White Paper Regarding
Aseptic Filling In The Laboratory
Aseptically filled foods* that are intended for un-refrigerated distribution and sale in the US are regarded as canned foods and regulated by the Food and Drug Administration. This is because of potentially lethal risks associated with errors or improper methods.
For products with pH>4.6, these regulations require that all processes and records involved in sterilizing the product, the package and the machinery are properly challenged to demonstrate and document their effectiveness before permission is granted to manufacture product for sale. This is a formal and very detailed process that requires a qualified process authority to review and organize the relevant information before the process is filed with the FDA.
For products with pH<4.6, the regulations are not as rigorous only because these products do not pose a lethal risk. They do, however, present the risk of spoiling and causing illness or damage from fermentation and burst packages.
By the letter of the law, research products that are filled in the laboratory and unrefrigerated may not be subject to the same canned food regulations because they are not intended for sale. Thus, R&D personnel may be tempted to try aseptic filling in the laboratory. Similarly, equipment manufacturers may consider building equipment to “aseptically” fill products for research using sterile or aseptic techniques, or they may promote equipment to do so. This issue can be further confused by legal definitions and requirements that vary from country to country.
In all of this, it is critical to keep a clear eye on the facts. Attempting to aseptically fill low-acid non-refrigerated products for human consumption without following the all the methods required by the FDA is dangerous. It presents a foreseeable risk that may be lethal. Without the proper challenge studies, the effectiveness of processing and packaging operations has not been documented. It has not been formally established to the satisfaction of experienced regulatory officials and experts.
MicroThermics provides laboratory equipment and services for aseptic processing and ultra-clean filling of research samples. These samples require refrigeration to eliminate the risks described above for a reasonable shelf-life. We do not provide equipment for aseptic processing and aseptic packaging of low-acid products without refrigeration to companies that do not satisfy the legal requirements consistent with their manufacture. We feel this risk is too high in spite of the potential advantages.
MicroThermics recommends that anyone seeking to purchase aseptic filling equipment for the laboratory consult a qualified process authority to learn how to properly challenge, qualify and implement an aseptic filling line.
*with water activity exceeding 0.85 and packaged in hermetically sealed containers.
