Aseptic Processing
A manufacturing method where the product, container, and closure are sterilised separately and then assembled under extremely clean conditions. Most injectable peptide products use aseptic processing because peptides are too heat-sensitive for terminal sterilisation methods.
Technical Context
Aseptic processing for peptide products: drug substance and excipients are sterile-filtered (0.22μm membrane filter — peptides must be soluble and non-aggregating at filter concentration), containers and closures are separately sterilised (dry heat depyrogenation for glass at ≥250°C/≥30 min, gamma irradiation or autoclaving for rubber closures), and the sterile components are assembled in an ISO 5/Grade A cleanroom environment with ISO 7/Grade B background. Critical controls: environmental monitoring (viable and non-viable particle counts, settle plates, contact plates, personnel monitoring), aseptic technique (gowning, personnel qualification), and process simulation (media fill trials — filling containers with sterile growth medium instead of product, incubating, and checking for contamination — performed at least semi-annually, requiring <1 contaminated unit per 5000 filled). Aseptic processing has inherently higher contamination risk than terminal sterilisation, which is why media fill validation and environmental monitoring are essential.