Aseptic blending

Inoculum. Pleurotus sajor-caju was grown at 30°C on the above medium containing 1% glucose as a carbon source in 250 ml Erlynmeyer flasks on rotary shaker at 200 rpm for 60 h. The mycelial biomass thus produced was blended in a Waring blender for 1 min. under aseptic conditions in order to obtain an homogenous inoculum of well dispersed mycelial bits. The inoculum was used at the rate of 10% vol/vol. The inoculated experimental Erlynmeyer flasks were incubated at 30 C on a rotary shaker at 200 rpm for various intervals of time. 

A quantity of an appropriate sterilized placebo powder is blended with sterile excipients prior to filling (if needed) in a manner similar to the production process being simulated. The medium is passed through the run as though it were an actual product batch, and all routine procedures used in manufacture of a batch are performed. Once the medium has been processed, it is held for a period of time at least equal to that for aseptically produced materials. Any aseptic manipulations performed during and at the end of the hold period should be simulated hold times and product recalculation. 

Depending upon the formulations being produced, additional sterilized processing equipment may be present in this area for use in the process. This can include in-line homogenizers, static mixers, and colloid mills. Where sterile powders are produced, the aseptic compounding processes can include blending, milling, and subdivision equipment. 

While blending times and tablet press parameters may not be fully established for early phase clinical supply manufacturing of solid oral dosages, those variables have a much lower potential to directly affect product safety than sterility, endotoxin contamination, or objectionable types and levels of particulates do for sterile, parenteral clinical supplies. Because clinical supplies can be incompletely characterized, and are usually given to patients already in weakened conditions, those processes and their related validation data necessary to guarantee patient and product safety (e.g., sterilization and aseptic fill) are expected to be in place as early as Phase I clinical supply manufacture. ... 

For use in ice cream, frozen confectionery and certain types of beverages, citrus fruits may be passed through a colloid mill to form a homogenous paste. These finely ground products are made from the whole fruit and may be further blended with juice or natural peel oil emulsion in order to achieve a desired flavor profile and some degree of standardization. Such products are generally aseptically processed and packaged. The process inactivates any enzyme systems and results in a shelf-stable product. 

It is my belief that the availability of on-line computer control has enabled the food process plant designer to achieve this end. Countless plants dealing with the blending of wine or fruit juices, the fermentation and maturation of beer, the continuous production of ice cream and the aseptic processing of a wide range of food products, now rely upon process logic as written in computer programs. 

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