Quality Control
| Quality Control System at Agofa encompasses a comprehensive and exhaustive series of Bacteriological, Chemical, Physical and Visual Tests; and inspections at each pertinent stage in production cycle i.e. from constant surveillance of raw materials, intensive in-process control of all manufactured parts and sub-assemblies to final inspection and testing of finished products. The process is systematic and fully documented, involving trained personnel and most advanced tools and equipments. Under aegis of ISO (International Organization for Standardization) we have successfully installed and implemented a quality management system and are accredited by Benchmark Australia for ISO 9001 : 2000 Certification. All products at Agofa are manufactured as per ISO Quality System. Production Facilities Agofa Group is committed to practice the highest quality standards and provide world-class products to the international market. To provide the highest level of clinical safety, Agofa Group has set-up an integrated plant having in-house facilities for Injection Molding, Assembly, Sterilization and Testing. Assemblies are done in clean-room conditions under air-conditioned halls to avoid contamination. Agofa Group's main strength is the constant vigilance and total dedication of its trained managerial and technical personnel. Today the Agofa Group team consists of over 300 people working round the clock to produce high quality Medical Devices. Medical grade raw materials used in production are tested in conformity to ISO 10993 and USP. In-house acceptance controls are also established to meet the stringent demands of our quality system. Injection molding and assembly processes are performed in controlled production areas. Disposable medical devices are packed and terminally sterilized in controlled areas using equipment with validated processes and packaging materials. In-house ETO sterilization is carried out in conformity to EN 550 Standards. Q.C. Laboratory has been certified to perform Biological, Chemical, Microbiological, Physical, Stability and Sterility Tests. The Lab equipped with state-of-the-art technology and staffed by trained personnel. |
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