With an ever-increasing number of processing plants coming on stream worldwide to keep up with the rapidly expanding pharmaceutical and biotechnology industries, the focus on the release of volatile organic compounds (VOCs) into the atmosphere is coming under intense scrutiny by environmental authorities.
VOC is the common descriptor for a wide variety of hydrocarbon-containing chemicals. They are numerous, varied and ubiquitous, and the risks associated with them are aggravated by the fact that hazardous concentrations are usually very low and the health issues they can cause can be accumulative and slow to develop. The release of VOCs from industrial processes not only poses a direct potential hazard to human health, but their release also has more widespread environmentally damaging consequences including their carbon footprint, as well as the financial costs involved in their replacement.
IMPACT OF THE IED
The European Commission's Industrial Emissions Directive (IED) published in November 2010 standardizes the maximum emissions levels across a very broad range of industries throughout the European Union (EU). The IED reorganized seven existing and overlapping directives related to industrial emissions — including the Solvent Emissions Directive (SED) — into a single, clear and coherent legislative instrument. Its implications will be cascaded through national governments into local or provincial legislation of EU member countries and enforced by inspectors in their local authorities.
One of the main reasons for the recast of the Directive was an inadequate and incoherent application of “Best Available Techniques” (BAT) to optimize all-round environmental performance across the EU. Additionally, because the relevant provisions were spread across seven different legal instruments, it was deemed to place an unnecessary administrative burden on manufacturers.
Many primary industrial sectors in the EU are already well regulated in terms of emissions, but the aim of the IED is to harmonize and standardize how they are regulated and how BAT is utilized across the entire region by setting minimum emissions benchmarks and improving the quality and consistency of implementation.
The IED will describe how emissions control, measuring and monitoring should take place and will be driven by an increase in the use of BATs via revised “BAT Reference” (BREF) documents in order to obtain better consistency of implementation across the EU. The BAT approach is aimed at identifying and applying the best technology available worldwide and applying it as cost effectively as possible on an industrial scale to reduce emissions and achieve a high level of environmental protection. The BREF documents contain the maximum emissions values for many industries, from refining to pharmaceutical manufacture.
The IED principally focuses on 13 specific pollutants or polluting substances to air — among them NOx, SO2 and carbon monoxide — but also one category of particular relevance to plants involved in the manufacture of pharmaceutical ingredients: VOCs.
A major source of man-made VOCs is solvents. As with other VOCs, when solvents increase in temperature, as is often the case in production processes, they evaporate and enter the atmosphere where they can be damaging to the environment, create nuisance odors, potentially cause a variety of health problems. There are several different technologies to reduce or remove solvents from exhaust streams mainly involving destruction or recovery and reuse depending on the recovery value and concentration of the solvents.
One of the most effective ways — and a recognized BAT — to abate solvent vapors is to condense and capture them using liquid nitrogen as a cooling media in a process called low temperature or cryogenic condensation. Liquid nitrogen has tremendous cooling capacity, so when it is used to cool the condenser, VOC emissions can rapidly be reduced to very low levels. Subject to purity requirements, recovered solvents can sometimes then be reused in the industrial process.
BAT IN ACTION AT AESICA
Aesica is a leading UK-based contract manufacturer for formulated products and active pharmaceutical ingredients (APIs). Its products are used in the formulation of medications such as anti-inflammatories, analgesics and anti-depressants, among many others. Founded in 2004 and with approximately 1,300 employees, Aesica is a fast-growing company with a global footprint including operations spanning Europe, North America and Asia. It was purchased last year by Consort Medical Plc, though there are no plans for a name change at present.
The company is committed to being a good corporate citizen and holding itself to the highest standards of environmental management. It has been recognized with industry awards for its environmental performance, and as it continues to expand its portfolio, Aesica makes every effort to maintain or raise its emission control standards.