ASEPTIC FILL AND FINISH

SPS offers the solution for companies that are in need of CMO capacity with regard to filling of syringes, cartridges and vials, as well as assembly and packaging of pre-filled syringes and auto-injectors.
In case you require short term access to additional capacity or a complete technology transfer:
we are there to enhance your product by adding value through the manufacturing process.

SPS capabilities:

– Aseptic filling of cartridges, syringes and vials, available in nests/tubs.
– Assembly of pre-filled syringes and auto-injectors.
– Possibility to handle high-potent APIs.

Aseptic filling:

– State-of-the-art automatic aseptic filling machine.
Optional: filling with nitrogen flushing during stoppering.
– Capacity: max. 8,000 syringes/hour.
– The filling process is performed in an isolator.
The solution is taken from a disposable bag, via single-use tubing.

Testing:

  • Automatic particle measuring system.
  • System for air sampling.
  • Automatic fill weight control (% is flexible).
  • Stopper presence/position checked manually.
  • Visual inspection (semi-automatic machine).
  • Full analytical testing.

Assembly of autoinjector devices for SC injection*

– Filling of 1 ml syringes, volumes of 0.3 – 1 ml.
– Automated assembly into autoinjector devices.
Two lines available, capacity 40 devices per minute.
– Secondary packing into multiple SKUs.
– Serialization.

* Other devices will require additional equipment.