Quality

/Quality
Quality2019-03-27T14:02:41+00:00

Certification

The company works under quality control system according to the norm ISO 9001:2015.
The quality system is certified by the agency TUV Italia, and includes all design, construction and commissioning activities, also referring to outsourcing prefabrication activities.

Top Quality

Polaris handles and carries out directly all verification and test activities for the systems, from design phases to commissioning. The control activities are planned since the early phase of the project, in collaboration between project engineering and quality control functions. For each project it is carried out, besides the normal control activities, a general process verification of safety and construction aspects, which is made before the construction activities. Where foreseen, it is carried out a general safety and functional verification with HAZOP methodology, together with the client and/or other parties involved in the project.
The plant is completely pre-assembled in workshop, and submitted to rigorous leak tests. Where possible (for units with lower sizes) the complete functional tests are carried out. The control systems are completely checked with simulation of process signals (hardware and software).
In commissioning phase the final verifications are carried out before the plant start-up, including the qualifiaction of mechanical installation and connections, the check of calibration and functionality of the loops, the verification of utilities and compatibility with external circuits. In such way it is further verified, from functional and safety point of view, the integration of the plant in the customer existing systems.

For applications in pharmaceutical industry, Polaris prepares and carries out the verifications foreseen for FDA validation of the system. In particular, during design phase the Functional and Design Specifications are prepared on the basis of the client URS, which, together with other design documents, are the basis for the successive qualification activities.
All the design, in particular for system that have direct impact on the customer production, like solvent recovery units for internal use, is made taking into account the matters related to the final validation phase to which the system shall be submitted after installation. In particular way the managing system and the section of the plant related to the product control before reuse are adequately configured.
At the end of the prefabrication activities, the qualification protocols are prepared (IQ, PQ). Such documents shall be checked and approved by the client QA. Before the plant start-up all the verifications foreseen by the protocols are carried out, both for installation aspects as well as the functionality and the calibration of the elements included in the system are concerned.
In this way several units supplied by Polaris have successfully passed the validation by FDA. For a constant update about GMP and FDA norms, Polaris is associated to ISPE (International Society for Pharmaceutical Engineering).