Certification

The company works under a quality control system, according to the ISO 9001:2015 standard.

The quality system is certified by the agency TUV Italia, and covers all design, construction, and commissioning activities, including outsourcing prefabrication activities.

Testing procedures

Polaris handles and directly carries out all verification and test activities for the systems, from design phases to commissioning.

The control activities are planned from the early phase of the project, in collaboration with project engineering and quality control functions. Beyond standard control activities, a general process verification of safety and construction is carried out before construction activities begin.

When necessary, a general safety and functional verification with HAZOP methodology is also performed, together with the client or other parties involved in the project.

The plant is completely pre-assembled in the Polaris workshop, and subjected to rigorous leak tests. Where possible for smaller units, complete FAT can be carried out before shipment. The control systems are completely checked with a simulation of process signals (covering both hardware and software).

FDA validation

For applications in the pharmaceutical industry, Polaris prepares and carries out the verifications needed for FDA validation of the system.

During the design phase, the functional and design specifications are prepared based on the client URS, which, together with other design documents, are the basis for the successive qualification activities.

All designs take into account the final validation phase to which the system is submitted after installation, particularly for systems that have direct impact on the customer’s production (like solvent recovery units for internal use). Specifically, the managing system and the section of the plant designated for product control are adequately configured before reuse.

After the prefabrication activities, the qualification protocols are prepared (IQ, PQ), and are checked and approved by the client QA.

Before the plant start-up, all necessary verifications are carried out for installation, as well as for the functionality and the calibration of the elements included in the system.

To stay up-to-date on GMP and FDA standards, Polaris is associated with the ISPE (International Society for Pharmaceutical Engineering).

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