An all natural sweetener manufacturer had been supplying a major soft drink company was asked to provide a granular version of their super sweetener. Previously the sweetener manufacturer had contacted a contract manufacturer that was able to utilize a low-density-high-shear wet agglomeration process to produce a granulated product. The product produced had some solubility issues, only provided a 50% on specification first pass yield, and had some significant system losses that could not be recovered. In addition some of the off specification material had to be returned to the sweetener’s manufacturing facility for reprocessing.
In September 2009 CGI was contacted by the sweetener manufacturer to determine if we could provide fast track granulation process development and large scale production services under cGMP conditions. Based on our past experience with NutraSweet®, stevia based sweeteners, and caffeine CGI was confident that we could provide the level of service required. The customer arrived at our site within a few days of our initial conversation with the following requirements:
§ Material had to be relatively non-friable
§ The granules had to meet a specific dissolution rate
§ The proposed granule particle size range was -20 USS mesh +80 USS mesh
§ The granulation process had to be easily scaleable from lab to production equipment
§ The CGI facility would have to be audited and approved for production within a month.
§ 2000 kg test run under cGMP conditions would have to be completed within two weeks
§ 150 metric ton campaign would have to be completed by year end
During the initial visit we processed a laboratory scale sample and determined the sweetener was a good candidate for roll compaction granulation and that vacuum deaeration of the powder would have the potential to increase the production rate.
At this point we asked the question ‘Why do you want the particle size to be -20 USS mesh +80 USS mesh?’ Our customer indicated that was the particle size range their customer had requested. Having produced granulated NutraSweet® and caffeine for the soft drink industry we immediately recognized that the particle size specification given to our customer was the particle size typically required for NutraSweet®. NutraSweet® has very poor dissolution properties in water; therefore, the granules must be relatively small to achieve required dissolution rates. On the other hand, caffeine has relatively good dissolution rates in water; therefore, soft drink manufacturers will allow particle size ranges of -10 USS mesh to +40 USS mesh. -10 USS mesh + 40 USS mesh samples of the super sweetener were produced and found to provide adequate dissolution rates. The ability to granulate the sweetener to a larger particle size range will result in a faster production rate and a less expensive production cost. By end of our customer’s initial visit CGI had determined:
§ The sweetener could be roll compaction granulated at a production scale
§ The granule particle size range could be significantly increased to increase production rate and lower processing costs
§ We could meet the aggressive time line our customer required
CGI completed the initial 2,000 kg as required and the 150 metric ton production campaign 17 days ahead of schedule. All material was produced under cGMP conditions and all material met specification. The 150 metric ton production campaign resulted in total unaccounted losses and floor sweeps of 57 kgs.
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