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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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