Templates034 Expands Cleanroom Capacity with New ISO Class 7 Facility
Templates034 is proud to announce the completion and commissioning of our new 2,500m² ISO 14644-1 Class 7 (10,000) cleanroom injection molding facility, tripling our medical and pharmaceutical manufacturing capacity to meet surging global demand for precision-molded healthcare components.Facility Highlights12 all-electric injection molding machines (50-450 tonne) with servo-driven precisionDedicated material handling with central drying, conveying, and nitrogen blanketing systemsHEPA-filtered laminar airflow maintaining Integrated automated optical inspection (AOI) and CMM verification stationsQuality InfrastructureISO 13485:2016 certified quality management system for medical devices21 CFR Part 820 compliant design and production controlsFull IQ/OQ/PQ validation capability with statistical process control (SPC)Environmental monitoring: continuous particle counting, temperature (21±2°C), and humidity (45±10% RH)The new facility is fully operational and accepting new project inquiries for medical device, diagnostic, pharmaceutical primary packaging, and drug delivery system applications.
Templates034 Achieves IATF 16949 Recertification with Zero Non-Conformances
Templates034 is delighted to announce the successful recertification of our IATF 16949:2016 quality management system with zero major and zero minor non-conformances — an achievement reflecting our unwavering commitment to automotive-grade quality across all rubber and plastic manufacturing operations.Audit ScopeFull scope covering rubber compression/transfer molding, plastic injection molding, and extrusion operations128 process audit points examined across 6 manufacturing cellsCustomer-specific requirements (CSR) verification for 8 major automotive OEMsSupply chain management audit including approved supplier list and incoming inspectionQuality Performance MetricsCustomer PPM: 2.3 (target On-time delivery: 99.7% (target 98%)Internal scrap rate: 0.8% (target COPQ (Cost of Poor Quality): 0.3% of sales (target Continuous ImprovementThe auditor specifically commended our Layered Process Audit (LPA) program, our Poka-Yoke implementation reducing human error by 60%, and our real-time SPC dashboard providing instant visibility across all critical-to-quality (CTQ) characteristics.
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