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EASTERN MEDIKIT LIMITED


Quality Commitment

Our company has adopted a continuous and total quality improvement process. State of the art designed experiments and statistical process control are routinely used throughout the product development and manufacturing process. While all individuals involved in manufacturing are responsible for the quality of their work, our quality engineers and inspection personals are charged with a number of specific responsibilities that verify conformance to requirements. The quality team is also charged with overall in-house inspection and performs final inspection and testing. In our quest for Quality, we at Medikit, have successfully implemented a Quality Management System satisfying Quality System Standards ISO 9001:1994, EN 46001 and European Council Directive 93/42/EEC (Council Directive 93/42/EEC of June 1993 concerning medical devices), as a guide to its quality assurance activity. We have achieved these certifications through an independent audit by SGS Yorsley International Certification Services Ltd., United Kingdom, one of the prestigious and respected institutes for certification. This system is considered the most effective method available today for not only assuring acceptable products and process, but also for predicting potential deviations from the specifications. Such predictability increase productivity and decreases total programme costs for the customer. The quality assurance staff determines the frequency of inspection, the quality of parts to be inspected, and the inspection criteria for individual production runs. All manufactured products are inspected for compliance using documented inspection plans.

Centre Point of Activities

Medikit operates it's manufacturing activities at Gurgaon , an industrial town in the state of Haryana, about 15 minutes drive from Indira Gandhi International Airport, Delhi. Advantageous goods & public transport facilities and a defined pollution free industrial zone have been the key factors for concentrating the activities here. The product that Medikit presently manufacturers are : a wide range of I.V. CATHETERS, THREE WAY STOP COCKS, I.V. INFUSION SETS, FLOW REGULATORS, A.V. FISTULA NEEDLES, BLOOD TUBINGS FOR HAEMODIALYSIS, ENDO TRACHEAL TUBES, OXYGEN MASKS, NEW RANGE OF SAFETY MEDICAL PRODUCTS and many more medical devices for single use. Our manufacturing programs involve an array of specialized equipment, five environmentally controlled clean rooms and a progressive & highly qualified technical team alongwith a dedicated work force. The equipment represents highly advanced production technology. 

Each clean room has a state of the art HVAC system in place. HEPA filtration, positive pressure, controlled temperature, and regulated relative humidity provide a controlled environment for manufacturing. Certification for nonviable particles is conducted at regularly scheduled intervals with in-house equipment. Independent our side verification is also done periodically. The facilities also include in-house ethylene oxide gas sterilization equipments. However, gamma sterilization facilities are available in close proximity of our manufacturing set up. The sterilization process for the aseptically packed goods follow different steps according to specified procedures and are recorded and documented with all details. Though addition of bio-indicators and product sampling, the efficiency of every sterilization batch is confirmed in our own analytical laboratory, which is government approved. 

Manufacturing can be thought as the sum of Medikit's capabilities. It is a result of the vertical integration of our expertise starting with engineering and including tooling, injection moulding, process development, process validation, RF-welding, ultrasonic welding, assembling, packaging and sterilization technology. WE ALSO OFFER A WIDE RANGE OF CONTRACT MANUFACTURING SERVICES. All the operations are monitored carefully through our quality assurance system.

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: Contact Information :

Mr. Bhupinder Singh, Sr. Manager

 

3, Dr. G.C. Narang Marg, Delhi - 110 007, India 

 

Phone : +91 - 11 - 27667 - 131 / 734 / 845 

 

Fax : +91 - 11 - 27667-395 / 361