Pharmaceutical refrigerators

Pharmaceutical refrigerators – often called pharma fridges – are essential for storing medicines, vaccines, and biologics safely within +2 °C to +8 °C. However, in regulated industries, it is not enough simply to keep the right temperature. Compliance requires validation, monitoring, calibration, and thorough documentation. This guide explains what compliance means for pharmaceutical refrigerators and how to stay audit-ready without overloading your team.

Also read: Thermal compliance requirements for pharmaceutical refrigerators

What is a pharmaceutical refrigerator?

A pharmaceutical refrigerator is a temperature-controlled unit (TCU) designed specifically for storing medicines, vaccines, and biologics. Unlike domestic fridges, pharma fridges are built to meet GxP compliance needs, including stable temperature distribution, alarms, and audit-ready documentation.

Pharma refrigerators are used in many environments – from hospital pharmacies to biotech labs and global distribution warehouses. Each setting faces unique compliance challenges, but all must prove their fridges work as intended.

Also read: What is a temperature-controlled unit (TCU)? Key GxP terminology explained

What are the compliance requirements for pharmaceutical refrigerators?

Pharma refrigerators must meet strict regulatory standards to ensure medicines remain safe and effective. Guidelines such as EU GDP, GMP Annex 15, USP <1079>, and DIN 13277 set expectations for storage conditions, qualification, and monitoring.

Common compliance requirements include:

• Temperature range: Refrigerators must keep contents between +2 °C and +8 °C, with setpoints around 5 °C.
• Alarms and excursions: Alarms should trigger when limits are breached, and excursions must be logged and investigated.
• Qualification: Units must be qualified with IQ, OQ, and PQ protocols before use.
• Ongoing monitoring: Continuous temperature monitoring is required, with records stored for audits.

Also read: Guide: The key regulations for temperature compliance in GxP

How do you validate a pharmaceutical refrigerator?

Validation is the process of proving that a pharmaceutical refrigerator performs as intended. This involves installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

• Installation qualification (IQ): Verifies that the fridge is installed correctly, meets specifications, and includes required documentation.
• Operational qualification (OQ): Tests operational functions such as alarm performance, door openings, and power failure recovery.
• Performance qualification (PQ): Confirms the unit can maintain temperature under real-world loads with mapping studies.

Validation engineers often face bottlenecks due to resource constraints and repeated requalification. Using standardized digital protocols can speed up validation and reduce audit risk.

Also read: Guide: IQ, OQ, PQ for TCUs

What is temperature mapping for pharmaceutical refrigerators?

Temperature mapping demonstrates how temperatures are distributed inside a fridge. It identifies hot and cold spots and proves the unit maintains a stable environment under realistic conditions.

A typical mapping study includes:

• Sensor placement: Multiple calibrated loggers are placed in representative positions, including doors and corners. Learn more about placement of data loggers for mapping.
• Test conditions: Mapping is done with doors closed, during door openings, and sometimes with power failure simulations.
• Reporting: Data is analyzed, and deviations are explained with corrective actions if needed.

Mapping is often repeated after changes, moves, or repairs. Continuous mapping can reduce re-mapping needs by turning snapshots into ongoing compliance.

Also read: Pharmaceutical refrigerator mapping: How to plan, execute, and pass audits

How should pharmaceutical refrigerators be monitored?

Monitoring is critical for maintaining compliance between qualifications. GDP requires continuous monitoring of temperatures, with alarm systems to detect deviations and audit-ready reporting.

Monitoring best practices include:

• Continuous logging: Use calibrated data loggers or monitoring systems connected by Wi-Fi.
• Alarms and alerts: Configure high/low alarms and test them regularly.
• Audit trails: Records must be Part 11 compliant, with secure timestamps and no editing.
• Calibration: Loggers and probes should be calibrated to ISO 17025 standards.

Pharmacies and warehouses often face challenges with manual monitoring, delayed alarms, and scattered calibration certificates. A digital system with centralized visibility can solve these pains.

Also read: Temperature monitoring guidelines in GxP

Why does calibration matter for pharmaceutical refrigerators?

Calibration ensures that temperature probes and data loggers provide accurate readings. Without reliable calibration, even a fridge that seems compliant could fail an audit.

Key considerations include:

• Frequency: Calibration intervals are defined by risk and SOPs, often yearly.
• Standards: Calibration must be ISO 17025 accredited for auditor acceptance.
• Documentation: Certificates should be stored centrally and linked to specific probes.

Pssst.. Eupry’s automated calibration reduces idle time by allowing calibration directly at the site, saving QA teams from unnecessary downtime.

Also read: Temperature calibration services