Sep 23: Syrma Johari MedTech Limited, a medical-device manufacturing company, has expanded its manufacturing footprint with the launch of a new medical plastics and precision molding facility, strengthening its capabilities to support the evolving requirements of medical device, diagnostic and healthcare applications.
Spread across 1.29 lakh sq. ft., with 0.98 lakh sq. ft. currently developed and 0.31 lakh sq. ft. reserved for future expansion, the facility adds dedicated capabilities in injection molding, plastics extrusion and stretch blow molding to SJML’s manufacturing platform. The expansion enables the company to address a broader range of polymer-based components and consumables across varying geometries, material systems and production volumes.
The facility has been developed to respond to the increasing role of engineered plastics in medical and diagnostic products. From housings, cartridges and containers to tubing, fluid-handling components and microfluidic assemblies, polymer components are increasingly central to device functionality and require a combination of dimensional precision, material performance, repeatability, cleanliness and manufacturing consistency.
With 80T, 130T and 280T injection molding capabilities, a 30–80 kg/hr extrusion line and 2.5-litre PET stretch blow molding, the new facility provides SJML with a wider processing platform for medical polymer applications. Secondary capabilities including screen printing, pad printing, laser printing and assembly further extend the range of processes that can be integrated within the manufacturing ecosystem.
The facility also incorporates ISO Class 7 and ISO Class 8 cleanroom environments, enabling controlled manufacturing conditions for applications where particulate control, cleanliness and contamination management are critical. Its material-processing capabilities cover thermoplastics, elastomers and engineering polymers, including PP, PE, PS, PC, TPEs, PA6, PA66 and glass-fibre-reinforced polymer systems, allowing material selection to be aligned with the functional and manufacturing requirements of individual applications.
Building quality and regulatory discipline into manufacturing
The new facility is supported by SJML’s established quality and regulatory framework for medical-device manufacturing. The company operates under an ISO 13485 Quality Management System, with manufacturing systems designed around US FDA regulatory requirements, processes aligned with MDSAP requirements and compliance with applicable CDSCO regulations.
Process and equipment qualification, including IQ, OQ and PQ, forms part of the manufacturing framework, alongside digital traceability, incoming and in-process inspection, final inspection, calibration and risk-based quality controls. Continuous improvement methodologies including CAPA, SPC, FMEA, Kaizen and Quality by Design further support process control, consistency and manufacturing reliability.
Creating a broader medical manufacturing platform
The addition of plastics manufacturing represents an important extension of SJML’s broader medical manufacturing platform, bringing materials, tooling, processing, validation, quality and scale-up capabilities closer together within a single manufacturing ecosystem.
As medical-device and diagnostic architectures become increasingly sophisticated, the ability to develop and manufacture polymer components with greater control over material selection, precision, cleanliness and repeatability becomes an important part of the product development and manufacturing journey. SJML’s expanded capabilities are designed to support this transition from component development to repeatable and scalable production.
With the new facility, SJML further broadens the technologies and production requirements it can address across diagnostics, critical care, medical devices and associated consumables, reinforcing its role as a manufacturing partner for global companies developing and scaling healthcare products.
The expansion marks another step in SJML’s continued investment in manufacturing capabilities, with a focus on building a more integrated, scalable and quality-driven platform for the evolving needs of the global medical and healthcare industry.