To protect the medical product and its packaging from contamination, sterile injectables must be manufactured in a highly precise and carefully controlled way. This means using sterile raw materials, maintaining sterile environments, and following strict procedures to prevent contamination at every step of the manufacturing process.
There are two primary methods for manufacturing sterile injectables: terminal sterilization and aseptic fill-finish.
This approach relies on carefully controlled environments and procedures to reduce the risk of contamination during the manufacturing process, but actual sterilization occurs as a final step before the product is released. Typically, the product and container are sterilized by steam and/or gamma radiation.
The process is relatively faster than other options and more cost-efficient, as it requires less specialized knowledge, equipment and processes – but it can only be used with products and materials that can withstand temperatures up to 121 degrees Celsius or radiation exposure.
This highly specialized process is used to produce the many sterile injectable products that cannot tolerate terminal sterilization. This means that full sterility must be maintained across all materials and packaging, process steps, and outputs throughout the entire manufacturing process.
That is critical because there is no final step to sterilize the drugs in their containers before shipping. Aseptic fill-finish requires advanced equipment and a deep understanding of the complex processes, testing methods, and regulatory standards this method requires.
To produce sterile injectables, there are five key components that must be carefully controlled from start to finish:
- Sterile raw materials: All components used to formulate the drug product must undergo rigorous testing to confirm their purity and potency.
- Sterile compounding: The process for generating the active pharmaceutical ingredient (API) must be carefully defined and completely sterile.
- Sterile containers and closures: The product itself must be placed in contaminant-free injection systems with sterile closures.
- Sterile filling: The product must be placed in its container in a cleanroom environment that excludes all potential contaminants, using a detailed process that also helps avoid contamination.
- Sterile packaging: If a product will be placed in some form of packaging (e.g., carton, blister, delivery device, etc.), this step of the manufacturing process must also be designed to prevent the filled container or its contents from being compromised.
Because the aseptic fill-finish process is so technically complex, companies that develop sterile injectable therapies often turn to specialized manufacturing partners like Vetter for support. Aseptic fill-finish companies typically have dedicated facilities and a specialized workforce like ours.
Manufacturers that handle sterile injectables may also offer specialized support for specific phases in a product’s development as well.
That can include both sterile injectables for clinical and commercial filling services for products that are already on the market. These projects often involve very different processes, production volumes, and timelines that an expert manufacturer can help their customer navigate and plan for.