitally using Transcat’s validated Valgenesis platform (21 CFR Part 11 compliant).
• Enabled real-time collaboration, deviation management, and audit trail capture.
• Delivered final Qualification Packages electronically via a single PDF file using Transcat’s secure C3 portal, ensuring 24/7 access for downloading the documentation and serving as a backup repository for document retention.

Through successful completion of IOPQs across all seven sites, the plasma freezers were demonstrated to consistently achieve and maintain the required operating specifications. The client is now audit-ready, with documented evidence that the freezers are installed, operate, and perform to standards necessary for GMP/GLP plasma storage. This ensures the centers are prepared to safely and compliantly store plasma to support growing donation and supply chain needs.