Fridges / Freezers / Ultra-Cold storage

Introduction

Where temporary or long term storage of pharmaceutical, biotechnological and biological products / samples is required, fridges, freezers and ultra cold freezers are used.

Approach

Our testing is comprehensive and designed to satisfy the requirements of US (FDA), UK (MHRA) and European regulatory authorities.

The simplicity of the equipment often allows combined IQ/OQ protocols or IQ/OQ/PQ protocols to be generated and performed. This significantly reduces the amount of documents requiring review and approval whilst still ensuring compliance with GMP.

We use distribution thermocouples located in free space to confirm the correct control settings and operation of the equipment.

We use penetration thermocouples located within the product container to verify the required storage conditions are maintained throughout the useable volume.

The ambient temperature is also monitored during testing to confirm the units are suitably located, according to the manufacturer's specification.

Detailed validation reports are compiled that contain all of the real-time data generated as well as a concise summary and clear conclusion.

Experience

PEV have experience of validating Sanyo, Dometic, Lab Impex, Thermo Electron, New Brunswick Scientific, Revco and many other manufacturers of fridges and freezers.

We can help with the generation of User Requirement Specifications (URS).

We perform Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Re-qualification on clients behalf.