Process validation and qualification
During the validation phase, every mold, whether customer-supplied or manufactured by us, undergoes comprehensive testing in real production conditions. Our standard validation process is conducted in accordance with ISO 13485, including: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
Validation to PPAP (Production Part Approval Process) and other customer-specific standards is carried out as required as well. Depending on project requirements, we also perform: DoE (Design of Experiments), Pro-Op (systematic, step-by-step process optimization), Filling and flow studies.
Mold inserts for micro components, such as those used in microfluidic applications, are inspected and validated using high-precision confocal microscopes able to detect even the smallest deviations in surface topography.
Further analytical capabilities include: CT scans, Polariscope analyses.
RKT’s structured and comprehensive validation approach ensures maximum process stability, regulatory compliance, and long-term production reliability.