Excerpted from BioPharm International's editorial titled, "Prepping Fill/Finish Systems to Ensure Quality Output."
A holistic approach to validation and quality assurance is essential.
Biologic drugs are highly valuable in treating diseases, and assurance of sterility and proper final product quality is essential. Appropriate testing must be conducted to ensure the filled vials, syringes, cartridges, etc. contain the correct quantity of sterile, contaminant-free product. Aseptic process simulations are crucial for the assessment of aseptic filling capabilities.
The best approach, agrees Maria Lacourt, director of manufacturing operations for Alcami, is to conduct a holistic assessment of all the controls for the process and work toward a facility design that ensures proper execution of the process. “Beyond meeting requirements for the relevant room classification, the right equipment must be identified that enables optimum performance within appropriate containment systems such as isolators, which ensure reduced intervention of operators during aseptic processing.”
In addition to proper training and qualification of staff executing the filling process, Lacourt also stresses the importance of managing the materials used in the process. “It is important to identify vendors, establish container closure integrity, and assess all of the properties of the materials that can impact product quality attributes,” she explains.
Media fill studies
Aseptic process simulations (APS), also referred to as media fill studies, are critical to qualification of an aseptic facility. They demonstrate the ability of the filling process to operate consistently all of the time due to the design of the process, facility, equipment, and the training of the personnel. “The goal is to determine the microbiological risk associated with the performance of specific interventions and to challenge the way those interventions are executed in a simulation to confirm that they do not in any case affect the sterility of any manufactured product,” she says. Media fill execution is also used to certify the personnel who will participate in the sterile manufacturing process.