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Invited Speakers : Abstracts & Introduction
Abstract:
The films which generally
delivers both environmental and physical protection of the
product inside the package are considered to be good for
packaging medicare products. Which need good barrier
properties and sufficient rigidity. But the most important
requirements are the surface properties for easy to
produce of package. These properties are mainly (I)
sealing (II) sterilization (iii) vacuum metallization (iv)
printing (v) electrical properties and (vi) co-efficient
of friction. Since these properties undergo change during
modification of plastics in this text the importance of
control of the surface properties for packaging product
when designed by blending commercially used packaging
material, polyethylene with other new material is
discussed.
Speaker’s Introduction
Dr. Subhas Chandra Shit is
well known for his expertise in plastics material, their
manufacturing- engineering and testings. He did his M.Sc.
(Organic) from Chemistry Department of IIT, Kharagpur in
1983 and subsequently completed his Ph.D in Polymer
Science from the Materials Science Center of IIT,
Kharagpur under the guidance of Prof. (Dr.) Sukumar Maiti
and support of DST, Govt. of India through Project on
Development of Thermoplastic Elastomers.
After completion of Ph.D
immediately he joined CIPET, Chennai in the capacity of
Technical Officer in 1987. During his stay at CIPET,
Chennai he headed its Plastics Testing Centre and looked
after many industrial projects.
Dr. Subhas Chandra Shit,
Deputy Director, CIPET, Ahmedabad
While working at CIPET Chennai
during 1987 to 1997 he closely associated himself with
Dr.J.S.Anand and Dr.K.Ramamurthy, the then Director and Dy.
Director respectively of CIPET for executing various
prestigious projects like procurement of machineries for
modernizing programmes of CIPET under World Bank
Assistance which was converted to Grant-in-aid by Govt. of
India at a later date and mission mode project for
development of trained manpower for fiber reinforced
plastics and composite industries under TIFAC, DST, Govt.
of India. He was also associated with CIPET, Haldia (Howrah)
at the initial stage in the capacity of project head
(1997).
Prior to his appointment as
Deputy Director, CIPET, Ahmedabad in 2008 he was In-charge
of CIPET, Bhopal in the capacity of Chief Manager
(Project) He also headed its Plastics Testing Laboratory.
While heading CIPET Bhopal he also side by side looked
after CIPET Panipat project at initial stage (2005).
Because of his continuous 22
years of service at CIPET he has a very broad industrial
contact. He also worked in various training and research
programmes related to rheology, recycling, reaction
extrusion, reinforced plastics and composites, compounding
and application development of plastics under UNIDO
experts like Prof. (Dr.) S.B. Driscoll, University of
Massachusetts, USA; Prof. (Dr.) Ing. G. Menning,
University of Chemnitz, Germany, Prof. (Dr.) M. Xanthos,
PPI, USA. & Prof. (Dr.) L.A. Utracki.
He has about 80 publications
(including national, international and trade journals) out
of which he has more than 50 articles which he himself has
authored. He also played the role of reviewer for some
International Journal in the field of polymer material.
He also conducted many long
term training programmes at CIPET both for Diploma as well
as for Post Diploma level. He coordinated many short term
programmes for industrial personnel as well as Graduate
and Post Graduate students. He organized national seminar
as well as faculty development programmes in the relevant
areas.
He has also professional
experience in quality management in line with ISO
9000-2001 QMS, DFSS and NABL.
He is a member of GSPMA
(Gujarat State Plastics Manufacturers Association). He
represented many technical committees of BIS (Bureau of
Indian Standards).
Abstract:
In regulated markets of the world strict controls are
enforced for ensuring safety of medical devices to the
users. Government of India too has recently taken
initiatives to bring medical devices under regulatory
controls. The matrices of required safety tests differ
with the type of medical devices, the part of body with
which it comes in contact, the nature of contact and
duration of such contact. Different types of toxicity
studies have been designed to assess hazard potentials of
medical devices in terms of their cytotoxicity,
allergenicity, local tissue reaction, systemic toxicity by
acute and/or repeated exposure, reproductive toxicity,
toxicity to genetic material of the cells etc. There exist
differences across countries in specifying safety
requirements and the testing procedures and serious
attempts are on way to bring in a global harmonisation
with respect to these. These tests which support the
safety of products in regulatory dossiers are required to
be conducted in compliance with Good Laboratory Practices
(GLPs) to become acceptable to regulatory agencies. Indian
medical device industry, which is poised for growth with a
focus on National and International markets need to become
aware of such safety standards so as to compete with other
global players. This industry has to work closely with
reputed and GLP certified CROs of India to attain this
mission.
Speaker’s Introduction
Dr. Narendra S. Deshmukh looks
over the responsibility of the Technical Director at INTOX
and is a founder Director of INTOX PVT. LTD. Dr. Deshmukh
earned his Master’s degree (M. V. Sc.) in Veterinary
Pathology in 1990 from the Department of Pathology, Bombay
Veterinary College, Mumbai, and later completed his
curriculum for a Ph.D. (Veterinary Pathology) from the
same Department, from where he is in process of thesis
submission. After working in a toxicological CRO for 4.5
years (1990-1994) he joined Ranbaxy Research Laboratories,
New Delhi where, during 1994-1996, he was instrumental in
establishment of the pre-clinical toxicology laboratory of
Ranbaxy’s New Drug Discovery Research (NDDR).
In December 1995 Dr. Deshmukh
co-founded a toxicological CRO, INTOX, with few more
colleagues, which became operational since 1996.
Today after 13 years of its
foundation, INTOX PVT. LTD. is one of the premier GLP
Certified toxicological CROs of India. INTOX has been
accredited for compliance with GLP (OECD Principles of
Good Laboratory Practice) by Government of The Netherlands
and also by Department of Science and Technology,
Government of India. Since 1996, and during his previous
assignments, Dr. Deshmukh has been involved in planning
and executing several types of safety assessment
(toxicity) studies on a diverse range of products such as
chemical and biological pharmaceuticals and plant
protection products including GM plants and also medical
devices.
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