Medical Plastic Data Service Magazine

 

A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Our 30th Year of Publication
Page  3 of 6
 
 

Cover Story

INNOVATION & DEVELOPMENT IN MEDICAL PLASTICS/ DEVICES & PHARMA PACKING

Mr. Kishore Khanna
Managing Director
Romsons Group Private Limited

FOCUS AREA: Medical Polymers, Applications & Processing

Today's medical devices made from polymers have played a significant role in revolutionizing healthcare for next generation. It has proven as a lifesaving technology.

Medical polymers are an essential part of the modern healthcare system. These polymeric materials need compliance with global regulatory requirement/s. To ensure that the material is safe for use in medical disposables, in-vitro diagnostics and primary packaging for medical devices.


The application of polymers in medical devices is often challenging. Besides meeting highest quality standards, materials need to withstand aggressive disinfectants, pharmaceutics and as well as resist exposure to different sterilization processes without sacrificing mechanical performance.

Furthermore, it needs to be ensured that no harmful interaction takes place in between the material and any body tissues or fluids.

The choice of polymer for a specific device application is often based on many considerations. For example,

Physical Performance

Strength
Flexibility
Modulus
Heat Resistance, etc.

Chemical Resistance

Polar & Nonpolar solvent
Aggressive carrier solvent/s & disinfectant chemicals.
Lipid/s.
Pharmaceutical ingredients /drugs, etc.Regulatory Requirements & Compliance
Meet REACH, RoHS requirements.
Polymer compliance with USP Class-VI, ISO 10993-1 & parts.
Commission regulation (EU) no 10/2011.

Biocompatibility Performance

Invitro Cytotoxicity
Sensitization
Irritation or Intracutaneous Reactivity
Material Mediated Pyrogencity
Acute Systemic Toxicity
Subacute Systemic Toxicity
Implantation
Haemocompatibility
Genotoxicity

Sterilization Performance

Steam / Autoclave.
Ethylene Oxide.
Gamma Irradiation.

Various synthetic polymers & their composites, blend polymers, biodegradables like,

PEBA (Polyether Block Amide)
COC (Cyclic Olefin Co-polymer)
Co-polyester Tritan
Blends PC (Polycarbonate + blended polymer)
FEP (Fluorinated Ethylene Propylene)
PEEK (Polyether Ether Ketone)
Silicon polymer
PPSU (Polyphenyl Sulphone)
PBT (Poly Butylene Terephthalate)

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