Dry Heat Oven and Tunnel Validation

Introduction

Dry heat remains the method of choice for depyrogenation of equipment, where the items are not adversely affected by the application of heat.

Dry heat sterilization is used for the sterilization of equipment and product which might not be adequately penetrated by steam or is damaged by moisture.

Approach

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

We understand the importance of uniform airflow, heat distribution and load configurations and are able to advise accordingly.

We perform particle counting with equipment at production temperature and throughout the complete cycle in order to ascertain the true environment classification and the effect of heating and cooling on oven recirculation filters.

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

Experience

Our staff are experienced in the validation of both sterilization and depyrogenation ovens and tunnels.

We have experience with Fedegari, LTE, Lytzen and Ehret Ovens, and Bausch & Strobel, Bosch and BOC Edwards Tunnels.

We can help with the generation of User Requirement Specifications (URS), perform Design Qualification (DQ) and Validation Reviews.

We perform Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Re-qualification on clients behalf.