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INNOVATION & DEVELOPMENT IN MEDICAL PLASTICS/ DEVICES &
PHARMA PACKING
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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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