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Processing Medical Plastics?
You not only need to minimize risk and take care of regulatory requirements, but
also take care of performance, patient safety & convenience and price
competitiveness / profitability.
This issue includes articles covering all stages of production starting from
importance of raw material testing, processing of medical plastics,
technological developments in assembling of medical plastic components & medical
devices, preparing for global markets and last but equally important is the
importance of creating circular economy for healthcare plastics. |
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To start with, a good understanding of polymer science and
behavior of polymer materials is very important. Regulatory authorities,
globally including India, require that the plastics are “well-characterized”
with detailed information on material ingredients and formulation, manufacturing
processes etc.
Medical device manufacturers have also to take responsibility for their
suppliers to make sure every supply-chain link is meeting Good Manufacturing
Practices. This calls for collaboration between all parties in the supply chain.
This is why ISO 13485 certification is becoming more and more important also for
suppliers.
Medical Tubing, Components and ingredients including colorants and additives
play vital role in the quality and reliability of the final medical device.
A plastics processor who understands this and who understands its role in the
risk-management process can be a considerable asset to a medical device
manufacturer.
As explained in his article by Dr Manish Rachchh, Director ( R & D ) and CEO,
Accuprec Research Labs Pvt Ltd, with the implementation of MDR 2017, not only
medical device manufacturers but also manufacturers of raw materials /
components have to comply doing various quality tests with details account of
regulatory testing of
medical grade plastics, rubbers & packaging materials.
Medical tubing segment comprises the most dynamic area in the medical device
landscape. This issue highlights some of the important facts related to Medical
Tubing and Medical Tubing Extrusion Process including catheter tubing. Number of
variables affect performance of a finished catheter – the most paramount being
the properties of the raw material and the extrusion process. Careful
consideration of the extrusion process including economy of extrusion is
essential to ensure consistency and repeatability.
This issue covers two more very well researched technical articles by experts
from two leading companies, “Celanese” and “Emerson”. The first one describes
innovation in the material science and describes a case study on manufacturing
of “ High Volume Thin Wall Medical Device Components with Liquid Crystal Polymer
Thermoplastics“. The second one is also case studies and explains “Why it is
Time to Rethink How to Assemble Plastic Medical Devices and Components”.
Continuing with his regular column on Global Markets, Mr Amit Dave in his
article explains “Basics of regulatory framework for medical devices” as a part
of “Preparing
For Global Markets”. The “Circular Economy” article describes an innovative
recycling process for used plastics.
This issue also includes our regular features – Global Trends, “AiMeD” and
Industry News , “Did You Know Column” , Events/Event Reports, Product Gallery
etc.
D.L. Pandya
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