The manufacturing unit located in Chandapura, Hosur Road, Bangalore, is a state-of-the-art manufacturing facility spanning 4000 square feet. This advanced facility is designed to uphold the highest standards in medical device production and ensures precision, quality, and compliance at every stage of the manufacturing process. It is a cutting-edge manufacturing environment tailored for precision and quality in producing medical devices.

Air-Conditioned Facility: The factory’s design prioritizes optimal workflow and adherence to stringent cleanliness standards. The air-conditioned environment ensures controlled temperature and humidity levels crucial for maintaining the integrity of sensitive medical device manufacturing processes.

Cleanroom Facilities: The factory boasts an environment with an ISO 8-certified cleanroom dedicated to both manufacturing and packing. Equipped with an air handling unit, the cleanroom maintains the highest air quality and particle levels essential for producing sterile medical devices. The ISO 8 cleanroom minimizes the presence of contaminants, ensuring a sterile environment conducive to the production of high-quality medical devices.

State-of-the-Art Equipment: Equipped with state-of-the-art machinery and technology, the factory ensures precision and efficiency in manufacturing. Automated equipment, specialized tools, and cutting-edge systems are employed to maintain accuracy and consistency in production. The manufacturing arsenal comprises state-of-the-art machines sourced from renowned manufacturers in Japan, Germany, and Italy. The facility is also equipped with an ISO 11135-compliant PLC-based ETO sterilizer, needle detectors, air compressors, and specialized packing machines.

Quality Assurance: The facility adheres rigorously to QA protocols and complies ISO 13485 & GMP regulatory standards. Stringent quality control measures are implemented at every stage of production to ensure the safety, efficacy, and compliance of the manufactured medical devices.

Storage and Material Handling: With dedicated Raw Material (RM), Packaging Material (PM), and Finished Goods (FG) storage areas, the facility ensures organized inventory management and efficient material handling. Dynamic pass boxes facilitate the transfer of materials into the cleanroom without compromising cleanliness standards.

Skilled Workforce: The factory employs a skilled and dedicated workforce trained in GMP (Good Manufacturing Practices) and equipped with the expertise to handle the intricacies of medical device manufacturing within a controlled environment.

Innovation and Continuous Improvement: The facility fosters a culture of innovation and continuous improvement. It actively seeks advancements in technology, processes, and materials to enhance manufacturing efficiency, product quality, and overall operational excellence.

Capacity and Scalability: With 4000 square feet of space, the factory is optimized for efficient production while allowing room for potential expansion or customization to accommodate increased demand or evolving manufacturing needs in the medical device industry.

Specialized Testing Facilities: The factory is equipped with sterile stainless steel furniture and specialized equipment essential for medical device manufacturing. Automated folding, packing, sealing, and strapping machines ensure precision and efficiency in packaging. Additionally, peel-strength testing machines, biological incubators, and needle detectors contribute to stringent quality control and assurance measures.

Power Backup: The facility operates on an Uninterruptible Power Supply (UPS) system, ensuring continuity in production processes and safeguarding against power disruptions.

Commitment to Quality and Compliance: Committed to maintaining the highest quality standards, the facility adheres to ISO regulations and compliances, ensuring that all products meet rigorous quality benchmarks.