Autoclave Validation

Introduction

Moist heat sterilization remains the method of choice for products and equipment that are not adversely affected by the application of heat and moisture.

The demonstration of reliable and consistent steam sterilization through effective validation is a universal expectation.

Approach

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

We are conversant with current industry standards and guidelines, including BSEN285, ISO17665-1, PDA Technical Report No 1 and HTM2010.

We understand the difference between porous and fluid load sterilization and tailor our approach accordingly.

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

Experience

We are able to assist in the qualification of GMP, discard and high security (CL4) autoclaves.

Our staff are experienced in the validation of saturated steam, steam/air mix, high pressure water and water spray autoclaves.

We have experience with Fedegari, Getinge, Steris, SAL, LTE, Matachana, GE, Celester, Statim, Priorclave and Boxer autoclaves.

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.