Services · Step 2
Installed, tested and ready for qualification.
We take the machine from our factory in Bologna to your line, with the tests and documents your validation team needs.
The process
Four stages, agreed in advance.
The plan and acceptance criteria are agreed with your team before the machine leaves Bologna.
- 01
Factory acceptance test
The machine is tested in Bologna against the agreed criteria. Your team can attend in person or remotely.
- 02
Delivery and installation
Our engineers install the machine and connect it to your line and utilities. Only electrical supply is needed.
- 03
Site acceptance test
The machine is tested again at your plant, with your bags and in your production conditions.
- 04
Qualification support
Documentation and support for your IQ, OQ and PQ, ready for your quality system.
Documentation
Built for your validation file.
The machines are designed around EU GMP Annex 1, USP <1207> and EU GMP Annex 11. We provide the documents that support your qualification.
- IQ and OQ protocols: scope to be confirmed
- Support for your PQ with your own bags
- Data integrity documentation for Annex 11: specifics to be confirmed
- Operator and maintenance manuals
Handover
Your team, ready from day one.
Operator training
Hands-on training at handover, so operators can run tests and handle rejects.
Maintenance training
Routine checks and maintenance tasks for your engineering team.
Languages
Training in English and Italian. Other languages to be confirmed.
Send us your bags. We will show you the result.
A feasibility study on your own bag formats, with a written report your QA team can use.