Considerations for Aseptic Processing and Sterile Fill-Finish

 

Considerations for Aseptic Processing and Sterile Fill-Finish

Sterile injectables such as liquids filled in vials are the first drug products that come to mind when the term “sterile fill-finish” is mentioned. While suspensions, emulsions, and liquid solutions are very common candidates for sterile fill-finish operations, lyophilization and powder fills are equally performed under aseptic conditions. 

At AbbVie, the nature of your biologic drug notwithstanding, you can count on us when it comes to aseptic fill-finish manufacturing. We will provide reliable, safe, and ready to use products. 

Every individual component of a drug product must pass through the sterilization process before aseptic processing. This includes water for injection (WFI), active pharmaceutical ingredients (APIs), and any other excipients involved in a formulation. Some FDA-recommended methods to sterilize components include the following: 

●Radiation Sterilization
This is a method where a component is opened to electromagnetic radiation to destroy microorganisms. 

●Heat Sterilization
In this sterilization method, a component is exposed to moist heat or dry heat. This is the most used sterilization method. 

●Filter Sterilization
In this method, a component is dissolved in water for injection or other appropriate vehicles. After that, it is passed through a membrane with a small pore size like a 0.2 micron. 

●Ethylene Oxide Gas Sterilization
This method is primarily used to sterilize bulk container systems and active pharmaceutical ingredients powder where a component is opened to ethylene oxide over a long time.  

Cleanroom Facilities 

Aseptic processing and medicine fill-finish operations occur in cleanrooms designed to accommodate the flow of materials, equipment, and personnel during the process of manufacturing.

EM (Environment monitoring) activities are essential for cleanroom operations. Right EM demands proper methods to frequently take, evaluate, and interpret data on the cleanrooms’ surface and air. 

In addition to the monitoring of particles, the detection of microorganisms is attained by these methods:

●Active Air Monitoring
This process uses devices that often sample the air for particles, including membrane, centrifugal, and impaction samplers.

●Passive Air Monitoring
This process uses the collection of devices like settling plates analyzed by a controlled lab for microorganisms.

●Surface Monitoring
This process involves the sampling of walls, equipment, floors, and contact surfaces regularly. 

Container System

Aseptic fill-finish processing and sterile fill-finish operations can be used in tons of container systems that are made of either plastic or glass, which includes cartridges, vials, ampoules, bottles, and syringes. Single-dose BFS (Blow Fill Seal) containers molded from new multidose and plastic may also be used for ophthalmic preparations. 

Personnel 

Personnel who enter a fill finish manufacturing area must be coached in cleanroom behavior and procedures. Sterile fill-finish operations and aseptic processing are put in place to decrease human interventions. While personnel’s actions in the cleanroom go a long way to ensure the sterility of products. 

Personnel is a primary source of contamination. This is why a proper training program is recommended because it should cover a minimum of the following:

●Hygiene

●Gowning

●Aseptic technique

●Microbiology

Ongoing evaluation and training of cleanroom procedures and personnel are essential for ensuring that drug products are not exposed to contamination risks. 

Lastly, the environmental monitoring crew plays a massive role in noticing adverse trends and anomalies in the manufacturing of aseptic.

To learn more about Abbvie and how we can assist you with aseptic fill-finish, feel free to contact us and reach out to us; we shall be more than pleased to support you.