Abstract:
:This review article is focused on the sterilization techniques used for polymer-based implantable medical devices as well as the regulatory aspects governing sterile medical devices. Polymeric materials are increasingly used in implantable devices due to their biodegradable and biocompatible nature. Patients and medical staff often prefer long-term implantable devices and these can be achieved using high molecular weight polymers. Sterilization of polymer-based implantable devices is critical. Since all implantable devices must be sterile, the effect of the sterilization method on the different device components (such as, the polymer, the drug, the electronics, etc.) has to be considered. A comprehensive summary of the established sterilization methods is provided along with the possible effects on polymers. In addition, novel sterilization methods are also discussed.
journal_name
Int J Pharmjournal_title
International journal of pharmaceuticsauthors
Tipnis NP,Burgess DJdoi
10.1016/j.ijpharm.2017.12.003subject
Has Abstractpub_date
2018-06-15 00:00:00pages
455-460issue
2eissn
0378-5173issn
1873-3476pii
S0378-5173(17)31130-4journal_volume
544pub_type
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