COMMERCIAL GRADE AIR PURIFIER

FDA CLEARED AIR HYGIENE TECHNOLOGY

Air purification technology has advanced exponentially in recent years in response to the COVID-19 pandemic. Outside of traditional HEPA filters, companies have been looking towards alternative means of reducing airborne pathogens and particulates. One such method uses UV light to sterilize the HEPA-filtered air. This one-two punch can drastically reduce particulates and pathogens, improving air quality and decreasing the possibility of transmitting airborne disease.

A leading air purification company approached Synectic Product Development to transition their product, utilizing UV-C LED air purification technology, from prototype to production. The company would seek FDA clearance, requiring full quality and regulatory documentation of each process step. They also requested that we design, develop, and validate the unit’s packaging to comply with FDA requirements. Using our new product introduction process, we did the following:

Performed a manufacturing assessment that led to design changes to optimize the design for manufacturing.
Wrote and performed many testing protocols, including airflow testing, to support their claims to the FDA.
Changed initial assembly protocols to address electrostatic issues compromising components.
Built the initial 100 units in-house with complete quality and regulatory documentation.
Developed a box that was strong enough to hold the 44lb machine.
Worked with the packaging vendor to develop foam pieces that were easily manufactured and were shock absorbent.
Developed ship testing protocols and performed packaging validation.
Facilitated the design transfer to our parent company, Mack Molding.

Our efforts ultimately led to the successful production of the PūrGo Air filter, beginning at Synectic’s NPI facility and concluding at our parent company, Mack Molding. Our assistance in navigating the regulatory process led to the device being cleared by the FDA as a Class II medical device. Additionally, the company was able to merge with Mοlekule, another leader in air purification, significantly increasing its stock value.