The Expanded Application of Aseptic Processing

The Expanded Application of Aseptic Processing

Aseptic processing is a means of handling components, materials, and equipment in such a manner that foreign microbials and endotoxins (a pyrogenic product of microbial physiology) that exceed pre-determined acceptable levels are not introduced to the product stream.

On one hand, aseptic processing may assure a level of sterility of handled sterile components, materials, and equipment. On the other hand, it may assure an acceptable level of exposure to foreign microbials and endotoxins in handled non-sterile components, materials, and equipment. Aseptic processing does not mean sterile in all circumstances; it is a controlled state of microbial exposure to the product being produced at any step of that product’s overall manufacture.

In order for a manufacturer of a sterile drug product to incorporate aseptic processing into the overall manufacturing of the product, aseptic processing can be applied for the most part at the final finish fill steps. The necessity for incorporating aseptic processing at the levels of operational and facility control during the manufacturing of the bulk active chemical ingredient, is not typically necessary for the reason discussed earlier: the typical harshness of a chemical process. Therefore, the added manufacturing cost of such sterile drug products is minimized by limiting the application of aseptic processing to the final steps of the overall manufacturing operation. This form of aseptic processing would assure a level of sterility of handled sterile components, materials, and equipment during manufacture.

A producer of a sterile biotechnology-derived pharmaceutical products must not only incorporate aseptic processing during the final finish fill steps as the drug manufacturing counterparts do, but must also provide added levels of operational and facility control to the manufacturing of the bulk biological active ingredient. This produces an acceptable level of product stream exposure to foreign microbials and endotoxins in handled non-sterile components, materials, and equipment during manufacture, but can result in a tremendous additional manufacturing cost to the final sterile product form.

The Expanded Application of Aseptic Processing