HIGHPOWER operates out of a newly renovated 16,000 square foot facility located in Rochester, NY. Rochester is considered by many industry experts as the “cradle of sterilization” due to the Wilmot Castle Company (makers of steam autoclaves) being founded there in 1883. Validation testing that is performed by HIGHPOWER is done within this facility, including packaging systems, cleaning and sterilization, as well as sample storage.
The facility is equipped with:
- A state-of-the-art High Temperature Sterilization Laboratory – The main laboratory within the building has multiple FDA 510K cleared steam sterilizers, table top sterilizers, washer disinfectors, and ultrasonic cleaner. Many HIGHPOWER clients have stated that this laboratory is the “nicest and cleanest that they have ever audited.”
- A state-of-the-art Low Temperature Sterilization Laboratory – The low temperature laboratory focuses on hydrogen peroxide sterilization, and is equipped with FDA cleared STERRAD®, VPRO® and Sterizone VP4 units, along with an additional washer disinfector to aid in reusability studies.
- Separate Ethylene Oxide (ETO) Sterilization Area – Although there has been a focus in recent years to move away from ETO, there is still a demand for its use in the reusable medical device market. HIGHPOWER’s 8 cubic foot medical grade sterilizer is fully programmable and uses 3M ETO single use cartridges. Multiple aeration units allow for the ability to run multiple cycles.
- Shelf-Life and Packaging Storage Room – All packaging systems (pouches, wrap and rigid containers) seeking clearance through the US FDA will require a study with a minimum of 30 days of real time shelf life in order to secure a device 510K clearance. Our storage areas mimics the requirements for the areas utilized in healthcare facilities.
- Aerosol Package Integrity Testing Chamber – Besides real time shelf life testing, packaging systems may also require “Whole Package Integrity” testing or “Aerosol Challenge Testing.” At HIGHPOWER, we have two aerosol methods validated for client use. The first is our Whole Package Integrity Aerosol Chamber used to validate the sterile barrier of sterilization pouches, sterilization wraps and reusable rigid container systems. The second is our Microbial Barrier Chamber utilized for Tortuous Path Closure Systems found in many single use medical devices.
- Media Room – Being a life science laboratory, we utilize a number of internal and external media sources and our media room allows us an avenue to keep up with client demand and to stay ahead of supply chain delays.
We welcome client visits and love to show them our facility and equipment. Please reach out to clientservices@highpowervtls.com if interested in scheduling a facility tour.
