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Sterilization of Polymeric Implants: Challenges and Opportunities
1Department of Orthopedics and Physical Rehabilitation, Department of Biochemistry and Molecular Biotechnology, UMass Chan Medical School, 55 Lake Avenue North, Worcester, Massachusetts 01655, United States.
ACS Applied Bio Materials
|November 1, 2022
Summary
Sterilizing degradable polymers for medical use is challenging. This review covers sterilization methods and suggests integrating sterility needs early in polymer design for better clinical translation.
Area of Science:
- Polymer Science
- Biomaterials Engineering
- Medical Device Sterilization
Background:
- Degradable and environmentally responsive polymers are crucial for drug delivery and regenerative medicine.
- Clinical translation of these advanced polymers is hindered by sterilization challenges.
- Ensuring polymer integrity during terminal sterilization is a significant unmet need.
Purpose of the Study:
- To review established and novel sterilization methods for polymeric implants.
- To highlight the importance of compatibility between polymer design and sterilization techniques.
- To guide the integration of regulatory and fiscal considerations in early material development.
Main Methods:
- Discussion of industry-standard terminal sterilization methods (e.g., gamma irradiation, ethylene oxide).
- Analysis of aseptic processing techniques.
- Contrast of conventional methods with innovative approaches preserving polymer integrity.
Main Results:
- Established sterilization methods can compromise the properties of sensitive polymers.
- Innovative techniques offer potential for preserving polymer integrity.
- Early consideration of sterilization requirements is critical for successful clinical translation.
Conclusions:
- Sterilization compatibility must be a primary consideration in the design of degradable polymers.
- A proactive approach integrating material science, engineering, and regulatory affairs is essential.
- Addressing sterilization challenges will accelerate the clinical application of advanced polymeric biomaterials.
Keywords:
aseptic processingdegradationoxidative damagepolymeric implantradicalsswellingterminal sterilizationMore Related Videos
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