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 and maintains a high air quality.

Approach

The validation of isolators includes filter integrity testing, particulate monitoring and airflow checks.
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.
Our testing is comprehensive and designed to satisfy the requirements of US (FDA), UK (MHRA) and European regulatory authorities.

Experience

PEV staff are experienced in the validation of Isolators. We understand the requirement of the relevant standards and guidelines for all isolator types.
We are experienced in the validation of many manufactures of safety cabinets including Getinge, Envair LaCalene and ACE.