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

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

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 BSEN285:2006, ISO17665-1, PDA Technical Report No 1:2007, HTM2010.

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 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.