Accentus crystallisation system world first
system promises to revolutionise the way crystals are processed in
pharmaceutical manufacturing.
The C3 technology, developed by >Accentus, uses the power of ultrasound to control the crystallisation process and efficiently produce high purity microcrystalline chemicals, in the form of intermediates, excipients, active pharmaceutical ingredients (APIs), binders, sugars or colorants.
The use of ultrasound in this application was previously considered impossible to operate on a large processing scale, as the engineering expertise and equipment has not been available until now.
"We have solved the engineering problems involved with the upscale of this technology to provide the ultimate chemical processing equipment for pharmaceutical industry," David Hipkiss, general manager, C3 Technology, Accentus, told In-PharmaTechnologist.com.
There are no crystallisation methods within the pharmaceutical industry to rival this technology and the market is wide open for Accentus to capitalise.
"Launching this technology into the pharmaceutical manufacturing market is fundamental to our business plan and we expect it to generate significant sales and licensing revenue," said Hipkiss.
"There is no reason why this equipment will not become standard within the industry," he said.
Current crystallisation methods involve uncontrolled, random, multi-step processes that often result in wide variations in crystal size and quality, and require extra processing to achieve a product that will meet quality-control standards.
Almost all chemical processes utilise at least one crystallisation step, either as the key separation mechanism or final polish filtration.
Crystallisation has been described as one of the most difficult unit operations to control, irrespective of whether the process utilises cooling, evaporation, drown-out or pH shift.
Crystallisation is a two-step process, involving a nucleation step, which then gives rise to a site for a crystal form.
Sonocrystallisation uses ultrasound to greatly enhance crystal formation by providing better control of nucleation and significantly increasing the number of nucleation events, compared to current methods available.
The C3 technology is currently already being used on a commercial scale with in the alumina processing industry, having demonstrated its robustness in a long-term industrial process environment during a 10-month pilot program.
It is now undergoing final-stage validation trials for API production with an undisclosed pharmaceutical manufacturing company. Accentus hopes it will be commercially available for the pharmaceutical industry by the end of the first quarter 2006.
The equipment has is already validated across scale in GMP environments and importantly has recently been certified to ATEX ("explosion proofing") standards, allowing the technology to be evaluated at scale within a range of flammable solvent environments.
C3 technology can be used in in-line continuous flow mode, or batch mode for in-situ generation of seed crystals using the process mixture itself as the source for the seeds.
A typical explosion-proof system for a 2000L crystalliser is expected to cost around £150,000 excluding licensing fees.
