Facility's Infrastructure
Facility‘s Infrastructure
As a leading full-service biomaterial management organization (BMO), Kryosphere consistently delivers high quality biorepository services (active and archive sample and material management), pharmaceutical materials from pre-clinical to commercial, cold chain-of-custody logistics, and clinical trial sample management (protocol development, site training, kitting, distribution, and support in accordance with FDA requirements).
Kryosphere ensures all biomaterials are to be managed carefully under designed conditions using GMP compliant standard operating procedures (SOPs). All of our standard operating procedures are well-designed and applied consistently with documented quality control and assurance.
Facility Locations
14001 Weston Parkway
This facility is Kryosphere’s main headquarters; comprised of over 110,000 square feet in a single occupied fabricated concrete structure. Services offered in this building are three repositories each holding 250 ultra-low freezers, six walk-in refrigerators and freezers, a liquid nitrogen freezer farm, ambient & CRT bulk storage, as well as clinical custom kitting. All electrical and data services run in overhead tracks allowing an open floor plan for maximum flexibility in achieving the most efficient unit configuration.
13000 Weston Parkway
Adjacent to this facility is 13000 Weston Parkway. The building is a shared 100,000 square feet and Kryosphere’s currently occupies 60%. 30,000 sq. ft. is dedicated to a Controlled Ambient (CRT) warehouse, 11,000 sq. ft. +2-8o C drive-in cold room, and a 6,000 sq.ft. -20°C Walk-in.
Electric Utilities
The main power feeds to all locations are via underground supply from a regional power station less than 500 meters away. Power mains have been oversized to accommodate expansion needs. All 208 and 120V controlled temperature units are each on individual circuits. Each facility is equipped with generator back-up power. Each facility has redundant generator systems to mitigate even a generator failure. Two (2) 500 kW and three (3) 350kW diesel generators are located at 14001 Weston and two (2) 350kW generators at 13000 Weston Parkway.
Each generator has fuel reservoirs providing a minimum of seven (7) days continual power is maintained and retainer agreements are in place for high priority re-fueling status with multiple fuel suppliers. Automatic transfer switches sense any loss of main power and activate the generators feeding emergency power within seconds. All critical electronic and IT equipment is connected to an uninterruptible power supply so there is no temporary loss of power. The environmental monitoring system sends an alert to all team members in the event the generators are activated. All generators are tested weekly and receive preventative maintenance quarterly by a qualified vendor.
HVAC
The ventilation infrastructure at Kryosphere’s facility was specifically designed to handle the heat load of over 700 mechanical freezers with extra capacity built into the fail-over design. Over 100 tons of cooling capacity is provided to maintain a room temperature of 68⁰ F +/- 4⁰ F. This is achieved by multiple Liebert units or custom HVAC systems operating to provide a horizontal airflow through the repository thus moving the heat away from the equipment and improving their life and performance. In the event of the facility loss of a single or multiple units, the remaining units can maintain ambient temperatures within the desired limits. Units are inspected and preventative maintenance quarterly.
Information Technology Systems
Kryosphere’s information management program consists of an in-house MDF and multiple IDF IT rooms. The Department is managed by an experienced IT Director. Kryosphere maintains a RAID server configuration, ensuring no interruptions because of a failed server or hard drive. Redundant data connections using a separate cellular service is utilized to ensure that all emergency notifications are received. All alerts and alarms are communicated automatically via, email, pager, phone call, and text message. All data is backed up locally and to a cloud service multiple times daily and critical data is hosted off-site at a secure and highly redundant data hosting site. All information management systems are backed up by UPS and generator power.
Facilities Security
Kryosphere maintains a highly secure facility. All access to the facility is controlled through individual card access. There are five points of external access (including the loading dock) each is covered by high-resolution digital video surveillance and card access. Within Kryosphere there are four points of controlled entry into the biomaterial storage area. Within the controlled storage area digital video surveillance captures all activities and all points of access are electronically monitored and limited only to personnel whose roles and responsibilities require admittance.
Emergency Systems
Fire Suppression and Alarms: Kryosphere’s facility meets or exceeds all local and national fire codes and receives an annual inspection by local fire authority. The repository is protected by both a dry chemical suppressant system, FM 200, and a pre-activation wet system. All smoke detectors are connected to a central alarm which is inspected monthly. Temperature and humidity alarms are also connected to our internal temperature monitoring system which sends alerts via multiple communication channels if repository temperatures/humidity exceed parameters.
Interested in KRYOSPHERE?
Ready to get started or just have some more questions? Fill out our contact form and we will be in touch with you as soon as possible.