Documentation
MF Packaging machines
MF PACKAGING subjects each machine to a rigorous testing process with through inspections of all packaging machine components:
Through the use of specific instruments, dosage tolerances and seal integrity are verified even under the worst conditions. Additionally, we perform functional testing of the machine using analysis and validation protocols developed according to GAMP guidelines.
All packaging machines are equipped with:
- dedicated user and maintenance manual, with packaging machine settings instructions
- list of commercial components
- spare parts list with exploded views
- electrical and pneumatic diagrams
- alarm list manual
- dimensional layout, blueprint, and pouch diagram
- material certificates
- test certificates
- CE certifications
PHARMACEUTICAL SECTOR
The packaging machines for the pharmaceutical sector are equipped with validation protocols (FAT, SAT, IQ, OQ and PQ), FDA certification and CFR21 part.11 software validation.