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 Highlights

• 12 all-electric injection molding machines (50-450 tonne) with servo-driven precision
• Dedicated material handling with central drying, conveying, and nitrogen blanketing systems
• HEPA-filtered laminar airflow maintaining <352,000 particles ≥0.5μm per m³
• Integrated automated optical inspection (AOI) and CMM verification stations

Quality Infrastructure

• ISO 13485:2016 certified quality management system for medical devices
• 21 CFR Part 820 compliant design and production controls
• Full 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.