IRISYS’ cGMP (current Good Manufacturing Practices) contract manufacturing services include Aseptic Contract Manufacturing. This involves aseptic processing, which encompasses aseptic filling and aseptic packaging.
The aseptic manufacturing of sterile drug products that are subject to a new or abbreviated drug application (NDA or ANDA) takes specific know-how and proficiency. IRISYS is well-versed with the FDA’s “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice.”
During aseptic processing, the drug product, container, and closure are first subjected to sterilization methods separately, and then brought together. Before aseptic assembly into a final product, the individual parts of the final product are generally subjected to various sterilization processes. To ensure product sterility from initial processing through aseptic packaging, the sterilization, aseptic filling, and closing operations are all validated.
IRISYS has the experience and expertise to safeguard the aseptic processing of your drug product.
IRISYS provides the following Aseptic Contract Manufacturing services:
- Aseptic processing
- Aseptic filling
- Aseptic packaging