Isolators

Introduction

Flexible film and rigid isolators are becoming the preferred method for the manufacturing of sterile pharmaceuticals.  They provide a physical barrier to protect both the product and the operator.

Unless containment is required isolators are kept at positive pressure to ensure only filtered air enters the chamber in order to maintain the required air quality.

The validation of isolators requires filter integrity testing, particulate monitoring and airflow checks.

Approach

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

We perform integrity testing of the HEPA filters to ISO 14644 to insure the air quality entering the isolator.

We perform pressure decay tests to ensure the safety cabinet carcass is integral.

We measure the airflows within the cabinet to ensure a sufficient air change rate to maintain air quality.

We perform airflow visualisation to demonstrate there are no still air areas within the isolator.

We measure particle levels at the working area to demonstrate the air quality meets the required classification.

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 experienced in the validation of all types of isolators as manufactured by Getinge, Envair, LaCalene and ACE.

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.