Incubators

Introduction

Incubators provide a controlled environment for the incubation of microbiological media. Temperature, humidity and O2/CO2 are often controlled within the incubator chamber.

Approach

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

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.

For humidity measurement we use either a sensor connected directly to the Validator 2000 which is calibrated on site using traceable salts, or alternatively a stand alone certified humidity logger.

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 New Brunswick Scientific, Thermo Electron, Binder, Belco and many other manufacturers' incubators.

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

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