Practical containment – how to address and solve HAPI containment challenges
TORSTEN BELGER
ProSys Containment & Sampling Technology, IDA Business Park, Carrigtohill, Co. Cork, Republic of Ireland
Abstract
The highly active pharmaceutical ingredients (HAPI’s) sector is the fastest growing segment within the pharmaceutical industry globally. The toxicity levels of HAPI compounds are increasing constantly. This brings about new challenges when handling these compounds during manufacturing. This article provides an introduction to current techniques used for addressing these challenges. This article presents the containment engineer’s point of view and attempts to translate his experience into an assessment of the efficacy of different approaches to realizing containment. Different containment techniques are explored and assessed within the article with a view to give some guidance to the successful interaction between users and containment engineers.
Increasingly potent drugs have made it a necessity for the pharmaceutical industry to implement dramatic changes in the plant design and operating procedures to ensure adequate containment. Torsten Belger of ProSys Containment & Sampling Technology shows some of the solutions to a universal problem faced by the drug companies.
Currently some 10% of Active Pharmaceutical Ingredients (API) being manufactured are classified as Highly Active Pharmaceutical Ingredients (HAPI). It is estimated that the Compound Annual Growth Rate (CAGR) of HAPI’s within the global pharmaceutical market will be at 8.4% to 2015 (1). As a result of this, there is a “class” of pharmaceutical manufacturing facilities, often referred to as Highly Active Pharmaceutical Ingredient (HAPI) facilities needing to be developed to meet the specific challenges associated with the handling of such compounds. The handling of HAPI affects in a much greater way than anticipated the designs and “norms” that have been developed for API facilities.
With the development of new drugs there has been a recognised trend of increased potency, which has resulted in the need to implement dramatic chan ...
