Natech Achieves ISO 15378 Certification, Elevating Pharmaceutical Packaging Capabilities
Ronkonkoma, NY — June 24, 2025 — Natech Plastics, a member of STRATEC, is proud to announce that it has earned ISO 15378 certification, a globally recognized standard specifically designed for primary packaging materials used with medicinal products. This achievement reinforces Natech’s commitment to quality, traceability, and risk management in pharmaceutical manufacturing.
“As we continue expanding into high-risk pharmaceutical and syringe applications, ISO 15378 gives our clients added confidence in our systems, processes, and people,” said Joseph Valenti, Quality Manager at Natech. “This certification isn’t just a milestone—it’s a reflection of how seriously we take our role in protecting patients and supporting our partners.”
Developed with Good Manufacturing Practices (GMP), ISO 15378 includes strict requirements for quality management systems, product traceability, risk mitigation, and regulatory compliance. By achieving this certification, Natech demonstrates its readiness to support pharmaceutical clients through every stage of the product lifecycle, from design and automation to cleanroom manufacturing and scale-up.
“Even the smallest defect in pharmaceutical packaging, such as a flash on a syringe, can have serious consequences,” Valenti added. “That’s why we pursued ISO 15378. Our clients need a partner who understands that quality isn’t optional, it’s life-critical.”
Across the pharmaceutical industry, there is increasing demand for sterile, safe, and compliant packaging solutions. Natech’s existing strengths in precision injection molding, cleanroom production and assembly, and advanced quality systems make it a reliable partner for pharmaceutical companies seeking supply chain assurance and manufacturing excellence.
With this new certification, Natech is well-equipped to serve a broader range of pharmaceutical clients, offering not only validated processes before and during production, but also a deep understanding of regulatory expectations and risk-based design.
About Natech Plastics
Natech Plastics, a STRATEC Company, specializes in the contract manufacturing of custom products for the medical, diagnostics, and pharmaceutical industries. With integrated services that span from concept through commercialization, Natech supports regulated companies with engineering, precision tooling, injection molding, assembly, and automation.