Freeze Dryers

Introduction

The preferred method of sterilizing freeze dryers is through the use of moist steam under pressure.
This Sterilisation-In-Place (SIP) process facilitates the sterilizing of not only the chamber, but also the condenser and piping. Providing evidence of reliable and consistent steam sterilization through effective validation is a universal expectation.

An even temperature distribution is required across the internal shelves during production for homogenous drying of the load. The demonstration of uniform shelf temperatures is an essential part of freeze dryer validation.

Approach

We measure temperature throughout the full working volume during SIP paying particular attention to potential dead legs and cold spots.

We perform shelf mapping across the full process temperature range and whilst under vacuum as appropriate.

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

We are experienced in the qualification of freeze dryers ranging from small free standing units designed for R & D purposes, to large scale production items.

We have experience with BOC Edwards, Usifroid and Telstar freeze dryers.

We can provide operational resource and assistance with User Requirement Specifications (URS), 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.