SteriPack’s competences comprise of drug device assembly. The components are obtained in the process of supply management or in-house manufacturing using cleanroom injection moulding or additive manufacturing processes. Drug delivery device assembly is compliant with ISO and cGMP regulations and takes place in dedicated Grade D cleanrooms.
Starting off small to a big full-scale production run, SteriPack Group shares their expertise and ideas for the optimisation of the assembly process while finding the most competitive solution. Depending on the Customer’s requirements and the product lifecycle, the solutions vary from manual to semi-automatic or automated assembly processes.
All assembly processes are ISO 13485 and FDA requirements compatible. We follow good manufacturing practice for medical devices.
Some of the key features in our assembly and packaging process include:
- Cleanroom assembly in both Class (7) 10,000 and Class (8) 100,000 environments
- Manufacturing pilot lines to debug, analyse, validate compliance and finalise for production
- Process Failure Mode and Effect Analysis (FMEA)
- Epoxy UV curing assembly, mechanical assembly, part pouching and sealing, and tray sealing from sub assembly to delivered, finished, sterile devices
- Verification and validation testing; tensile, compression, and torque testing; leak testing by pressure decay and flow rate
- Heat staking and ultrasonic welding