5


ISCA Iscaguard®


It can be used over a wide pH range, from 3.0 or lower, up to 8.0 and should be added during the cooling stage of any hot process.


Regulatory Status Iscaguard®


CMI is approved for use in the US (up to a


maximum of 0.1% in rinse-off products and 0.05% in leave-on products) Europe (up to a maximum of 0.1%) and Japan (up to a maximum of 0.1% in rinse-off products only).


Table 12 Antimicrobial activity of Iscaguard® Microorganism


Pseudomonas aeruginosa Staphylococcus aureus Candida albicans Aspergillus niger


CMI


Minimum inhibitory concentration(%)


0.03 0.02 0.03 0.06


Liquid blends developed to optimise the complementary properties of the individual actives


Although successful preservation can be achieved by using single-component preservatives, we at ISCA believe that it can often be achieved more effectively and more safely, through the use carefully designed preservative blends.


Why Blends?


An ideal preservative system must be: • Effective (i.e. have a broad spectrum of activity) • Safe to use • Safe at use levels • Stable in the product • Compatible with the product and packaging


It is rare to find a single preservative that meets all of the above requirements. Most preservatives have their plus points, but they usually also have some negatives associated with their use. However, if we stop thinking about “The Preservative”, and start thinking about “The Preservation System”, we can minimise the negatives and accentuate the positives.


One further consideration is that of time. Preserving a formulation using separate components can be time consuming. If the product fails the microbial challenge


Preservative Blends


test, the next stage of development can involve adding an extra component to combat the organisms that caused the initial failure. The revised preservative system may also fail the challenge test, resulting in still more preservative being added. This unfocussed strategy can result in too many preservatives at too high a concentration, and a significant delay for the product launch with all the associated cost implications.


The process may be simplified by testing a broad- spectrum preservative blend over a range of concentrations. This strategy, if correctly employed, can usually result in a challenge test pass at the first attempt, and at a concentration reasonably close to the optimum for that particular formulation. Closer optimisation can be achieved by testing two or more different blends.


For all these reasons, ISCA offers a range of preservative blends with all the advantages we can put in there. These products have been carefully developed to give a combination of preservatives in which the ratio of components is closest to the optimum activity for as many different formulations as possible.


An example of a preservation strategy


Better optimisation of the preservative system in a product may be achieved by testing many different preservatives, or preservative blends, over a broad range of concentrations. It is often difficult, however, to justify submission of more than 5 or 6 different options for challenge testing. On this basis, a general example of a possible preservation strategy is given below: Submit samples containing the following preservative blends:


Iscaguard® Iscaguard®


MPB @ 0.3, 0.6 and 1.0% PBA @ 0.3 and 0.6%


The results will indicate which of the blends is the more effective in the product under test. Iscaguard®


MPB is


included at 1.0% to try to ensure that at least one preservative treatment passes the challenge test, even if the lower concentrations fail. This strategy makes it more likely that the product can be launched without delay and, if the highest concentration is the only successful one, lower concentrations (in this example, 0.7, 0.8 and 0.9%) could be tested after launch to establish whether a reduction in the preservative concentration is possible.


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