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

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.

We are conversant with current industry standards and guidelines. Our testing is comprehensive and designed to satisfy the requirements of US (FDA), UK (MHRA) and European regulatory authorities.

Experience

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

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

We can provide operational resource and assistance with the generation of User Requirement Specifications (URS), perform Design Qualification/Reviews (DQ), Factory Acceptance Testing (FAT), Site Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Re-qualification and Validation Reviews.