Above: Straits Orthopaedics Engineers – Rajkumar Ramakrishnan, Dhayalan Gandhi, and Parveez Ahmed Receive Certificates of Training as Qualified DELTA H Furnace Operators.
PENANG, MALAYSIA — DELTA H is proud to be of continued service to Straits Orthopaedics in Penang, Malaysia, by providing the medical device manufacturer with a Dual Chamber Aerospace Heat Treat (DCAHT™) furnace system. This is the second system DELTA H has provided Straits Orthopaedics for in-house heat treating.
The furnace system, controls, and software are designed for full compliance to the medical accreditation program “MedAccred” as well as the US FDA’s recent recognition and adoption of the Society of Automotive Engineers (SAE) Aerospace Materials Specification 2750 (AMS2750) pyrometry standard. This means medical device production now has the same pyrometry requirement as materials and parts produced for the aerospace and defense industry in terms of furnace/oven calibration, classification and performance requirements.
“Previously medical device pyrometry standards varied somewhat from manufacturer to manufacturer,” says Richard Conway, DELTA H Chief Technology Officer and Founder. “With the adoption of the well-established AMS2750 standard, there is a consistent requirement across the industry. For DELTA H this is an exciting opportunity in a market that now has the same uncompromising demands for performance and accountability which our thermal processing systems are designed for.”
Among the unique features of the DELTA H Dual Chamber Furnace for medical device applications is the ability to slowly heat from ambient temperature to 400°F and back—all while maintaining Class 1 (+/- 5°F) uniformity in the upper oven chamber – typically for medical-grade plastics and composites. The bottom chamber furnace is typically for PH stainless steel with control and uniformity as a Class 2 (+/- 10°F) system and operates to a maximum of 1200°F. The Dual Chamber Furnace System is now certified and qualified for the manufacturing of medical devices and components per the requirements of MedAccred. MedAccred is an accreditation program for critical process manufacturing operations in the production of medical devices.
Straits Orthopaedics can now demonstrate, on-demand, that they are in full compliance with AMS2750, including heat treating batch records, for any parts materials produced. Mr. TH Su, CEO of Straits Orthopaedics shares, “DELTA H is making great contributions to our heat treating technology which is delighting all our customers.”
About DELTA H Technologies:
DELTA H manufactures highly specialized heat treating equipment for the aerospace and defense industry that meets or exceeds the strict and demanding requirements called for by SAE AMS2750E and National Aerospace and Defense Contractors Accreditation Program (Nadcap). DELTA H heat-treating furnaces & ovens provide full accountability and compliance with guaranteed soak times, precision temperature control and uniformity, calibration traceability, irrefutable batch reports, high craftsmanship and reliability, complete training with 24/7 technical support.