A Novel Design To Contained Transfer Of Drummed Materials Using A Disposable Manufacturing Approach

Everyday in one way or another, our industry has to deal with getting materials out of drums. Whether active pharmaceutical ingredients (APIs), intermediates, or excipients the issue of how you open a drum and transfer that powder into a vessel is an on-going problem.

Until today, operators had to either donn personal protective equipment (PPE), rely on air extraction systems, or use rigid isolators when processing active ingredients from drums. With the first two of these approaches processing is performed in an open fashion.

This is opposed to a closed manner as being put forth by the ISPE Containment Community of Practice's Risk Based Manufacture of Pharmaceutical Products (Risk-MaPP) efforts which is addressing risk management for manufacturing highly hazardous compounds. Neither of these two "open" processes are a satisfactory solution to the on-going industry call for the use of Engineered Controls and the guidelines set forth in industry regulations.

Rigid isolators have been used to meet this need in high end exposure areas in the past but, while they do provide a closed processing approach, they do not always meet the ergonomic needs seen in operators ranging from the 5th percentile female to the 95th percentile male. While isolators do have their place in the containment scheme, they also do not meet the needs of the ever growing trend of disposable manufacturing and the need to achieve the lowest possible total ownership cost. The reduced capital expenditures and reduced cleaning and cleaning validation costs of disposable manufacturing compare favourably in a comprehensive Economic Benefit Analysis of containment levels, capital costs and operational expenses.

The Drum Transfer System (DTS) described in this article has been validated in a variety of processes requiring the contained transfer of drummed materials in pharmaceutical applications. Processing operations described here include milling, subdividing, charging, and repackaging.

By thinking outside the "box", the myriad demands placed on pharmaceutical manufacturers including, but not limited to, capital and operational cost, speed to market, and safety can be addressed without compromise.