03/15/2018
ACHEMA 2018: Containment in Process Engineering
A paradigm change in solids production is underway in the chemical and pharmaceutical industries. The trend to increased specialization and higher-potency active ingredients creates the need for hermetically sealed process flows. Government regulations are also becoming stricter. To an increasing extent, the production process will have to be designed as a containment system.
No data - no market. This brief dictum from Brussels is a cause for serious concern at many companies in the process industry. It all stems from the EU REACH directive which requires prior registration for every substance produced or imported in volumes of 1 t/a or more. As marketing volumes increase, so too does the amount of data which a company must submit. This has a direct impact on the cost of the toxicological testing which is required. Testing costs an estimated 13,000 euros for volumes up to 1 t/a, but that figure can rise to more than 900,000 euros for volumes of 1,000 metric tonnes a year or more. Expensive as it is, registration is not some sort of modern-day sale of indulgences. It is actually only the first step. ECHA or a national regulatory authority then reviews the documentation which has been submitted.
The EU would prefer that substitutes are found for hazardous substances. Where this is not possible, plant operators must prove that they can safely handle highly active substances. A look at the statistics shows that more than just a few companies are effected by these policies. More than 50% of all NCEs (new chemical entities) are considered to be potent compounds (OEL