Cold Rooms and Stability Rooms / Chambers

Introduction

Cold Rooms and Stability Rooms / Chambers provide temporary or long term storage of pharmaceutical, biotechnological and biological products / samples.

Approach

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 for review and approval whilst still ensuring compliance with GMP is demonstrated.

To confirm cGMP compliance full documentation and construction checks will be carried out. Empty and loaded chamber thermal mapping to confirm the correct storage conditions are achieved.   All critical components will be recorded to ensure a validated state can be maintained.  

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

We are conversant with current industry standards and guidelines, including ICH Harmonised Tripartite Guideline 'Stability Testing of New Drug Substances and Products Q1A(R2) and ICH Harmonised Tripartite Guideline 'Stability Testing of Biotechnological/Biological Products Q5C

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

Either a calibrated humidity sensor is connected to the Validator 2000® and calibration verification performed on site using traceable salts, or alternatively a stand alone calibrated humidity logger is used.

Experience

PEV have experience of validating Vindon, Binder, CRC and many other manufacturers of Cold Rooms and Stability Rooms / Chambers.