DOCUMENTATION M.F. Packaging

MF Packaging submits each machine to a rigorous commissioning with in-depth checks on all the units of the packaging machine:
* Electrical panel
* Software
* Mechanical components
Batching tolerances and the sealing, even under the worst conditions are checked by using specific instruments.
Moreover, we carry out an operational commissioning on the machine through analysis and validation protocols designed according to GAMP guidelines.
All the Packaging Machines come with:

• a dedicated user and maintenance manual indicating the settings for the packaging machines
• list of commercial components
• list of spare parts with exploded views
• wiring and pneumatic diagrams
• manual with list of alarms
• diagram with overall clearances, blueprint process and bag diagram
• certificates of materials used
• commissioning certificates
• EC certificates

Packaging Machines intended for the pharmaceutical sector come with IQ and OQ validation protocols drawn up in accordance with EEC directives 91/356/EEC, 91/341/EEC and FDA21CFR parts 210 and 211