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Simple.
Reliable.
Resilient.
Compared to more traditional sterile liquid fill-finish formats, the ApiJect Platform has designed simplicity and reliability into its material procurement and production supply chain.
Simplified Material Procurement
Blow-Fill-Seal (BFS) and prefilled injection systems designed on the ApiJect Platform require only two primary materials to be procured: pharmaceutical-grade resins (LDPE and PP) and cannula.
- Both materials can typically be sourced in all major markets and reliably produced in sufficient scale.
- Needles and resin potentially can be stockpiled at the manufacturing facilities, ensuring localized supply.
- Made of low-density polyethylene, BFS containers have very limited delamination issues.
- Materials used in the secondary packaging process, such as a drug label, foil pouch, and boxing, are generally also available in all major markets.
Highly Compact End-to-End Supply Chain
- Once a mold is installed and the line is qualified, a BFS machine can scale-up reliably and quickly.
- Needle hub manufacturing for Prefilled ApiJect Injectors* is done by Tae-Change Industrial™ of South Korea, the world’s second largest cannula supplier by volume.
- A BFS filling line only requires approx. 500 sq. ft. of ISO-7 space.
- ApiJect pre-set modular manufacturing units fulfills response for local, regional and international sterile manufacturing needs.
- BFS containers are resistant to breakage or shattering, making them a very robust option for distribution and warehousing in all markets.
- Kitting of the BFS containers and attachable components can be done in the same facility as the BFS manufacturing (today it is done in a separate facility).
*The Prefilled ApiJect Injector and its components are not cleared by the FDA or other regulatory bodies.
