Our system has been filed with both the State of California Food and Drug Branch and FDA as a low acid aseptic system.   We have conducted the appropriate microbiological challenge testing on the system and submitted reports and filings to both agencies.  

Our process system is capable of utilizing indirect heating (tube-in-tube heat exchange). Our system has an aseptic homogenizer capable of operating up to 5000 psi.  We can homogenize product at any point in the process.   We can run low and high acid aseptic products and produce samples that require no refrigeration by filling with our aseptic bag filler (Intasept bag filler).  We also can run hot-fill-hold trials for high acid products.   At our facility we normally run 5 gallon batches, however, we can run more or less product depending on how many samples you would like.  Keep in mind that there is about a 30% loss on the small batches from interface dilutions and loss between product filling.  Our process system can be coupled with an Intasept Aseptic Bag Filler.  We have 2L bags with an EVOH inner layer and a foil layer.  The bags could give you a fairly accurate representation of shelf life.  We can fill any volume in the bags up to 2 liters.  We can also fill bottles in addition to bags.  Bottles are what we normally fill.  When we fill bottles, they must be treated as ESL and kept under refrigerated conditions.  This is because the bottles are filled by hand under atmospheric conditions and thus are non-sterile.  We have a number of process filings that we use for different products, which will likely cover your product.  However, in some cases depending on the product, we do need to submit new process filings to the State of California and FDA.  The State of California normally takes about two or more weeks to issue a process letter.  Since we are under the State of California Food and Drug Branch Cannery Inspection act, we must have all production records reviewed after an aseptic process trial.  This normally takes a couple of days after the trial.   In addition, should a process deviation occur (i.e.. A flow spike or temperature dip below the scheduled process) before the product is released we would have to submit a request to the State Lab to clear the deviation.  This usually is not a problem, but can take a couple of weeks or more.   Finally, we have a standard 7 day hold on aseptic product before we release.  We incubate the product during this time and then examine after 7 days to confirm sterility.  You can take any bottles filled immediately after the trial. 

The normal charge for a plant trial is $XXXX per day.  As such, it is most economical to run a number of different product variations in a day.  Typically we can run 5-6+ trials in a day depending on size of the batches  (4-5 gal batches normally).

Our aseptic pilot system is located in a large lab area with adequate bench top and workspace needed for preparing product batches.  We have a high speed mixer capable of mixing batches up to approximately 10 gallons.  We have a high shear mixes (Silverson and Boston Shear) as well as heat jacketed kettles and tanks in the full scale pilot plant which are available at an extra charge.  Our staff will provide as much assistance as is requested for preparing product batches.