Quality
Analysis and improvement
TECNinox Group acts by adopting Quality Management System model according to ISO 9001:2015. The daily activities, internal policies, processes and procedures are recorded and analyzed to enable the Group to offer customers quality products and services. The approach is based on the PDCA Cycle – Plan, Do, Check, Act – with a view to Continuous Improvement, of processes, tangible and intangible resources and, consequently, of the final product.
Certifications
Being a supplier for Pharma and Biotech customers means respecting the highest standards of production, for their and consumer’s safety. For this reason, TECNinox Group designs plants and machinery according to the highest technological standards and compliant with the latest GEP, ASME, cGMP, GAMP and FDA regulations. Each project is customized, thus ad hoc certifications are provided according to customer specifications, such as: PED Module G Directive, Machinery Directive, Atex Directive, Electromagnetic Compatibility Directive and Low Voltage Directive.
TECNinox S.r.l. is certified ISO 9001:2015.
Discover and download the certifications
Documentation
For each plant and machinery, a complete documentation is delivered, that is compliant with GMP and customers’ requirements. The Documentation team works, from the first phases of the project, to collect documents and data: every single detail of the plant is scrupulously recorded to ascertain its conformity: P&ID, component list and certificates of the materials used, welding book and commissioning test list. At the same time, the Functional and Design Specifications of the plant are developed, filling out the test protocols tailored on each plant and used during FAT/SAT/IOQ/PQ. IQ (Installation Qualification) tests verify compliance of the system with the URS (construction and placement of equipment, slopes, welding, valves, passivation). OQ (Operational Qualification) tests verify that the system operates within the operating ranges as defined during the manufacturing. Finally, with the PQ (Performance Qualification) tests, the last step of Validation, it is ascertained all equipment is working within the accepted range as specified, under real conditions.
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Every project consists of a series of precise processes
handled by specific departments.