The other important cover story in this issue is on “Sterilization
Technologies for Medical Plastic Products and Devices”.
The Radiation Processing Department of the Raja Ramanna Centre for Advanced
Technology, Indore ( RRCAT ). The facility is licensed by Atomic Energy
Regulatory Board ( AERB ), FDA MP State and has ISO 9001:2015 and ISO 13485 :
2016 certification for providing electron beam processing service for
sterilization ( e-beam sterilization ) for medical devices as per requirements
of ISO 11137.
In a free-wheeling interview to “Medical Plastics Data Service", Mr V C Petwal,
Head, Radiation Processing Lab, RRCAT, has given highlights about this first
ebeam sterilization facility in the country as well as how the Indian Medical
Device Industry can take benefit from this facility.
Cover story includes comparative analysis for various sterilizations methods,
introduction to Plasma Sterilization, Radiation Stability of Various Plastic
materials as well as global scenario for Sterilization Services by Method.
Importance of ISO 13485 for Medical Plastic Materials & Components Suppliers
Plastics Materials & Components used for medical applications need consistent
performance, including resistance to sterilization, chemicals and lipids as well
as biocompatibility and toxicity.
Materials & Components suppliers should have thorough understanding of end-use
application requirements, medical-device regulations that OEMs must meet, risk
management practices and the need for change-control measures in place.
ISO 13485-2016 is the standard governing organizations involved in design,
production, and installation and servicing of medical devices. If upstream
suppliers, like plastics processors, are also certified to the standard, they
provide their customers with the assurance that they have invested in and
understand the medical-device risk-management principles that are core to the
standard.
Mr Amit Dave, in his continuing column introduces important aspects related to
Market Exploration explaining the market selection (or country selection) and
why one should choose and go for a market outside India rather than sticking to
India only. This article also includes other regular features including
Regulatory & Industry New, Event highlights and many more..
D.L. Pandya
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