Friday August 14, 2020 0 comments
BOULDER -- Boulder iQ, a contract consulting firm for high-technology and medical products, announced it is doubling its capacity for ethylene oxide (EO) sterilization of medical devices in a commitment to maintain a four-day turnaround for most sterilization services.
The company’s Boulder Sterilization division uses ethylene oxide, a safe, effective low-temperature method, to sterilize medical device equipment and accessories from biological contaminants, including those from COVID-19
In addition, Boulder Sterilization uses an abator (catalytic converter) system to mitigate outgassing that is inherent in the EO process. While not required in Colorado, the company has opted to incorporate the abator to underscore its commitment to green operations.
“Perhaps now more than ever, medical device companies need to get products to market quickly and efficiently,” said Jim Kasic, Boulder iQ’s president and CEO.
Kaasic cites the fact that with the increased capacity, Boulder Sterilization can accommodate more projects to better serve its clients.
“For entrepreneurs, start-ups and established companies that require sterilization of products, the service that Boulder Sterilization offers is quick, efficient, flexible and reliable,” he said.
Boulder Sterilization process works for healthcare and personal protection equipment (PPE), including N-95 respirators, surgical gowns, and nasal swabs, as well as medical devices and accessories used in COVID-19 testing, treatment, and care.
In these times of PPE shortages, respirators, gowns, and swabs need regular cleaning and decontamination for reuse, Kasic said.
Boulder Sterilization also offers sterile packaging for medical devices sealed in Tyvek pouches, common packaging for medical devices.
Through its regulatory consulting service, Boulder iQ said it is assisting companies in preparing Emergency Use Authorizations for medical devices and in vitro diagnostics.
During a public health emergency, the FDA can use its Emergency Use Authorization authority to allow the use of uncleared or unapproved medical products – or allow for uncleared or unapproved uses of cleared or approved medical products – to diagnose, treat, or prevent serious diseases, such as COVID-19,when certain criteria are met.