Documentation and testing
Documentation and testing of packaging
Each and every OMAG machine is subjected to a rigorous set of tests, with and without the presence of the customer. During this phase, scrupulous controls are conducted on all packaging systems on the machine:
* Electrical panel
* Mechanical components
We simulate the production processes the machine will have to perform once installed at the customer’s facilities, verifying all technical specifications agreed to with the buyer.
Production tests are conducted at the maximum speed agreed to, using the customer’s product and packaging; specific measuring instruments are employed to check filling tolerances and seals, even in the most unfavourable conditions.
In addition, we perform a functional test on the machine, through analysis and validation protocols conforming to GAMP guidelines.
Finally, the machine is tested at the customer’s location, with OMAG’s best technicians, providing advice and training the customer’s production personnel.
All machines are shipped with the following documents:
- dedicated instruction and maintenance manual, with indications on packaging settings;
- list of commercially available components;
- list of spare parts with exploded diagrams;
- electrical and pneumatic diagrams;
- alarm messages manual;
- clearance diagram, blueprint and package diagram;
- certificates of materials used;
- EEC certifications;
- test certificates.
Machines designed for the pharmaceutical sector are provided with IQ and OQ validation protocols, drawn up in accordance with Directives EEC 91/356/EEC, 91/341/EEC and FDA21CFR parts 210 and 211.