JAMES BALL1, CYRIL MOUNIER2
1. Senior Occupational Hygiene Consultant for SafeBridge Europe
2. Solution owner – Pharmaceutical application specialist for Getinge Life Science France

Abstract

To assess the containment performance of the DPTE® Alpha port, a suitable and easily repeatable task was required to challenge the device. This was achieved by subjecting an active pharmaceutical ingredient (API) isolator chamber (which housed the DPTE® Alpha port on the right wall) to an internal airborne concentration of a surrogate powder (acetaminophen). A commonly performed task within the pharmaceutical industry was chosen to accomplish this, specifically transferring a small quantity (500 g) of the surrogate powder, from one container to another. The containment performance of DPTE® Alpha ports has been reliably assessed and the data indicates their suitability as contained transfer devices when handling potent and highly potent pharmaceuticals.

INTRODUCTION: ISOLATORS AND TRANSFER SYSTEMS FOR HANDLING APIs
Within the pharmaceutical and biopharmaceutical manufacturing space, isolators are often the preferred engineering solution used to allow potent and highly potent active pharmaceutical ingredients (APIs) to be handled safely. These isolators are built with the sole purpose of protecting the operator by providing a reliable barrier between the person and the hazard. The containment performance of well-designed isolators has been shown to be in the low nanogram/metre cubed range (airborne concentration outside the isolator) and therefore these devices are well suited for protecting operators from exposure to potent and highly potent APIs. Within the pharmaceutical industry it is generally accepted that a potent API has an occupational exposure limit (OEL) at or below 10 μg/m3 and highly potent API as having an OEL below 1 μg/m3 (2).

Pharmaceutical grade isolators traditionally employ a negative pressure interior chamber to improve the containment of APIs. This feature is particularly advantageous in enhancing the integrity of the seals between the metal frame and glass w ...