Aseptic Process Operation in pharmaceuticals

Aseptic Process Operation

1. Aseptic Processing Operation Presented by

2. Aseptic Processing Aseptic processing is defined as “handling of sterile product, containers, and/or devices in a controlled environment, in which the air supply, materials, equipment, and personnel are regulated to maintain sterility” ( ISO 13408-1, 2008)

3. Producing Drug Products By Terminal sterilization Product containers are filled and sealed under high-quality environmental conditions designed to minimize contamination, but not to guarantee sterility. Product in its final container is subject to a sterilization process such as heat or irradiation. Aseptic processing Drug product, container, and closure are subject to sterilization separately , and then brought together. Because there is no process to sterilize the product in its final container, it is critical that containers be filled and sealed in an extremely high –quality environment .

4. Terminal Sterilization Sterile Drug Product !

5. Aseptic Processing Drug Product Sterilization Process Container Closure Excipient Sterilization Process Sterilization Process Sterilization Process Sterile Closure Sterile Excipient Aseptic Processing Sterile Drug Product Sterile Container Sterile Final Product Can use multiple sterilization processes each optimized for the individual component

6. Bacteria, virus, fungi and other viable microbes Bacterial spores and endotoxins Non viable Particles like dust, fibers, glass and other visible and sub-visible particulates suspended in the air and may contaminate product. Contaminating Agents

7. Extremely heat stable – recommended conditions for inactivation are 180 C for 3 hours. Endotoxin: a pyrogenic (fever inducing) substance (e.g. lipopolysaccharide) present in the bacterial cell wall. Endotoxin reactions range from fever to death. Endotoxin Testing LAL Assay (Limulus amoebocyte lysate) ENDOTOXIN LIMIT FOR WFI IS 0.25 EU/ml Quality Control

8. References EU GMP Annex 1: Manufacture of Sterile Medicinal Products – Draft revision 2020

9. Thanks