Sterilization of a new medical device using broad-spectrum pulsed light.
In the development of implantable medical devices, effective sterilization is an essential design element. This article outlines how broad-spectrum pulsed light (BSPL) has been implemented to sterilize a novel, implantable medical device. Components of the device have properties incompatible with most sterilization techniques. The unique characteristics of the device and sterilization method are described. Results are presented that show BSPL can be an effective sterilization method that has the potential to meet validation requirements to allow parametric release of the treated product.
Wallen
R D
RD
PurePulse Technologies, Inc, 4241 Ponderosa Ave, San Diego, CA 92123, USA.
May
R
R
Rieger
K
K
Holloway
J M
JM
Cover
W H
WH
D004866:Equipment Contamination / Q000517:prevention & control; D006801:Humans; D007221:Industry; D008027:Light; D019064:Product Packaging; D019736:Prostheses and Implants / Q000382:microbiology* / Q000592:standards; D011840:Radiation, Nonionizing; D013242:Sterilization / Q000295:instrumentation / Q000379:methods*