Sterile drug aseptic processing

Sterilization of the finished drug delivery formulation is an important consideration often overlooked in the early design of lactide/glycolide delivery systems. Aseptic processing and terminal sterilization are the two major routes of affording an acceptably sterile product. Both of these methods are suitable for products based on lactide/glycolide polymers if proper care is exercised in processing or selection of the treatment procedures. 

FDA Guidelines on Sterile Drug Products Produced by Aseptic Processing. June, 1987. 

U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (2004, Sept.), Guidance for industry Sterile drug products produced by aseptic processing—Current good manufacturing practice, DHHS, Rockville, MD. 

It should be noted that aseptic assembly of a sterile product becomes difficult with large volume containers and the Food and Drug Administration, for example, would be unlikely to approve an aseptic process for container volumes in excess of 100 mL, i.e., by definition only small volume injectables are acceptable for aseptic assembly. 

Addition to an aseptic processing line of new equipment made of different materials (e.g., stainless steel versus glass, changes between plastics) that will come in contact with sterilized bulk solution or sterile drug components, or deletion of equipment from an aseptic processing line. 

This section will concentrate on that portion of the aseptic process wherein the drug product is sterilized by filtration. From the earlier discussion, sterile filtration is perhaps a misnomer, since the sterile filtrate is almost always processed further under aseptic conditions, which involves a risk of contamination [44], Therefore, to speak of drug product sterilization by filtration as being as final a processing step as the steam sterilization of a product could possibly lead to erroneous assurances or assumptions. Since a sterile filtrate can be produced by filtration, however, we will continue to refer to the process as product sterilization by filtration. 

U.S. Food and Drug Administration, proposed revised Guidelines on Sterile Drug Products Produced by Aseptic Processing. Rockville, MD FDA (Nov. 30, 1998). 

FDA. FDA s proposed current good manufacturing practices (GMP) for regs. for large volume parenterals (LVP). Fed Reg (June 1, 1976). Preliminary Concept Paper of Sterile Drug Products Produced by Aseptic Processing, draft paper, Sept. 27, 2002. 

U.S. Food and Drug Administration (FDA) (2004), Guideline on sterile drug products produced by aseptic processing, FDA, Washington, DC. 

Food and Drug Administration (FDA) (1991), Use of aseptic processing and terminal sterilization in the preparation of sterile pharmaceuticals, FR 56, 354-358. 

The lyophilized drug nanosuspensions can be transferred to a hnal dry oral dosage form such as tablets or reconstituted prior to administration. Drug nanosuspensions can be directly used as parenteral products. A shelf life of up to three years was shown for selected nanosuspensions. Sterilization can be achieved by aseptic processing of previously sterilized components, membrane filtration for particles sufficiently small or for drugs that can withstand it, steam sterilization, or y-irradiation. 

The bulk production of sterile drug products such as antibiotics, corticosteroids, insulin, and certain biotechnology products requires that a number of processes be carried out under aseptic conditions. These processes can be evaluated in a manner adapted from those employed for aseptic filling processes. A joint PDA/PhRMA task force has developed the definitive guidance document on this subject. ... 

The FDA Guidelines for Sterile Drug Products Produced by Aseptic Processing describes the critical points that must be considered when filling the final product. " Biotechnological products cannot be... 

Compliance program guidance manual, 7356.002A. In Sterile Drug Process Inspections FDA, CDER, October 1990. Guideline on Sterile Drug Products Produced by Aseptic Processing FDA, CDER, June 1991. 

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